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AT 100

Drug Profile

AT 100

Alternative Names: AT-100; rhSP-D

Latest Information Update: 27 May 2020

At a glance

  • Originator Airway Therapeutics
  • Class Recombinant proteins
  • Mechanism of Action Cell membrane permeability enhancers; Protein replacements
  • Orphan Drug Status

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

    Yes - Bronchopulmonary dysplasia
  • New Molecular Entity Yes

Highest Development Phases

  • Preclinical Bronchopulmonary dysplasia
  • Research COVID 2019 infections

Most Recent Events

  • 20 May 2020 Airway Therapeutics expects to file an Investigational New Drug application (IND) to the US FDA for Bronchopulmonary dysplasia in the third quarter of 2020
  • 20 May 2020 Airway Therapeutics files an pre-IND application with the US FDA for Bronchopulmonary dysplasia (BPD) before May 2020
  • 20 May 2020 Airway Therapeutics plans clinical trial in Bronchopulmonary dysplasia (In infants) in late 2020

Development Overview

Introduction

AT 100 is a recombinant human surfactant protein D (rhSP-D), being developed by Airway Therapeutics, for use with existing surfactants in the prevention of bronchopulmonary dysplasia (BPD) in very premature infants and for the treatment of COVID-2019 infections. Preclinical development in bronchopulmonary dysplasia and early research in COVID-2019 infections is ongoing in the US.

Airway Therapeutics intends to develop rhSP-D, in combination with an inhaled surfactant, for the treatment of cystic fibrosis, in the future. Airway Therapeutics expects that the surfactant-rhSP-D combination could be used for the prevention and treatment of neonatal respiratory distress syndrome (nRDS) as well as for the prevention of BPD.

Airway Therapeutics is using Glycotope’s proprietary GlycoExpress® cell line technology to produce recombinant human surfactant protein D (rhSP-D, AT 100). The Glycotope cell line is designed to optimise the manufacturing and give high-yield production of AT 100, with fast production cycles.

Company Agreements

In May 2020, Airway Therapeutics entered into a manufacturing agreement with Celonic Group to produce human recombinant protein AT 100 (rhSP-D) as a therapeutic candidate against COVID-19. As pert the agreement terms, Celonic will be responsible for process optimisation and GMP manufacturing of AT 100 for clinical study. [1]

In September 2017, Airway Therapeutics entered into an exclusive licensing agreement with Glycotope. Under the terms of the agreement, Airway received worldwide commercial rights to use Glycotope's proprietary cell line technology, GlycoExpress®, to produce recombinant human surfactant protein D (rhSP-D, AT 100). The Glycotope cell lines will be used for high-yield production of recombinant human surfactant protein D, to provide human glycosylation patterns on the final protein product, and will serve as the basis for the production of the protein for human use. [2]

Airway Therapeutics was formed in June 2011 to develop newer surfactant products based on the research conducted by at Cincinnati Children's Hospital Medical Center. CincyTech and Cincinnati Children's Tomorrow Fund have each invested $US250 000 in the company. The investments are part of a projected $US1.2 million seed-stage funding round led by CincyTech [3] .

Key Development Milestones

Prior May 2020, Airway Therapeutics filed a pre-IND submission with the US FDA for AT 100 as a preventive treatment for bronchopulmonary dysplasia (BPD) in very preterm infants [1] .

In March 2020, Airway Therapeutics announced filling with the Respiratory Diseases Branch of the National Institutes of Health (NIH) to evaluate AT 100, for the treatment of COVID-19 infection [4] .

In March 2017, Airway Therapeutics announced its intention to file an investigational new drug application to initiate a clinical proof of concept trial of AT 100 in bronchopulmonary dysplasia and in other lung related disorders [5] . An IND for AT 100 in combination with an existing surfactant was expected to be filed with the FDA in the fourth quarter of 2012. The company was in discussion with one of a surfactant manufacturer as of June 2011 [3] .

Preclinical data suggested that AT 100, in addition to commercially available surfactant, effectively prevents the infection, reduces inflammation and lung damage compared to current standard of care [6] . AT 100 also modulates immune system [7] .

The US FDA and the EMA granted orphan drug designation to AT 100 for the prevention of bronchopulmonary dysplasia [6] .

Financing information

In January 2020, Airway Therapeutics received a oversubscribed series C financing worth $US 15.5 million, the proceeds of which will be used for the clinical development of AT 100 for the preventive treatment of serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants, while also supporting preclinical research in influenza, respiratory syncytial virus (RSV) and cystic fibrosis. The funding will also enable further development its preclinical package for influenza, RSV and cystic fibrosis [7] .

In March 2017, Airway Therapeutics received a funding of $US6.3 million as a part of bridge financing from new and existing investors including Cincinnati Children’s Hospital Medical Center, CincyTech and Queen City Angels. The company plans to utilise the funds for the development of AT 100 which includes, manufacturing, IND enabling studies and clinical proof of concept trials [5] .

