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DAS 181

Drug Profile

DAS 181

Alternative Names: DAS 181-F02; DAS181; DAS181-F04; Fludase; NEX DAS181; ParaDase

Latest Information Update: 14 May 2020

At a glance

  • Originator NexBio
  • Developer Ansun Biopharma; NexBio
  • Class Antivirals; Recombinant fusion proteins
  • Mechanism of Action Virus internalisation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Parainfluenza virus infections
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Parainfluenza virus infections
  • Phase II COVID 2019 infections; Influenza virus infections
  • Research Metapneumovirus infections
  • No development reported Enterovirus infections; Polyomavirus infections; Respiratory syncytial virus infections

Most Recent Events

  • 30 Apr 2020 Ansun Biopharma in collaboration with Renmin Hospital of Wuhan University completes a compassionate use phase II trial for COVID-19 infections (NCT04324489)
  • 21 Apr 2020 Ansun Biopharma plans a phase II/III trial in COVID-2019 infections in Italy (Inhalation) in July 2020 (NCT04354389) (EudraCT2020-001874-30)
  • 02 Apr 2020 Clinical trials in COVID-2019 infections in USA (Inhalation)

Development Overview

Introduction

DAS 181 is a recombinant fusion protein, being developed by Ansun Biopharma (previously NexBio) for the prevention and treatment of influenza virus infections (including potential pandemic strains) and also infection by parainfluenza viruses (i.e. those that may cause serious respiratory illness similar to influenza, and for which there is no approved therapeutic or vaccine). DAS 181 consists of two parts: a sialidase moiety and a cell-surface anchoring domain, which is designed to attach to the respiratory epithelium and thereby increase retention time and drug potency. DAS 181 has been shown to inactivate viral receptors on the cells of the human respiratory tract, thereby preventing influenza and other viruses (e.g. parainfluenza) from both infecting the human body and amplifying in already-infected individuals. The drug works by a mechanism of action different from all other antiviral drugs already on the market (e.g. neuraminidase inhibitors such as Tamiflu®) or drugs already in development. Because DAS 181 has been developed to block the virus by acting on a human cellular function (host target), rather than a viral protein (pathogen target), it is expected that DAS 181 should be less likely to result in acquired resistance. DAS 181 is administered via nebulised formulation using Aerogen® Solo aerosol drug delivery technology. Ansun believes that DAS 181 may inhibit COVID-2019 virus through multiple potential mechanisms of action inclusive of modification of the host receptor, endocytosis interference, prevention of cell-to-cell spread, and immunomodulation. Clinical development for influenza virus infections is underway in the US and China, and clinical development for parainfluenza virus infections is underway in the US. Clinical development is also underway in the US and China for COVID-2019 infections. The protein is in preclinical development for polyomavirus (papovavirus) infections and enterovirus infections in the US. Early research is ongoing in respiratory syncytial virus (RSV) and metapneumovirus (MPV) in the US.

In November 2011, NexBio changed its name to Ansun Biopharma (NexBio Form D filed in May 2014).

Preclinical development in polyomavirus-infections was underway in the US but development in this indication seems to be discontinued.

As at October 2019, no recent reports of development had been identified for preclinical development in Enterovirus infections in USA.

As at January 2020, no recent reports of development had been identified for research development in Respiratory-syncytial-virus-infections in USA (Inhalation).

Company Agreements

NexBio received a $US50 million contract from the NIH to support development of DAS 181.

In August 2005, NexBio received a $US6 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the US NIH to fund further testing of DAS 181 [1] . NexBio reported in August 2011 that the development of DAS 181 continued to be funded by the NIAID [2] [3] .

Key Development Milestones

Asthma

In November 2010, NexBio reported positive results from in vitro and in vivo models, showing that independent of its antiviral activity, and by a different mechanism of action, DAS 181 may provide benefit in patients with airway diseases such as asthma and COPD [4] . The results build on previous studies of DAS 181 in three animal models of asthma. DAS 181 inhibited airway hyperreactivity, and also decreased the number of inflammatory and mucous-secreting cells in the respiratory tract. The drug was considered to be as effective as a bronchodilator or a steroid (used as antiasthma drugs in the marketplace) in the animal models [5] . However, no recent development in this indication has been reported.

Coronovirus infections (COVID-19)

In April 2020, Ansun Biopharma initiated and enrolled fist patient in a randomised, double-blind, placebo-controlled proof-of-concept trial, to assess the safety and efficacy of DAS 181, for the treatment of severe COVID-19 pneumonia. The two-stage trial is a randomised, double-blind study and intends to initially enrol approximately 22 patients in the US, and further expansion will be undertaken to initiate a second stage of this adaptive design trial, enrolling approximately 60 more patients in the US and Europe, following an interim review of data [6] [7] [8] .

In April 2020, Ansun Biopharma in collaboration with Renmin Hospital of Wuhan University, completed a compassionate use phase II study to assess the safety and efficacy of DAS 181 in patients with COVID-19 infections (NCT04324489; DAS181-SARS-CoV-2). The open-label trial initiated in March 2020, enrolled four patients in China. Favourable preliminary data from the trial were released in April 2020 [7] [9] .

