Alunacedase alfa - Apeiron Biologics
Alternative Names: APN-01; GSK-2586881; Recombinant-human-soluble-angiotensin-converting-enzyme-2-Apeiron-Biologics; rhACE2; rhACE2-Apeiron-BiologicsLatest Information Update: 05 Nov 2023
At a glance
- Originator Apeiron Biologics
- Developer Apeiron Biologics; GlaxoSmithKline; University of British Columbia
- Class Anti-ischaemics; Antihypertensives; Antineoplastics; Antivirals; Cardiovascular therapies; Heart failure therapies; Recombinant proteins
- Mechanism of Action ACE stimulants; Virus internalisation inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Phase II Acute lung injury; Adult respiratory distress syndrome; COVID 2019 infections; Pulmonary arterial hypertension
- Discontinued Cancer; Diabetic nephropathies; Heart failure; Hypertension; Myocardial infarction
Most Recent Events
- 03 Nov 2022 Alunacedase alfa - Apeiron Biologics is available for licensing as of 03 Nov 2022. https://www.invios.com/
- 03 Nov 2022 Adverse events and pharmacodynamics data from a phase I trial in COVID-2019 infections (In volunteers) released by APEIRON Respiratory Therapies
- 27 May 2022 Apeiron Biologics completes a phase I trial in COVID-2019 infections (In volunteers) in Austria (Inhalation) (NCT05065645)
Development Overview
Introduction
Alunacedase alfa, designated as APN 01, is a recombinant human angiotensin converting enzyme 2 (rhACE2), being developed by AResT (a wholly owned subsidiary of invIOs) which was in-licensed from Apeiron Biologics, for the treatment of acute lung injury, adult respiratory distress syndrome, pulmonary arterial hypertension, and COVID-2019 infections. ACE2 acts on the vasoconstrictor peptide angiotensin II (ANG II) and other substrates and is the only active homologue of ACE. The ACE enzyme is also used by viruses to enter the cell. The virus binds to soluble ACE2/APN01, instead of ACE2 on the cell surface, thus rendering the virus incapable to cause infections. APN 01 showed dual action with its enzyme function, by blocking the viral spike glycoprotein and by protecting the lung, blood vessels or the heart from injury. Clinical development is underway in the US, Canada and Europe.
Alunacedase alfa was being developed by APEIRON Biologics, however in April 2022, AResT (APEIRON Respiratory Therapies), was demerged from APEIRON Biologics to continue the development of alunacedase alfa [1]
Alunacedase alfa was licensed out to GlaxoSmithKline, however GlaxoSmithKline decided not to pursue the further development. Apeiron previously evaluated the compound as a treatment for cancer, cardiovascular diseases (including hypertension, heart failure and myocardial infarction), and diabetic kidney diseases (including diabetic nephropathies). However, development has been discontinued in these indications.
Phase I development in acute lung injury/adult respiratory distress syndrome was conducted in Germany. As at June 2020, no recent reports of development were identified.
As of November 2022, AResT is actively exploring strategic out-licensing/partnership opportunities for the development of alunacedase alfa [1]
Company Agreements
In 2019, Apeiron Biologics obtained the APN 01 licenses back from GlaxoSmithKline (now GSK) for further clinical development, after a strategic refocusing of GSK to oncology. Apeiron currently has the full licenses, clinical data and protocol from GSK, GMP production technology and stored GMP grade rhACE2 available for immediate use in trials in China. In February 2010, Apeiron Biologics AG (Apeiron) signed an agreement granting GlaxoSmithKline (GSK) exclusive rights to APN01 (recombinant human Angiotensin Converting Enzyme 2, rhACE2), an enzyme biotherapeutic currently in phase 1 development for the treatment of the acute respiratory distress syndrome (ARDS). Under the terms of the agreement, the total milestone payments could reach £207 million (approx. €236 million) in the event of launch in multiple indications. Apeiron will receive an up-front payment of £11 million (approx. €12.5 million) in cash and equity investment and will receive royalties on net sales.
