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Brilacidin coronavirus vaccine - Innovation Pharmaceuticals

Drug Profile

Brilacidin coronavirus vaccine - Innovation Pharmaceuticals

Alternative Names: COVID-19 vaccine - Innovation Pharmaceuticals

Latest Information Update: 26 May 2020

At a glance

  • Originator Innovation Pharmaceuticals
  • Developer Innovation Pharmaceuticals; University of Pennsylvania
  • Class Viral vaccines
  • Mechanism of Action Immunostimulants; Type 4 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Discontinued COVID 2019 infections

Most Recent Events

  • 19 May 2020 Discontinued - Preclinical for COVID-2019 infections (Prevention) in USA (IV)
  • 06 Apr 2020 Innovation Pharmaceuticals plans a clinical trial for COVID-2019 infections in the US and Europe
  • 17 Mar 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (IV)

Development Overview

Introduction

Brilacidin is a first-in class defensin biomimetic, that was being developed as a coronavirus (COVID-19) vaccine by Innovation Pharmaceuticals for the treatment of COVID-2019 infections. Vaccines containing defensins as adjuvants activate the primary innate antiviral immune response as well as mediate other immunomodulatory activities against a number of viruses, including the coronaviruses. Brilacidin acts by bolstering the body's natural immune response and inhibiting type-4-cyclic-nucleotide-phosphodiesterase-inhibitors (PDE4/PDE3) thereby disrupting viral replication and enhancing the protective role of natural surfactants in the lung and helping resolve respiratory problems common to the coronavirusis. The company intends to develop administer the candidate as a monotherapy or as an adjuvant therapy with other antivirals. The underlying theory is that once the viral load is reduced, the body’s natural immune response possibly strengthened by brilacidin administered post-infection as an adjuvant therapy should be better able to fight off coronavirus complications. Preclinical development was underway in the US however, the development is discontinued.

As of May 2020, Innovation Pharmaceuticals announced that brilacidin as a vaccine would not be studied further . While the vaccine pathway remains of interest, the Company is prioritising brilacidin’s clinical development as a potential small molecule drug for COVID-2019 infections [See Adis Insight Drug Profile800028651].

Key Development Milestones

As of May 2020, Innovation Pharmaceuticals announced that brilacidin as a vaccine would not be studied further and the development was discontinued. While the vaccine pathway remains of interest, the Company is prioritising brilacidin’s clinical development as a potential small molecule drug for COVID-2019 infections [See Adis Insight Drug Profile800028651] [1] .

As of March 2020, in research studies conducted by the University of Pennsylvania, brilacidin vaccine demonstrated potent activity against various clinical isolates of gram postive and negative pathogens as well as enveloped viruses like coronavirus. The drug inhibited PDE4/PDE3 in preclinical tests. It also inhibited higher levels of pro-inflammatory cytokines commonly exhibited by patients affected with COVID-2019 infections [2] [3] .

In March 2020, Innovation Pharmaceuticals submitted preliminary summary of brilacidin's potential as a novel coronavirus treatment to the Biomedical Advanced Research and Development Authority (BARDA), which is dedicated to rapidly identifying and funding medical countermeasures to the COVID-19 outbreak [4] [5] .

Drug Properties & Chemical Synopsis

  • Route of administration IV
  • Formulation unspecified
  • Class Viral vaccines
  • Target Type 4 cyclic nucleotide phosphodiesterase
  • Mechanism of Action Immunostimulants; Type 4 cyclic nucleotide phosphodiesterase inhibitors
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Discontinued (Preclinical) USA IV / unspecified Innovation Pharmaceuticals, University of Pennsylvania 19 May 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Innovation Pharmaceuticals Originator USA
Innovation Pharmaceuticals Owner USA
University of Pennsylvania Collaborator USA

Development History

Event Date Update Type Comment
19 May 2020 Phase Change - Discontinued(Preclinical) Discontinued - Preclinical for COVID-2019 infections (Prevention) in USA (IV) [1] Updated 26 May 2020
06 Apr 2020 Trial Update Innovation Pharmaceuticals plans a clinical trial for COVID-2019 infections in the US and Europe Updated 14 Apr 2020
17 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (IV) [2] Updated 02 Apr 2020
24 Feb 2020 Regulatory Status Innovation Pharmaceuticals submits preliminary summary of brilacidin's potential for COVID-2019-infections to the Biomedical Advanced Research and Development Authority (BARDA) [5] Updated 02 Apr 2020

References

  1. Innovation Pharmaceuticals Brilacidin Reduces Viral Titer of SARS-CoV-2 (COVID-19) by 75 percent After Only 1 Hour of Preincubation in In Vitro Study at BSL-3 Facility; Demonstrates Potent and Rapid Virucidal Activity.

    Media Release
  2. Innovation Pharmaceuticals Brilacidin to be Researched as Possible Novel Coronavirus (COVID-19) Vaccine; Brilacidin Now Being Tested as Drug and Vaccine at Different Institutions.

    Media Release
  3. Innovation Pharmaceuticals Provides Scientific Rationale and Clinical Development Perspectives for Brilacidin as a Potential Novel Coronavirus COVID-19 Treatment.

    Media Release
  4. Innovation Pharmaceuticals Submits Material Transfer Agreement to Study Lead Defensin Mimetic Brilacidin for Coronavirus (COVID-19).

    Media Release
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