Influenza virus infections

Ansun Biopharma, in April 2020, reported that the phase IIb STOP-Flu trial was underway, to assess the efficacy, safety and pharmacokinetics of DAS 181 in the treatment of severe hospitalised influenza virus infections, inclusive of SAD-RV Infection and COVID-19 infections (NCT04298060; DAS181-2-07). The randomised, double-blinded, placebo-controlled trial intends to recruit approximately 280 patients in China. Earlier, in October 2019, National Medical Products Administration approved the IND application for the trial [7] [10] [11] .

In January 2014, Ansun completed a phase IIb trial that evaluated safety and efficacy of DAS 181 in patients with naturally acquired influenza (NCT01740063; DAS181-2-04). The randomised, double-blind, placebo-controlled trial, initiated in November, enrolled 423 patients in the US [12] .

In August 2011, NexBio reported the completion of a phase II trial of DAS 181 in 297 subjects with laboratory-confirmed influenza, including influenza A virus H1N1 and H3N2 subtypes and influenza B strains (NCT01037205). Topline results showed that the trial had met its primary endpoint of reduction in viral load. The trial, which began in January 2010, ran through two Northern Hemisphere influenza seasons and one Southern Hemisphere influenza season and assessed the effect of DAS 181 on influenza viral load as measured by the amount of viral shedding in the upper respiratory tract. Patients were recruited at sites in the US and Mexico [3] [13] [14] .

In July 2015, Ansun Biopharma reported that the viral load, in the patient with ill cystic fibrosis, was not cleared on treated with tamilfu and then with relenza IV. The patient cleared viral load on treating with DAS 181, under an IND emergency use [15] .

The National Institute of Allergy and Infectious Diseases (NIAID) completed a single- and multiple-dose phase I trial of DAS 181 in healthy volunteers (NCT01173224). This investigator-sponsored trial investigated inhaled single drug doses of 20mg and 30mg, as well as a total dose of 200mg over 10 consecutive days. A total of 18 subjects were recruited [16] .

In August 2011, Ansun Biopharma in collaboration with National Institutes of Health completed a phase I trial that evaluated the safety of DAS 181 in adult patients with well-controlled asthma or bronchiectasis (DAS181-1-04; 10-I-0085; NCT01131286; NCT01113034). The randomised, double-blind, placebo-crossover trial was initiated in July 2010 and enrolled 11 patients in the US [17] .

In December 2008, NexBio completed a phase Ia trial of DAS 181 in approximately 36 healthy volunteers (NCT00527865). The drug was found to be well tolerated at all dose levels tested [18] . This trial evaluated four different doses of DAS 181 (0.5mg, 1.0mg, 2.25mg and 4.5mg) [19] .

A second phase I trial was completed in December 2009 in the US in 45 healthy adults (NCT00876161). This trial evaluated three doses of DAS 181 (5mg, 10mg and 20mg) for safety, tolerability and pharmacokinetics [20] .

Following the declaration of an influenza A virus H1N1 subtype (swine flu) pandemic in June 2009, NexBio had been testing DAS 181 against this current pandemic strain of influenza. The company had also conducted previous investigations in collaboration with the US Centers for Disease Control and Prevention (CDC) during the avian influenza (bird flu) outbreak from about 2004 onwards [21] .

DAS 181 has shown potent inhibitory activity against multiple human influenza strains, including the 2009 influenza A/H1N1 (Novel H1N1 or "Swine flu"), oseltamivir-resistant influenza virus and the H3N2 strain [22] [23] [24] [25] .

Parainfluenza virus infections

In October 2017, the US FDA awarded breakthrough therapy designation to DAS 181 for parainfluenza virus infections [26] .

In July 2015, fast track designation status was granted to DAS 181 by the US FDA. The US FDA also granted an orphan drug designation to DAS 181 (ParaDase) [27] [28] .

In May 2019, Ansun Biopharma initiated and enrolled the first patient in the phase III STOP PIV trial designed to assess the safety and efficacy of DAS 181 in immunocompromised patients with lower respiratory tract parainfluenza infection (NCT03808922; DAS181-3-01). The randomised, placebo-controlled trial intends to enrol approximately 132 patients in the US and might expand to Europe and Asia including Chin [29] [30] . In October 2019, NMPA approved the IND for DAS 181 phase III trial in China [10] .

Ansun, in May 2017, completed a phase II trial that examined effects of DAS 181 administered either as a dry powder inhalation or a nebulised formulation in immunocompromised patients with parainfluenza virus infections (NCT01924793; DAS181-2-06). The primary outcome of the trial was the cumulative incidence and severity of adverse events over two years. The trial, initiated in August 2013, enrolled 23 patients in the US [31] .

In December 2016, Ansun completed a phase II trial that assessed the safety and tolerability of DAS 181 in immunocompromised patients with parainfluenza virus infections, on supplemental oxygen (NCT01644877; DAS181-2-05). The randomised, double-blind, placebo-controlled trial, initiated in March 2014, enrolled 111 patients in the US. In October 2018, Ansun Biopharma presented results from this trial at the IDWeek 2018. Results showed that DAS 181 was well tolerated and showed a signal for clinical efficacy in immunocompromised patients with parainfluenza virus lower respiratory tract infection [32] [33] .