This deal value was converted from £ at a rate of $US1.595 dated 2 February 2010. [2] [3]
In April 2022, APEIRON Biologics announced the demerger of invIOs and APEIRON Respiratory Therapies (AResT). invIOs will continue to focus on developing novel immuno-oncology treatments for difficult-to-treat cancers with its cell therapy platform EPiC (Enhancement Platform for immune Cells) and clinical-stage lead asset, APN401. AResT will drive the development of APN01, currently being developed for the treatment of COVID-19 and other respiratory and pulmonary indications. [4]
Key Development Milestones
COVID-19 infections
In July 2021, APEIRON Biologics announced that alunacedase alfa was selected for a publicly funded, large-scale study in COVID-19 by the US government based on promising results from the phase II trial [see below]. The trial is scheduled to start in Q3 2021 [5] .
In December 2020, APEIRON Biologics completed a phase II trial (APN01-01COVID19) that assessed safety and tolerability of alunacedase alfa in patients with COVID-2019 infections (EudraCT2020-001172-15; NCT04335136). The randomised, double-blind trial was initiated in April 2020 and enrolled 178 patients in Austria, Germany, Denmark, Russia and the UK. In September 2020, the company released results of the first patient treated with alunacedase alfa in named patient use [6] [7] [8] . In March 2021, Efficacy, safety and pharmacodynamic data from the trial were released by APEIRON Biologics [9] .
The phase I trial met all primary and secondary endpoints, with all results indicating that the inhalation of alunacedase alfa at all dosage levels used in the trial is safe and well tolerated. In May 2022, APEIRON Biologics completed a phase I trial which was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of inhaled alunacedase alfa for the treatment of COIVID-2019 infections (APN01-01INHAL; NCT05065645). The double-blind, randomized trial was initiated in October 2021 and enrolled 40 healthy volunteers in Austria [10] [11] . In November 2022, positive data from the trial was released by APEIRON Respiratory Therapies [1] .
In March 2020, Apeiron Biologics withdrew an investigator-initiated clinical trial prior to enrollment, as there was no CDE Approval. The randomised, open label, controlled trial was initiated in February 2020, and designed to evaluate alunacedase alfa in adult patients with severe COVID-19 infections in China (GIRH-APN01; NCT04287686) [12] . Data from the study was planned to support a potential phase IIb study in larger patient population [3] .
Acute lung injury or adult respiratory distress syndrome
In October 2014, GlaxoSmithKline completed a phase IIa trial in the US and Canada, which evaluated the tolerability, safety, pharmacokinetics and pharmacodynamics of GSK 2586881 in 44 patients with acute respiratory distress syndrome or acute lung injury, in October 2014 (NCT01597635; 114622). The trial was initiated in September 2012 and was conducted in two parts; an open-label phase and a double-blind, placebo-controlled phase [13] [14] .
Discontinued indications
In 2019, APEIRON obtained the licenses related to alunacedase alfa back from GlaxoSmithKline (GSK) for further clinical development, after a strategic refocusing of GSK to oncology. As per APEIRONs' pipeline alunacedase alfa is still in phase II development for acute lung injury and pulmonal arterial hypertension [3] .
As at July 2019, GlaxoSmithKline decided to discontinue the development of GSK 2586881(GlaxoSmithKline pipeline July 2019).
In May 2019, GlaxoSmithKline completed a phase IIa dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK 2586881 in patients with pulmonary arterial hypertension (206246; NCT03177603; EudraCT2017-000212-41). The open-label, parallel trial initiated in February 2018 and enrolled 23 patients in Spain, Germany and USA [15] .
In January 2019, GlaxoSmithKline terminated a phase I trial due to technical feasibility, operational considerations and futility in line with pre-specified criteria, that was designed to evaluate the effect of a single IV dose of GSK 2586881 on the acute hypoxic pulmonary vasoconstriction response, in healthy volunteers (204987; NCT03000686). The single-centre, randomised, crossover, placebo-controlled, double-blind trial intended to enrol approximately 25 volunteers in Germany [16] .
In December 2009, Apeiron completed a phase I trial of GSK 2586881 in 22 healthy volunteers in Switzerland (NCT00886353; APN01-1-01). The trial determined the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple intravenous doses of GSK 2586881. In the single dose, dose escalation part, four cohorts received GSK 2586881 (100, 200, 400 or 800 µg/kg) or placebo. In the multiple dose part, two cohorts received three and six administrations of GSK 2586881 daily, respectively; the planned dosage was 400 µg/kg. Study results showed GSK 2586881 to be safe; no side effects or toxicities were found [17] [18] .