In September 2014, Airway Therapeutics secured $US4.6 million in Series A financing. The company will use proceeds for the development of AT 100, including formulation, manufacturing and designing preclinical studies required in preparation for clinical studies [6] .

Patent Information

Airway Therapeutics has patent protection for AT 100 used for the prevention of bronchopulmonary dysplasia [5] .

Drug Properties & Chemical Synopsis

  • Route of administration Intratracheal
  • Formulation unspecified
  • Class Recombinant proteins
  • Target Protein
  • Mechanism of Action Cell membrane permeability enhancers; Protein replacements
  • WHO ATC code

    R07A-A (Lung surfactants)

  • EPhMRA code

    R7C (Lung Surfactants)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Bronchopulmonary dysplasia - Prevention Preclinical USA Intratracheal / unspecified Airway Therapeutics 16 Jul 2016
COVID 2019 infections - - Research USA unspecified / unspecified Airway Therapeutics 12 Mar 2020

Orphan Status

Indication Patient Segment Country Organisation Event Date
Bronchopulmonary dysplasia Prevention European Union Airway Therapeutics 10 Sep 2014
Bronchopulmonary dysplasia Prevention USA Airway Therapeutics 10 Sep 2014

Commercial Information

Involved Organisations

Organisation Involvement Countries
Airway Therapeutics Originator USA
Airway Therapeutics Owner USA
Glycotope Technology Provider Germany

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Trial Update Airway Therapeutics plans clinical trial in Bronchopulmonary dysplasia (In infants) in late 2020 (700322173) [1] 27 May 2020
30 Sep 2020 Regulatory Status Airway Therapeutics expects to file an Investigational New Drug application (IND) to the US FDA for Bronchopulmonary dysplasia in the third quarter of 2020 [1] 27 May 2020

Development History

Event Date Update Type Comment
20 May 2020 Regulatory Status Airway Therapeutics expects to file an Investigational New Drug application (IND) to the US FDA for Bronchopulmonary dysplasia in the third quarter of 2020 [1] Updated 27 May 2020
20 May 2020 Regulatory Status Airway Therapeutics files an pre-IND application with the US FDA for Bronchopulmonary dysplasia (BPD) before May 2020 [1] Updated 27 May 2020
20 May 2020 Trial Update Airway Therapeutics plans clinical trial in Bronchopulmonary dysplasia (In infants) in late 2020 [1] Updated 27 May 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (unspecified route) [4] Updated 17 Mar 2020
11 Sep 2017 Licensing Status Airway Therapeutics in-licenses GlycoExpress cell line technology from Glycotope [2] Updated 19 Sep 2017
07 Mar 2017 Active Status Review Research programme: recombinant human surfactant protein D is still in preclinical development for Bronchopulmonary dysplasia (Prevention) in USA [5] Updated 08 Mar 2017
07 Mar 2017 Patent Information Airway Therapeutics has patent protection for AT 100 for Bronchopulmonary dysplasia [5] Updated 08 Mar 2017
07 Mar 2017 Regulatory Status Airway Therapeutics announces intention to submit IND to US FDA for Bronchopulmonary dysplasia (Prevention) [5] Updated 08 Mar 2017
07 Mar 2017 Trial Update Airway Therapeutics plans a clinical trial for Bronchopulmonary dysplasia (Prevention) [5] Updated 08 Mar 2017
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Bronchopulmonary-dysplasia in USA (Intratracheal) Updated 16 Jul 2016
10 Sep 2014 Regulatory Status AT 100 receives Orphan Drug status for Bronchopulmonary dysplasia (Prevention) in USA Updated 19 Sep 2014
10 Sep 2014 Regulatory Status AT 100 receives Orphan Drug status for Bronchopulmonary dysplasia (Prevention) in European Union Updated 19 Sep 2014
03 Jun 2011 Phase Change - Preclinical Preclinical trials in Bronchopulmonary dysplasia in USA (Intratracheal) Updated 13 Jun 2011

References

  1. Airway Therapeutics and Celonic Group Collaborate to Produce AT-100 as Promising New Candidate for Coronavirus.

    Media Release
  2. Airway Therapeutics, LLC Obtains License on Glycotope Cell Line.

    Media Release
  3. New Company Formed to Take Cincinnati Children's Lung Treatment Research to Premature Babies.

    Media Release
  4. Airway Therapeutics Announces Filing with NIH to Evaluate AT-100 as a Therapy for Novel Coronavirus.

    Media Release
  5. Airway Therapeutics Closes $6.3M in Finance Round.

    Media Release
  6. Airway Therapeutics Raises $4.6 Million in Series A Funding.

    Media Release
  7. Airway Therapeutics Closes $15.5 Million Series C Financing to Advance Preclinical and Clinical Research and Development Programs to Prevent and Treat Serious Respiratory Diseases.

    Media Release
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