In October 2015, Ansun announced successful treatment with DAS 181 in a transplant patients on a respirator who were co-infected with influenza and parainfluenza. The drug was used under an emergency IND [34] .

NexBio reported in August 2011 that DAS 181 had been used, under an emergency IND (eIND) granted by the US FDA, to treat four patients who were severely immunocompromised and experiencing parainfluenza pneumonitis. Significant improvement in clinical symptoms was noted in all cases after administration of DAS 181. The company stated that this outcome justified conducting controlled clinical trials of DAS 181 in this indication. NexBio declared that it was executing a broad clinical development plan for DAS 181 that included the aim of showing activity against influenza as well as parainfluenza [2] .

Positive preclinical results were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC-2012) [35] .

Enterovirus infections

Ansun, in September 2015, reported positive efficacy of DAS 181 against enterovirus 68 in in vitro studies which suggest clinical evaluation of the candidate against enteroviral infections [36] .

Polyomavirus infections

In a preclinical study, DAS 181 showed activity against JC and BK viruses, two viruses that occur in immunocompromised patients [37] .

Respiratory Syncytial Virus (RSV)

Lower concentrations of DAS 181 exhibited of RSV compared with ribavarin in in vitro studies. DAS 181 showed activity against various respiratory pathogens based on the same host-directed antiviral mechanism [27] [38] .

Metapneumovirus (MPV)

DAS 181 exhibited potent in vitro inhibition of MPV. DAS 181 blocked infection of human MPV strains A2, B1 and B2 at low concentrations. Pre-incubation of Hep-2 cells with DAS 181 exhibited inhibition of binding of MPV G protein to Hep-2 cells [27] .

Financing information: In May 2018, Ansun BioPharma announced the completion of an $US85 million Series A financing round, the proceeds from which will fund a phase III trial of DAS 181 [39] .

Patent Information

In February 2010, NexBio was issued US Patent No. 7 645 448 entitled "Class of Therapeutic Protein Based Molecules". The patent covers NexBio′s sialidase pharmaceutical compositions, including DAS 181, and methods of treating or preventing viral infection by influenza and parainfluenza with such compositions. Ansun has several other US and international patent applications pending that cover DAS 181, some of which have been issued in ex-US countries [40] .

Drug Properties & Chemical Synopsis

  • Route of administration Inhalation
  • Formulation Liquid, Powder, unspecified
  • Class Antivirals, Recombinant fusion proteins
  • Target Virus internalisation
  • Mechanism of Action Virus internalisation inhibitors
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5B (Antivirals, excluding anti-HIV products)

    J5B4 (Influenza antivirals)

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

influenza A virus H1N1 subtype

Outcome Measure

Haptoglobin

1

influenza virus infections

not specified

Haptoglobin

1

influenza virus infections

Outcome Measure

Haptoglobin

2

Biomarker

Drug Name Biomarker Name Biomarker Function
DAS 181 Haptoglobin Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections bilateral viral pneumonia and hypoxemia - Phase II China Inhalation / unspecified Ansun Biopharma 06 Mar 2020
COVID 2019 infections COVID-2019 pneumonia - Clinical Phase Unknown USA Inhalation / unspecified Ansun Biopharma 02 Apr 2020
Enterovirus infections - - No development reported (Preclinical) USA unspecified / unspecified Ansun Biopharma 28 Oct 2019
Influenza virus infections - - Phase II China Inhalation / unspecified Ansun Biopharma 02 Apr 2020
Influenza virus infections - - Phase II USA Inhalation / Powder Ansun Biopharma 08 Jan 2010
Influenza virus infections In patients with asthma and bronchiectasis Prevention No development reported (I) USA Inhalation / Powder NexBio 28 Aug 2013
Metapneumovirus infections - - Research USA unspecified / unspecified Ansun Biopharma 27 Sep 2016
Parainfluenza virus infections In hospitalized and immunocompromised patients In adolescents, In adults, In the elderly Phase III USA (fast track) Inhalation / Powder Ansun Biopharma 23 May 2019
Parainfluenza virus infections - In adolescents, In adults, In the elderly Phase II USA (fast track) Inhalation / Liquid Ansun Biopharma 01 Aug 2013
Polyomavirus infections - - No development reported (Preclinical) USA Inhalation / Powder Ansun Biopharma 28 Oct 2018
Respiratory syncytial virus infections - - No development reported (Research) USA Inhalation / unspecified Ansun Biopharma 28 Jan 2020

Priority Development Status

Type Region Indication
Fast Track US Parainfluenza virus infections

Orphan Status

Indication Patient Segment Country Organisation Event Date
Parainfluenza virus infections - USA Ansun Biopharma 27 Sep 2016

Commercial Information

Involved Organisations

Organisation Involvement Countries
NexBio Originator USA
Ansun Biopharma Owner USA
Renmin Hospital of Wuhan University Collaborator China
National Institutes of Health (USA) Collaborator USA

Brand Names

Brand Name Organisations Indications Countries
Fludase Ansun Biopharma Influenza virus infections USA
ParaDase Ansun Biopharma Parainfluenza virus infections USA

Scientific Summary

Adverse Events

Topline results of a phase II trial showed that DAS 181 was well tolerated in patients with influenza virus infections. In the randomised, double-blind trial, 297 such patients received placebo, a single dose of DAS 181 10mg or three once-daily doses of DAS 181 10mg. Four serious adverse events were reported; two of these were in placebo recipients and two in recipients of single-dose DAS 181 10mg. None of the serious adverse events was considered to be associated with DAS 181 [3] .