In an ex vivo study, treatment with GSK 2586881 of undiluted heparinised plasma samples or effusions of patients with cancer resulted in the reduction of elevated angiotensin II. Apeiron filed for an application to initiate a clinical trial of GSK 2586881 in patients with advanced cancer; however, no recent development has been reported for this indication [17] .
Promising data from GSK 2586881 in murine models of hypertension were presented at the 18th European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension Sessions (HYP-2008) [19] . However, no recent development has been reported for this indication.
Financing information
In June 2020, APEIRON Biologics AG completed a financing round totaling EUR 17.5 million, thus securing the further development of its drug candidate APN 01 for the treatment of COVID-19 patients and the further development of immuno-oncology projects [20] .
Drug Properties & Chemical Synopsis
- Route of administration Inhalation, IV
- Formulation Infusion, Liquid, unspecified
- Class Anti-ischaemics, Antihypertensives, Antineoplastics, Antivirals, Cardiovascular therapies, Heart failure therapies, Recombinant proteins
- Target ACE; Coronavirus spike glycoprotein; Virus internalisation
- Mechanism of Action ACE stimulants; Virus internalisation inhibitors
-
WHO ATC code
A10X (Other Drugs Used in Diabetes)
C01 (Cardiac Therapy)
C02 (Antihypertensives)
J05A-X (Other antivirals)
L01 (Antineoplastic Agents)
R07A (Other Respiratory System Products)
-
EPhMRA code
A10X (Other Drugs Used in Diabetes)
C1 (Cardiac Therapy)
C2 (Antihypertensives)
J5B9 (Antivirals, others)
L1 (Antineoplastics)
R7 (Other Respiratory System Products)
- CAS Registry Number 2416824-55-8
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
acute lung injury |
Eligibility Criteria |
carboxypeptidase B1 |
|
|
acute lung injury |
Outcome Measure |
Surfactant protein D Renin RAS RAGE pro-melanin concentrating hormone MPO L-Aspartic acid Interleukin-8 (IL-8) Interleukin-6 (IL-6) hydroxysteroid (17-beta) dehydrogenase 4 group-specific component (vitamin D binding protein) D-box binding PAR bZIP transcription factor Creatinine carboxypeptidase B1 C-reactive protein (CRP) Angiotensin II Angiopoietin 2 (ANGPT2) Alkaline phosphatase (ALPL) Aldosterone ACE2 |
|
|
cOVID 2019 infections |
Outcome Measure |
Von Willebrand factor Tumor necrosis factor alpha (TNF-alpha) TNFRSF1B Surfactant protein D serpin family B member 2 Renin RAGE PAI-1 Interleukin-8 (IL-8) Interleukin-6 (IL-6) C-reactive protein (CRP) Angiotensin-converting enzyme (ACE Angiotensin II Angiopoietin 2 (ANGPT2) Aldosterone ACE2 |
|
|
cOVID 2019 infections |
Brief Title |
ACE2 |
|
|
cOVID 2019 infections |
Arm Group Description |
ACE2 |
|
|
cOVID 2019 infections |
Eligibility Criteria |
FSH |
|
|
cOVID 2019 infections |
Official Title |
ACE2 |
|
|
COVID-19 respiratory infection |
Arm Group Description |
ACE2 |
|
|
COVID-19 respiratory infection |
Brief Title |
ACE2 |
|
|
COVID-19 respiratory infection |
Official Title |
ACE2 |
|
|
COVID-19 respiratory infection |
Outcome Measure |
D-dimer C-reactive protein (CRP) |
|
|
diabetic nephropathies |
Brief Title |
ACE2 |
|
|
diabetic nephropathies |
Eligibility Criteria |
L-Aspartic acid Alkaline phosphatase (ALPL) |
|
|
diabetic nephropathies |
Official Title |
ACE2 |
|
|
diabetic nephropathies |
Outcome Measure |
Angiotensinogen (AGT Angiotensin II |
|
|
heart failure |
Brief Title |
ACE2 |
|
|
heart failure |
Eligibility Criteria |
L-Aspartic acid Alkaline phosphatase (ALPL) |
|
|
heart failure |
Official Title |
ACE2 |
|