NexBio has completed two phase I trials with increasing single and multi-dose regimens of DAS 181 in healthy subjects. The drug was well tolerated and there were no serious adverse events [42] .

Results from a phase II trial showed that both placebo and DAS181 treated group demonstrated similar adverse events.
Comparable day 45 all-cause mortality was observed in both groups (32.4% DAS181 versus. 31.4% placebo. The randomised, double-blind, placebo-controlled trial assessed the safety and tolerability of DAS 181 in 110 immunocompromised patients with parainfluenza virus infections, on supplemental oxygen [32] [33] .

Pharmacodynamics

Summary

Mechanism of action

DAS 181 works by inactivating the human host receptor for all influenza and parainfluenza viruses tested to date, including influenza A virus H5N1 subtype (bird flu) and influenza A virus H1N1 subtype (pandemic swine flu). DAS 181 has been shown to remove two types of influenza sialic acid (Sia) receptors found in human lung tissue: A2-6-linked (H1N1 virus preferentially binds to this receptor) and A2-3-linked (H5N1 virus preferentially binds to this receptor) [21] .

Desialylation of airway muscarinic receptors in both in vivo and in vitro models unexpectedly reduced muscarinic pathway signalling. Mice administered DAS 181 once daily for three days at doses lower than those used for antiviral treatment, showed significantly reduced airway resistance in response to challenge by methacholine [4] .

Influenza virus infections

in a preclinical study in mice challenged with a lethal dose of influenza virus (H1N1 or H3N2), treatment with DAS 181 not only inhibited influenza virus and prevented weight loss, but also prevented bacterial pneumonia. It was proposed that DAS 181 limited the airway epithelial damage caused by influenza virus infection, protecting the epithelium from inflammation and thereby preventing secondary bacterial infection [22] .

In vitro

studies showed efficacy of DAS 181 against panels of 2009 (n=9), 2007 (n=2) and 2004 (n=2) H1N1 clinical isolates. These isolates included a strain resistant to all three neuroaminidase inhibitors (oseltamivir, zanamivir and peramivir) [43] .

DAS 181 demonstrated strong and comparable inhibitory activity against several 2009 influenza A/H1N1 and seasonal influenza strains, in vitro, in vivo and ex vivo. In addition, inhibition was observed against an oseltamivir resistant strain (H274Y) [43] [23] [25] .

Inhibition of a neuraminidase inhibitor resistant strain (A/Victoria/3/75(H3N2)) was recorded in mice treated with DAS 181. In vitro activity against oseltamivir-resistant influenza was also confirmed in vitro [43] [24] .

Preclinical studies conducted in collaboration with the US Centers for Disease Control and Prevention (CDC) have shown DAS 181 had significant prophylactic and therapeutic activity in an in vivo animal model for a highly virulent H5N1 (A/VN/1203/04) strain of influenza. In another study conducted in collaboration with the University of Hong Kong, it was shown for the first time that DAS 181 strongly inhibited H5N1 (A/VN/3046/2004) in human lung tissue and cells. The study in human tissue also demonstrated that DAS 181 effectively removed the two types of sialic acid (Sia) receptors to which influenza virus binds - A2-6-linked and A2-3-linked Sia receptors. Most importantly, virus was suppressed by inactivation of the entry receptors following DAS 181 treatment [21] .

Parainfluenza virus infections

results from studies in vitro and in vivo showed that DAS 181 inhibited infection with multiple human parainfluenza virus strains, at concentrations at low as 0.1nM [35] [41] .

Therapeutic Trials

Results from a phase II trial showed that 39.2% of DAS 181-treated patients achieved day 45 clinical stability survival (CSS) compared to 31.4% of placebo (p=0.29), while the proportion among non-MV (mechanical ventilation) patients was 45.0% vs. 31.0% (difference -14.0%, p=0.15), respectively. DAS181-treated patients had shorter time to CSS in the non-MV stratum. DAS181-treated patients a lower demonstrated median change in nasopharyngeal PIV viral load by day 10 (-1.44 versus -0.68 log10 (p=0.51) and median hospitalization days (13.5 versus 21 days (p= 0.10) as compared to placebo treated patients. Mean absolute increase from baseline FEV1% predicted was 16.82 for DAS 181 versus 2.02 for placebo (p =0.001). DAS181 reduced SO need in the non-MV stratum after day 21 (p=0.09) as evident from the post-hoc analysis on the probability to return to room air (RTRA). Hematopoietic cell transplant (HCT) recipients within 360 days from transplant demonstrated a 40.8% treatment effect on probability to return to room air (RTRA) at day 28 (p= 0.04) and 36.7% on mortality at day 45 as compared to placebo treated patients (p= 0.06). The randomised, double-blind, placebo-controlled trial assessed the safety and tolerability of DAS 181 in 110 immunocompromised patients with parainfluenza virus infections, on supplemental oxygen [32] [33] .

Topline results of a phase II trial showed that viral load was significantly reduced in patients with influenza virus infections who received DAS 181 10mg once daily for 3 days, compared with placebo recipients, over the first 24 hours, the first 48 hours and from day 1 to day 5 (all p < 0.01). In the randomised, double-blind trial, 297 such patients received placebo, a single dose of DAS 181 10mg or three once-daily doses of DAS 181 10mg. A sustained reduction in viral shedding was achieved in significantly less time in recipients of DAS 181 10mg once daily for 3 days than in placebo recipients (p < 0.003) [3] .

In a transplant patient co-infected with influenza and parainfluenza, use of DAS 181 for over a five day course, reduced the oxygen requirement of the patient, improving the respiratory status of the patient, thereby allowing patient to go off the respirator on day 5. A 60-fold reduction in influenza viral load in the patient's tracheal aspirate and 7-fold reduction in PIV RNA viral load was observed between day 2 and day 4 of DAS 181 dosing. Following the discontinuation of the respirator, NP swabs were negative for both the viruses [34] .

Preliminary results from an investigator-initiated programme in four evaluable patients showcased that the first two patients precluded the need for supplemental oxygen while displaying stabilised vital signs, enhanced oxygen saturation and infiltrate resolution, as apparent from chest CT scans. The third patient, who was a persistent SARS-CoV-2 carrier for more than 33 days, was completely relieved of the virus, before the end of the 10th day drug regimen, meeting all discharge criteria. The fourth patient was undergoing treatment and exhibiting positive trends [7] [9] .

Future Events

Expected Date Event Type Description Updated
31 Jul 2020 Trial Update Ansun Biopharma plans a phase II/III trial in COVID-2019 infections in Italy (Inhalation) in July 2020 (NCT04354389) (EudraCT2020-001874-30) 24 Apr 2020
31 Mar 2020 Trial Update Ansun Biopharma plans the phase IIb STOP Flu trial for severe Influenza virus infections in China (Inhalation), in March 2019 (NCT04298060) (700314480) 08 Apr 2020
23 May 2019 Trial Update Ansun Biopharma plans a phase III trial for Influenza virus infection in February 2019 (NCT03808922) (700289337) 29 May 2019