|
heart failure |
Outcome Measure |
Angiotensinogen (AGT Angiotensin II |
|
|
hypertension |
Outcome Measure |
Angiotensinogen (AGT |
|
|
hypertension |
OutcomeMeasure |
Angiotensin II |
|
|
hypertension |
Brief Title |
ACE2 |
|
|
hypertension |
Eligibility Criteria |
L-Aspartic acid Alkaline phosphatase (ALPL) |
|
|
hypertension |
Official Title |
ACE2 |
|
|
myocardial infarction |
Brief Title |
ACE2 |
|
|
myocardial infarction |
Eligibility Criteria |
L-Aspartic acid Alkaline phosphatase (ALPL) |
|
|
myocardial infarction |
Official Title |
ACE2 |
|
|
myocardial infarction |
Outcome Measure |
Angiotensinogen (AGT Angiotensin II |
|
|
Pulmonary arterial hypertension |
Eligibility Criteria |
carboxypeptidase B1 |
|
|
Pulmonary arterial hypertension |
Outcome Measure |
Renin RAS Nitric Oxide (NO) L-Aspartic acid hydroxysteroid (17-beta) dehydrogenase 4 group-specific component (vitamin D binding protein) D-box binding PAR bZIP transcription factor Cardiac Troponin I carboxypeptidase B1 BNP Angiotensin-converting enzyme (ACE Angiotensin II Alkaline phosphatase (ALPL) ACE2 |
|
|
respiratory distress syndrome |
Eligibility Criteria |
carboxypeptidase B1 |
|
|
respiratory distress syndrome |
Outcome Measure |
Surfactant protein D Renin RAS RAGE pro-melanin concentrating hormone MPO L-Aspartic acid Interleukin-8 (IL-8) Interleukin-6 (IL-6) hydroxysteroid (17-beta) dehydrogenase 4 group-specific component (vitamin D binding protein) D-box binding PAR bZIP transcription factor Creatinine carboxypeptidase B1 C-reactive protein (CRP) Angiotensin II Angiopoietin 2 (ANGPT2) Alkaline phosphatase (ALPL) Aldosterone ACE2 |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Alunacedase alfa - Apeiron Biologics | ACE2 | Arm Group Description, Brief Title, Official Title, Outcome Measure |
| Aldosterone | Official Title, Outcome Measure | |
| Alkaline phosphatase (ALPL) | Eligibility Criteria, Outcome Measure | |
| Angiopoietin 2 (ANGPT2) | Outcome Measure | |
| Angiotensin II | Outcome Measure | |
| Angiotensin-converting enzyme (ACE | Outcome Measure | |
| Angiotensinogen (AGT | Outcome Measure | |
| BNP | Outcome Measure | |
| C-reactive protein (CRP) | Outcome Measure | |
| carboxypeptidase B1 | Eligibility Criteria, Outcome Measure | |
| Cardiac Troponin I | Outcome Measure | |
| Creatinine | Outcome Measure | |
| D-box binding PAR bZIP transcription factor | Outcome Measure | |
| D-dimer | Outcome Measure | |
| FSH | Eligibility Criteria | |
| group-specific component (vitamin D binding protein) | Outcome Measure | |
| hydroxysteroid (17-beta) dehydrogenase 4 | Outcome Measure | |
| Interleukin-6 (IL-6) | Outcome Measure | |
| Interleukin-8 (IL-8) | Outcome Measure | |
| L-Aspartic acid | Eligibility Criteria, Outcome Measure | |
| MPO | Outcome Measure | |
| Nitric Oxide (NO) | Outcome Measure | |
| PAI-1 | Outcome Measure | |
| pro-melanin concentrating hormone | Outcome Measure | |
| RAGE | Outcome Measure | |
| RAS | Outcome Measure | |
| Renin | Official Title, Outcome Measure | |
| serpin family B member 2 | Outcome Measure | |
| Surfactant protein D | Outcome Measure | |
| TNFRSF1B | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure | |
| Von Willebrand factor | Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Acute lung injury | - | - | Phase II | Canada, USA | IV / unspecified | Apeiron Biologics | 27 Feb 2012 |
| Adult respiratory distress syndrome | - | - | Phase II | Canada, USA | IV / unspecified | GlaxoSmithKline | 27 Feb 2012 |
| Adult respiratory distress syndrome | - | In volunteers | No development reported (I) | Germany | IV / unspecified | GlaxoSmithKline | 28 Jun 2020 |
| COVID 2019 infections | - | - | Phase II | Austria, Denmark, Germany, Russia, USA, United Kingdom | IV / Infusion | Apeiron Biologics | 03 Jun 2020 |
| COVID 2019 infections | - | - | Phase II | China | IV / Infusion | Apeiron Biologics, University of British Columbia | 26 Feb 2020 |
| COVID 2019 infections | - | In volunteers | Phase I | Austria | Inhalation / Liquid | Apeiron Biologics | 12 Oct 2021 |
| Cancer | - | In volunteers | Discontinued (I) | Switzerland | IV / unspecified | Apeiron Biologics | 28 Jun 2017 |
| Diabetic nephropathies | - | In volunteers | Discontinued (I) | Switzerland | IV / unspecified | Apeiron Biologics | 28 Jun 2017 |
| Heart failure | - | In volunteers | Discontinued (I) | Switzerland | IV / unspecified | Apeiron Biologics | 28 Jun 2017 |
| Hypertension | - | In volunteers | Discontinued (I) | Switzerland | IV / unspecified | Apeiron Biologics | 28 Jun 2017 |
| Myocardial infarction | - | In volunteers | Discontinued (I) | Switzerland | IV / unspecified | Apeiron Biologics | 28 Jun 2017 |
| Myocardial infarction | - | - | Discontinued (Preclinical) | USA | IV / unspecified | Apeiron Biologics | 28 Jun 2017 |
| Pulmonary arterial hypertension | - | - | Phase II | Germany, Spain, USA | IV / Infusion | Apeiron Biologics | 21 Feb 2018 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Apeiron Biologics | Originator | Austria |
| Apeiron Biologics | Owner | Austria |
| AResT | Licensee | Austria |
| University of British Columbia | Collaborator | Canada |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| AResT | - | Clinical Phase Unknown | - | 03 Nov 2022 |
Credit Suisse Market Status
| Indication | Region | Company | Phase | Expected Launch Year | Probability of Success% | Patent Expiry Year | Expected Generic Entry | Last Update |
|---|---|---|---|---|---|---|---|---|
| Acute Lung Injury | Wrld (50% US) | - | Development Stopped | - | - | - | - | 05 Nov 2023 |
Scientific Summary
Adverse Events
Results from a phase II trial in patients with COVID-2019 infections, showed that treatment with alunacedase alfa was safe and well tolerated and no drug-related severe adverse events were observed [9] [8] .
Phase I
Data from the phase I trial indicated that alunacedase alfa was safe and well tolerated at all dose levels with no dose-dependent toxicities observed. There was no serious adverse events reported, all adverse events were mild to moderate with none above grade 2. No patients withdrew from the trial [1] [11]
Pharmacodynamics
Summary
Results from a phase II trial in patients with COVID-2019 infections showed that treatment with alunacedase alfa reduced plasma levels of Ang II compared to control group. Alunacedase alfa treatment showed increased Ang 1-7 and Ang 1-5 levels while no increase in these anti-inflammatory factors was seen in the placebo group. Suppression of Ang II and increase of Ang 1-7 and Ang 1-5 in addition to the observed reduction in viral RNA load under alunacedase alfa treatment [9] [8] .
After 3 days of infusion, serum ACE 2 activity was increased in mice receiving GSK 2586881 compared with control mice (3.93±0.97 versus 0.69±0.39 RFU/µl/hr). Infusion of ANG II alone increased plasma ANG II levels but when given together with GSK 2586881, ANG II levels decreased to the levels of the placebo-infused controls. This increase in blood pressure associated with ANG II infusion was was not observed in mice infused simultaneously with GSK 2586881 and ANG II (n=7) (139±3.6 mmHg versus 156±6.4) [19] .