Development History

Event Date Update Type Comment
30 Apr 2020 Trial Update Ansun Biopharma in collaboration with Renmin Hospital of Wuhan University completes a compassionate use phase II trial for COVID-19 infections (NCT04324489) Updated 14 May 2020
21 Apr 2020 Trial Update Ansun Biopharma plans a phase II/III trial in COVID-2019 infections in Italy (Inhalation) in July 2020 (NCT04354389) (EudraCT2020-001874-30) Updated 24 Apr 2020
02 Apr 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in USA (Inhalation) [7] Updated 08 Apr 2020
02 Apr 2020 Phase Change - II Phase-II clinical trials in Influenza virus infections in China (Inhalation) [7] Updated 08 Apr 2020
02 Apr 2020 Scientific Update Favourable preliminary efficacy data from a phase II trial in COVID-2019 infections released by Ansun Biopharma [7] Updated 08 Apr 2020
06 Mar 2020 Trial Update Ansun Biopharma plans the phase IIb STOP Flu trial for severe Influenza virus infections in China (Inhalation), in March 2019 (NCT04298060) Updated 08 Apr 2020
06 Mar 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections in China (Inhalation) (NCT04324489) Updated 31 Mar 2020
28 Jan 2020 Phase Change - No development reported No recent reports of development identified for research development in Respiratory-syncytial-virus-infections in USA (Inhalation) Updated 28 Jan 2020
28 Oct 2019 Phase Change - Preclinical Preclinical trials in Influenza virus infections in China (Inhalation) before Ocotber 2019 [10] Updated 07 Nov 2019
28 Oct 2019 Regulatory Status National Medical Products Administration approves IND application for phase III trial of DAS 181 in Parainfluenza virus infections [10] Updated 07 Nov 2019
28 Oct 2019 Trial Update Ansun Biopharma plans a phase IIb STOP FLU trial in Influenza virus infection in China [10] Updated 07 Nov 2019
28 Oct 2019 Phase Change - No development reported No recent reports of development identified for preclinical development in Enterovirus infections in USA Updated 28 Oct 2019
28 May 2019 Trial Update Ansun Biopharma initiates enrolment in the phase III STOP PIV trial in Parainfluenza virus infections (In adolescents, In adults, In the elderly) in USA (Inhalation) (NCT03808922) [29] Updated 29 May 2019
28 May 2019 Phase Change - III Phase-III clinical trials in Parainfluenza virus infections (In adolescents, In the elderly, In adults) in USA (Inhalation, powder) (Ansun Biopharma website, January 2019) Updated 11 Jan 2019
18 Jan 2019 Trial Update Ansun Biopharma plans a phase III trial for Influenza virus infection in February 2019 (NCT03808922) Updated 29 May 2019
28 Oct 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Polyomavirus-infections in USA (Inhalation, Powder) Updated 28 Oct 2018
08 Oct 2018 Trial Update Ansun Biopharma plans a phase III trial for Parainfluenza virus infections Updated 11 Oct 2018
03 Oct 2018 Scientific Update Efficacy and adverse events data from a phase II trial in Parainfluenza virus infections presented at IDWeek 2018 [32] Updated 06 Nov 2018
24 Jun 2018 Biomarker Update Biomarkers information updated Updated 31 Aug 2018
10 Oct 2017 Regulatory Status DAS 181 receives Breakthrough Therapy status for Parainfluenza virus infections in USA [26] Updated 11 Oct 2017
10 Oct 2017 Regulatory Status DAS 181 is available under expanded access programme for the treatment of Parainfluenza virus infections in USA [26] Updated 11 Oct 2017
10 Oct 2017 Trial Update Ansun BioPharma plans a phase III trial in Parainfluenza virus infections [26] Updated 11 Oct 2017
01 May 2017 Trial Update Ansun completes a phase II trial in Parainfluenza virus infections (In adolescents, In adults, In the elderly) in USA (Inhalation, Powder and Liquid) (NCT01924793) Updated 25 Jul 2017
15 Dec 2016 Trial Update Ansun Biopharma completes a phase II trial for Parainfluenza virus infections in USA (NCT01644877) Updated 25 Jul 2017
27 Sep 2016 Phase Change Early research in Metapneumovirus-infections in USA (unspecified route) [27] Updated 30 Sep 2016
27 Sep 2016 Regulatory Status DAS 181 receives Orphan Drug status for Parainfluenza virus infections in USA before September 2016 [27] Updated 30 Sep 2016
15 Dec 2015 Phase Change Early research in Respiratory syncytial virus infections in USA (Inhalation) Updated 15 Dec 2015
09 Oct 2015 Scientific Update Efficacy data from a transplant patient co-infected with Influenza and Parainfluenza virus infections released by Ansun BioPharma [34] Updated 14 Oct 2015
28 Sep 2015 Phase Change - Preclinical Preclinical trials in Enterovirus infections in USA (unspecified route) [36] Updated 17 Oct 2015
28 Jul 2015 Regulatory Status DAS 181 receives Fast Track designation for Parainfluenza virus infections [Inhalation,Powder] in USA [28] Updated 04 Aug 2015
09 Sep 2014 Phase Change - Preclinical Preclinical trials in Papovavirus infections in USA (Inhalation) Updated 03 Nov 2014
10 Apr 2014 Licensing Status DAS 181 appears to be no longer available for licensing (http://www.nexbio.com) Updated 10 Apr 2014
01 Mar 2014 Trial Update Ansun Biopharma initiates enrolment in a phase II trial for Parainfluenza virus infection (In adolescents, In adults, In the elderly) in USA (NCT01644877) Updated 14 May 2014
01 Jan 2014 Trial Update Ansun Biopharma completes a phase-IIb trial in Influenza virus infections in USA (Inhalation) (NCT01740063) Updated 16 Jul 2019
28 Aug 2013 Phase Change - No development reported(I) No development reported - Phase-I for Influenza virus infections (prevention) in USA (Inhalation) Updated 28 Aug 2013
28 Aug 2013 Phase Change - No development reported(Preclinical) No development reported - Preclinical for Asthma in USA (unspecified route) Updated 28 Aug 2013
27 Aug 2013 Trial Update Ansun Biopharma plans a phase II trial for Parainfluenza virus infections in USA (NCT01924793) Updated 27 Aug 2013
01 Aug 2013 Phase Change - II Phase-II clinical trials in Parainfluenza virus infections in USA (Inhalation, Liquid) (NCT01924793) Updated 25 Jul 2017
01 Aug 2013 Phase Change - II Phase-II clinical trials in Parainfluenza virus infections (In adolescents, In adults, In the elderly) in USA (Inhalation, Powder) (NCT01924793) Updated 03 Feb 2014
11 Jul 2013 Trial Update Ansun Biopharma completes enrolment in its phase IIb trial for Influenza virus infections in USA (NCT01740063) Updated 28 Aug 2013
28 Nov 2012 Trial Update NexBio plans a phase IIb trial for Influenza virus infections in USA (NCT01740063) Updated 23 Jan 2013
12 Sep 2012 Scientific Update Pharmacodynamics data from a preclinical trial in Parainfluenza virus infections presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC-2012) [35] Updated 20 Sep 2012
10 Nov 2011 Company Involvement NexBio is now called Ansun Biopharma Updated 03 Nov 2014
22 Aug 2011 Trial Update Ansun Biopharma and National Institutes of Health completes a phase I safety trial in patients with Asthma and Bronchiectasis (In adults) in USA (NCT01113034) Updated 03 Apr 2019
15 Aug 2011 Scientific Update Topline efficacy and adverse events data from a Phase-II trial in Influenza virus infections released by NexBio [3] Updated 16 Aug 2011
15 Aug 2011 Trial Update NexBio completes a Phase-II trial in Influenza virus infections in USA and Mexico [3] Updated 16 Aug 2011
12 Nov 2010 Scientific Update Pharmacodynamics data from a preclinical trial released by NexBio [4] Updated 15 Nov 2010
29 Jul 2010 Phase Change - I Phase-I clinical trials in Influenza virus infections (prevention in patients with well-controlled asthma or bronchiectasis) in USA (Inhalation) Updated 25 Aug 2010
01 Jul 2010 Trial Update Ansun Biopharma and National Institutes of Health initiates a phase I safety trial in patients with Asthma and Bronchiectasis (In adults) in USA (NCT01113034) Updated 03 Apr 2019
18 Jun 2010 Scientific Update Preclinical pharmacodynamics released by NexBio [41] Updated 21 Jun 2010
03 May 2010 Scientific Update Adverse events data from two phase I trials in healthy volunteers released by NexBio [42] Updated 05 May 2010
08 Jan 2010 Phase Change - II Phase-II clinical trials in Influenza virus infections in USA (Inhalation) Updated 13 Jan 2010
08 Jan 2010 Phase Change - II Phase-II clinical trials in Influenza-A virus H1N1 subtype in USA (Inhalation) Updated 13 Jan 2010
31 Dec 2009 Trial Update NexBio completes a Phase-I trial [NCT00876161] in healthy volunteers in USA Updated 27 Aug 2010
10 Nov 2009 Phase Change - Preclinical Preclinical trials in Asthma in USA (PO) Updated 11 Nov 2009
06 Nov 2009 Scientific Update Pharmacodynamics data from a preclinical trial in Influenza virus infections released by NexBio [43] Updated 10 Nov 2009
15 Sep 2009 Scientific Update Pharmacodynamics data from a preclinical trial in Influenza virus infections presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC-2009) [25] , [24] Updated 22 Sep 2009
25 Aug 2009 Phase Change - Preclinical Preclinical trials in Parainfluenza virus infections in USA (Inhalation) Updated 28 Aug 2009
25 Aug 2009 Scientific Update Pharmacodynamics data from a preclinical trials in Influenza-A virus H5N1 subtype released by NexBio [21] Updated 28 Aug 2009
31 Dec 2008 Trial Update NexBio completes a phase I trial in Influenza virus infections in the USA Updated 20 Jan 2009
31 Oct 2007 Phase Change - I Phase-I clinical trials in Influenza virus infections treatment in USA (PO) Updated 15 Nov 2007
23 Aug 2004 Licensing Status DAS 181 is available for licensing as of 23 Aug 2004. http://www.nexbio.com Updated 15 Nov 2010
23 Aug 2004 Licensing Status DAS 181 is available for licensing (http://www.nexbio.com) Updated 03 Sep 2004
23 Aug 2004 Phase Change - Preclinical Preclinical trials in Influenza virus infections treatment in USA (Inhalation) Updated 03 Sep 2004