Phase I:
Data from the phase I trial of alunacedase alfa in healthy volunteers indicated that no anti-alunacedase alfa antibodies were detected [1] [11]
Therapeutic Trials
Results from a phase II trial in patients with COVID-2019 showed that fewer patients treated with alunacedase alfa (n=9) died or received invasive ventilation compared with placebo (n=12), although statistical significance was not achieved due to the low total number of events. Standard of care improved, resulted in fewer deaths and less use of invasive mechanical ventilation. A reduction in viral RNA load over time was observed in the alunacedase alfa treatment group [9] . Earlier results showed that the first patient treated with alunacedase alfa observed significant clinical improvement with an adaptive immune response. Alunacedase alfa effectively blocked the spike glycoprotein in COVID-19 infection. Alunacedase alfa (soluble ACE2) infusion showed the expected enzymatic activity and modulation of the renin angiotensin system. Alunacedase alfa infusion correlated with a gradual reduction in levels of multiple disease relevant inflammatory mediators over the studied time period. The APN 01 infusion also correlated with a rapid loss of detectable viremia and slightly delayed reduction in viral titers in tracheal samples and nasopharyngeal swaps. Alunacedase alfa infusion was fully compatible with an adaptive immune response and the development of high titers of neutralising antibodies against SARS-CoV-2 [6] [8] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Oct 2021 | Trial Update | Apeiron Biologics plans a phase I trial for COVID-2019 infections (In volunteers, In adults) (Inhalation, Solution) in October 2021, (NCT05065645) | 13 Oct 2021 |
| 30 Sep 2021 | Trial Update | APEIRON Biologics plans a clinical trial for COVID-2019 infections in USA in Q3 2021 [5] | 09 Jul 2021 |
| 07 Aug 2017 | Trial Update | GlaxoSmithKline plans a phase II trial for Pulmonary arterial hypertension in USA (IV, Infusion) (NCT03177603) | 21 Aug 2017 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 05 Nov 2023 | Financial Update | Credit Suisse financial data update Updated 05 Nov 2023 |
| 03 Nov 2022 | Licensing Status | Alunacedase alfa - Apeiron Biologics is available for licensing as of 03 Nov 2022. https://www.invios.com/ [1] Updated 14 Nov 2022 |
| 03 Nov 2022 | Scientific Update | Adverse events and pharmacodynamics data from a phase I trial in COVID-2019 infections (In volunteers) released by APEIRON Respiratory Therapies [1] Updated 09 Nov 2022 |
| 27 May 2022 | Trial Update | Apeiron Biologics completes a phase I trial in COVID-2019 infections (In volunteers) in Austria (Inhalation) (NCT05065645) Updated 06 Oct 2022 |
| 26 Apr 2022 | Company Involvement | Apeiron Biologics demerges to form APEIRON Respiratory Therapies GmbH (AResT) and invIOs GmbH (invIOs) [4] Updated 14 Nov 2022 |
| 17 Nov 2021 | Biomarker Update | Biomarkers information updated Updated 19 Nov 2021 |
| 12 Oct 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in Austria (Inhalation) [10] (NCT05065645) Updated 13 Oct 2021 |
| 04 Oct 2021 | Trial Update | Apeiron Biologics plans a phase I trial for COVID-2019 infections (In volunteers, In adults) (Inhalation, Solution) in October 2021, (NCT05065645) Updated 13 Oct 2021 |
| 06 Jul 2021 | Trial Update | APEIRON Biologics plans a clinical trial for COVID-2019 infections in USA in Q3 2021 [5] Updated 09 Jul 2021 |
| 12 Mar 2021 | Scientific Update | Efficacy, safety and pharmacodynamics data from a phase II trial in COVID-2019 infections released by APEIRON Biologics [9] Updated 17 Mar 2021 |
| 26 Dec 2020 | Trial Update | APEIRON Biologics completes a phase II trial (APN01-01COVID19) for COVID-2019 infections in Austria, Germany, Denmark, Russia and the UK (IV)(NCT04335136) Updated 03 Feb 2021 |
| 24 Sep 2020 | Scientific Update | Interim efficacy data from a phase II trial in COVID-2019 infections released by Apeiron Biologics [6] Updated 29 Sep 2020 |
| 28 Jun 2020 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Adult-respiratory-distress-syndrome(In volunteers) in Germany (IV) Updated 28 Jun 2020 |
| 03 Jun 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections in USA, Russia (IV) [20] Updated 06 Jun 2020 |
| 04 May 2020 | Trial Update | Apeiron Biologics initiates enrolment in a phase II trial for COVID-19 infections in Denmark, Germany and Austria (IV)(NCT04335136) (EudraCT2020-001172-15) Updated 11 May 2020 |
| 03 Apr 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections in United Kingdom (IV) (EudraCT2020-001172-15) Updated 02 Jun 2020 |
| 02 Apr 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections in Denmark, Germany, Austria (IV) (NCT04335136) [7] Updated 06 Apr 2020 |
| 02 Apr 2020 | Regulatory Status | APEIRON Biologics receives regulatory approvals in Austria, Germany and Denmark, for a phase II trial for COVID-2019 infections [7] Updated 06 Apr 2020 |
| 17 Mar 2020 | Trial Update | Apeiron Biologics withdraws a clinical trial for COVID-2019-infections in China, prior to enrollment (NCT04287686) Updated 24 Mar 2020 |
| 26 Feb 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections in China (IV) [3] Updated 02 Jun 2020 |
| 26 Feb 2020 | Licensing Status | APEIRON Biologics obtains its license back from GlaxoSmithKline for APN 01 [3] Updated 28 Feb 2020 |
| 26 Feb 2020 | Trial Update | Apeiron Biologics plans a pilot investigator initiated clinical trial for COVID-2019-infections in China [3] (NCT04287686) Updated 28 Feb 2020 |
| 07 May 2019 | Trial Update | GlaxoSmithKline completes a phase II trial in Pulmonary arterial hypertension in USA, Germany and Spain (NCT03177603) Updated 26 Jun 2019 |
| 25 Jan 2019 | Trial Update | GlaxoSmithKline terminates a phase I trial in Adult respiratory distress syndrome (In volunteers) in Germany due to technical feasibility, operational considerations and futility in line with pre-specified criteria (IV) (NCT03000686) Updated 12 Feb 2019 |
| 04 May 2018 | Trial Update | GlaxoSmithKline re initiates phase I trial in Adult respiratory distress syndrome (In volunteers) in Germany (IV) (NCT03000686) Updated 16 May 2018 |
| 21 Feb 2018 | Phase Change - II | Phase-II clinical trials in Pulmonary arterial hypertension in Germany, USA (IV) (NCT03177603) Updated 26 Jun 2019 |
| 04 Dec 2017 | Trial Update | GlaxoSmithKline terminates phase I trial in Adult respiratory distress syndrome (In volunteers) in Germany, following an interim analysis to conduct a thorough data review (IV) (NCT03000686) Updated 11 Dec 2017 |
| 28 Jun 2017 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Myocardial infarction, Hypertension, Heart failure, Diabetic nephropathies and Cancer (In volunteers) in Switzerland (IV) Updated 28 Jun 2017 |
| 28 Jun 2017 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Myocardial infarction in USA (IV) Updated 28 Jun 2017 |
| 24 May 2017 | Phase Change - II | Phase-II clinical trials in Pulmonary arterial hypertension in Spain (IV) (EudraCT2017-000212-41) Updated 21 Aug 2017 |
| 23 May 2017 | Trial Update | GlaxoSmithKline plans a phase II trial for Pulmonary arterial hypertension in USA (IV, Infusion) (NCT03177603) Updated 21 Aug 2017 |
| 17 May 2017 | Phase Change - I | Phase-I clinical trials in Adult respiratory distress syndrome (In volunteers) in Germany (IV) (NCT03000686) Updated 28 Jun 2017 |
| 22 Dec 2016 | Trial Update | GlaxoSmithKline plans a phase I pharmacodynamics trial in Healthy volunteers in Germany (IV, Infusion) (NCT03000686) Updated 26 Dec 2016 |
| 20 Jul 2015 | Active Status Review | Phase-II development is ongoing for Acute lung injury and Acute respiratory distress syndrome in Canada and USA Updated 20 Jul 2015 |
| 01 Oct 2014 | Trial Update | GlaxoSmithKline completes a phase II clinical trial in Acute lung injury and Acute respiratory distress syndrome in Canada and USA (IV) (NCT01597635) Updated 05 Mar 2015 |