References

  1. NexBio Receives a $6 Million NIH SBIR Grant for the Clinical Development of a Novel Influenza Medicine.

    Media Release
  2. NexBio′s DAS181 (Fludase *) Improves Symptoms in Four Severely Immunocompromised Patients With Life-Threatening Parainfluenza Pneumonitis.

    Media Release
  3. NexBio Reports Safety and Significant Antiviral Activities of DAS181 (Fludase)* from a Dose-Ranging Phase II Clinical Trial.

    Media Release
  4. NexBio Presents Data at ACAAI 2010 Demonstrating Mechanism of Action for Improvement in Airway Function by DAS181 (Fludase *).

    Media Release
  5. NexBio(R) Presents Data Showing Anti-Asthma Activity of DAS181 (Fludase(R)*) at ACAAI 2009.

    Media Release
  6. Ansun Biopharma Enrolls First Patient in Proof of Concept Trial of DAS181 for the Treatment of COVID-19.

    Media Release
  7. Ansun Biopharma Announces Positive Results from Investigator-Initiated Trial of Novel COVID-19 Treatment.

    Media Release
  8. DAS181 for COVID-19: A Phase II/III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

    ctiprofile
  9. DAS181 for Severe COVID-19: Compassionate Use

    ctiprofile
  10. China's NMPA Approves Two Separate INDs On The Same Day For Ansun's Investigational Biologic Compound DAS181.

    Media Release
  11. A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

    ctiprofile
  12. Randomized, Double-blind, Placebo-controlled Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza.

    ctiprofile
  13. Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza.

    ctiprofile
  14. NexBio Initiates Phase II Trial of DAS181 (Fludase(R)*) for Treatment of Influenza, Including Pandemic Influenza A(H1N1).

    Media Release
  15. Ansun BioPharma Publishes Effects of FluDase(Tm) on Drug Resistant Flu.

    Media Release
  16. A Phase I C Clinical Study With Influenza Antiviral DAS181-F03: Double-Blind, Randomized, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study in Healthy Adults.

    ctiprofile
  17. A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181 (Fludase) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis.

    ctiprofile
  18. NexBio Completes First-in-Man Clinical Trial With DAS181 (Fludase(R)) and Strengthens Clinical Leadership.