| 29 May 2012 | Phase Change - No development reported(I) | No development reported - Phase-I for Cancer in Switzerland (IV) Updated 29 May 2012 |
| 29 May 2012 | Phase Change - No development reported(I) | No development reported - Phase-I for Diabetic nephropathies in Switzerland (IV) Updated 29 May 2012 |
| 29 May 2012 | Phase Change - No development reported(I) | No development reported - Phase-I for Heart failure in Switzerland (IV) Updated 29 May 2012 |
| 29 May 2012 | Phase Change - No development reported(I) | No development reported - Phase-I for Hypertension in Switzerland (IV) Updated 29 May 2012 |
| 29 May 2012 | Phase Change - No development reported(I) | No development reported - Phase-I for Myocardial infarction in Switzerland (IV) Updated 29 May 2012 |
| 29 May 2012 | Phase Change - No development reported(Preclinical) | No development reported - Preclinical for Myocardial infarction in USA (IV) Updated 29 May 2012 |
| 27 Feb 2012 | Phase Change - II | Phase-II clinical trials in Acute lung injury in Canada (IV) Updated 30 May 2012 |
| 27 Feb 2012 | Phase Change - II | Phase-II clinical trials in Acute lung injury in USA (IV) Updated 30 May 2012 |
| 27 Feb 2012 | Phase Change - II | Phase-II clinical trials in Adult respiratory distress syndrome in Canada (IV) Updated 29 May 2012 |
| 27 Feb 2012 | Phase Change - II | Phase-II clinical trials in Adult respiratory distress syndrome in USA (IV) Updated 29 May 2012 |
| 02 Feb 2010 | Licensing Status | GSK 2586881 licensed to GlaxoSmithKline worldwide [2] Updated 18 Feb 2010 |
| 30 Apr 2009 | Phase Change - I | Phase-I clinical trials in Cancer in Switzerland (IV) Updated 16 Jun 2010 |
| 02 Mar 2009 | Phase Change - I | Phase-I clinical trials in Adult respiratory distress syndrome in Switzerland (IV) Updated 02 Mar 2009 |
| 02 Mar 2009 | Phase Change - I | Phase-I clinical trials in Diabetic nephropathies in Switzerland (IV) Updated 02 Mar 2009 |
| 02 Mar 2009 | Phase Change - I | Phase-I clinical trials in Heart failure in Switzerland (IV) Updated 02 Mar 2009 |
| 02 Mar 2009 | Phase Change - I | Phase-I clinical trials in Hypertension in Switzerland (IV) Updated 02 Mar 2009 |
| 02 Mar 2009 | Phase Change - I | Phase-I clinical trials in Myocardial infarction in Switzerland (IV) Updated 02 Mar 2009 |
| 30 Jun 2008 | Other | The GMP-batch of GSK 2586881 is ready for first clinical trials Updated 02 Mar 2009 |
| 19 Jun 2008 | Phase Change - Preclinical | Preclinical trials in Adult respiratory distress syndrome in Austria (Parenteral) Updated 15 Jul 2008 |
| 19 Jun 2008 | Phase Change - Preclinical | Preclinical trials in Diabetic nephropathies in Austria (Parenteral) Updated 15 Jul 2008 |
| 19 Jun 2008 | Phase Change - Preclinical | Preclinical trials in Heart failure in Austria (Parenteral) Updated 15 Jul 2008 |
| 19 Jun 2008 | Phase Change - Preclinical | Preclinical trials in Hypertension in Austria (Parenteral) Updated 15 Jul 2008 |
| 19 Jun 2008 | Phase Change - Preclinical | Preclinical trials in Myocardial infarction in Austria (Parenteral) Updated 15 Jul 2008 |
| 31 Mar 2008 | Phase Change - Preclinical | Preclinical trials in Adult respiratory distress syndrome in USA (Parenteral) Updated 02 Mar 2009 |
| 31 Mar 2008 | Phase Change - Preclinical | Preclinical trials in Myocardial infarction in USA (Parenteral) Updated 02 Mar 2009 |
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Apeiron and GSK sign an exclusive licence agreement for Apeiron's therapeutic enzyme project APN01.
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APEIRON's respiratory drug product to start pilot clinical trial to treat coronavirus disease COVID-19 in China.
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APEIRON shareholders approve new group structure geared towards enabling innovation and growth.
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APEIRON Biologics launches next clinical trial with innovative cancer therapy APN401.
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