    Media Release
  19. Study 181-1-06-01 - phase 1A clinical study with DAS181: Double-blind, randomized, placebo-controlled, single dose escalating study in healthy adults

    ctiprofile
  20. Phase 1 Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study in Healthy Adults

    ctiprofile
  21. NexBio(R) Demonstrates DAS181 (Fludase(R)*), a Broad-Spectrum Drug Candidate, Inhibits Influenza Viral Infection in Human Lung Tissue.

    Media Release
  22. NexBio(R) Publishes Preclinical Study Showing DAS181 (Fludase(R)*) Anti-Influenza Therapy Protects Against Secondary Bacterial Pneumonia.

    Media Release
  23. NexBio(R) Presents DAS181 (Fludase(R)*) Potently Inhibits Novel Swine-Origin A(H1N1) and NAI-Resistant Influenza Viruses, at ICAAC 2009.

    Media Release
  24. Moss RB. In Vivo and In Vitro Activity of DAS181 against NAI-Resistant Influenza Virus. 49th-ICAAC 2009; abstr. V-1070.

    Available from: URL: http://www.icaac.org
  25. Triana-Baltzer G B. Late-Breaker Abstract Pandemic H1N1 2009 and Drug Resistant Influenza Viruses are Potently Inhibited by DAS181, a Sialidase Fusion Protein. 49th-ICAAC 2009; abstr. V-1074c.

    Available from: URL: http://www.icaac.org
  26. Ansun BioPharma Announces Breakthrough Designation for its Experimental Drug DAS181.

    Media Release
  27. Ansun BioPharma Announces Two Publications Showing Inhibitory Effects of DAS181 on Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV).

    Media Release
  28. Investigation of Ansun Biopharma Dismissed, Company Continues Development of Therapies for Severe Respiratory Infections.

    Media Release
  29. Ansun Biopharma Announces First Patient Enrolled In Phase 3 Clinical Trial Evaluating DAS181 In Hospitalized, Immunocompromised Patients With Lower Respiratory Tract Parainfluenza Virus Infection.

    Media Release
  30. A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

    ctiprofile
  31. An Open Label Study to Examine the Effects of DAS181 Administered by Dry Powder Inhaler (DPI) or Nebulized Formulation in Immunocompromised Subjects With Parainfluenza (PIV) Infection

    ctiprofile
  32. Chemaly RF, Moss R, Marty FM, Wolfe CR, Lawrence SJ, Dadwal S, et al. A randomized, double-blind, placebo-controlled multicenter phase 2 trial to examine the effects of DAS181 in immunocompromised (IC) patients with parainfluenza virus (PIV) lower respiratory tract infection (LRTI) on supplemental oxygen (SO). IDW-2018 2018; abstr. 1715.

    Available from: URL: https://idsa.confex.com/idsa/2018/webprogram/Paper73453.html
  33. A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen

    ctiprofile
  34. Ansun BioPharma Announces Successful Treatment with DAS181 in A Patient with Severe Influenza and Parainfluenza at IDSA Meeting.

    Media Release
  35. Hurwitz JL, Jones B, Moss R, Sanders RL. V-382 - Inhibition of Clinical Isolates of Human Parainfluenza Virus by DAS181 in Cell Culture and in a Cotton Rat Model. 52nd-ICAAC-2012 2012; abstr. V-382.

    Available from: URL: http://www.abstractsonline.com/plan/ViewAbstract.aspx?mID=2963&sKey=889bb5de-8f88-44a6-add7-894a35a141a2&cKey=217c3718-133c-4920-a428-15e965d15b17&mKey=%7b6B114A1D-85A4-4054-A83B-04D8B9B8749F%7d
  36. Ansun BioPharma Announces CDC Publication Showing Potent Inhibitory Effects of DAS181 on Enterovirus68.

    Media Release
  37. Ansun BioPharma Announces Late Breaker Oral Presentation at ICAAC on the Clinical Activity of ParaDase(Tm), an Investigational Drug for the Treatment of Severe Parainfluenza Infection.

    Media Release
  38. Ansun BioPharma Announces Potent in-vitro DAS181 Activity against Respiratory Syncytial Virus at 5th Congress of Virology.

    Media Release
  39. Ansun BioPharma secures $85 million in Series A Financing.

    Media Release
  40. NexBio Granted United States Patent Covering DAS181 (Fludase(R) *) and its Use for Prevention and Treatment of Influenza and Parainfluenza.

    Media Release
  41. NexBio(R) and Weill Cornell Medical College Publish Preclinical Study Showing DAS181 (Fludase(R)*) Anti-Influenza Drug Inhibits Parainfluenza Virus.

    Media Release
  42. Clinical Trial of DAS181 (Fludase(R)*) in Asthmatics Initiated at the National Institutes of Health.

    Media Release
  43. NexBio(R) Publishes Two Articles Showing DAS181 (Fludase(R)*) Potently Inhibits Pandemic Influenza A(H1N1) and NAI-Resistant Influenza Viruses.

    Media Release
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