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Research programme: coronavirus therapeutics - NanoViricides

Drug Profile

Research programme: coronavirus therapeutics - NanoViricides

Latest Information Update: 01 Jun 2020

At a glance

  • Originator NanoViricides
  • Class Antivirals
  • 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.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Research COVID 2019 infections

Most Recent Events

  • 20 May 2020 NanoViricides plans to request a pre-IND meeting with the US FDA
  • 20 May 2020 Pharmacodynamics data from a preclinical study in COVID-2019 infections released by NanoViricides
  • 20 May 2020 NanoViricides plans a preclinical studies to evaluate effectiveness, safety and toxicity of coronavirus therapeutics

Development Overview

Introduction

Therapeutics are being developed using nanoviricide® technology, by NanoViricides for the treatment of COVID-2019 infections. Early research is underway in the US.

Nanoviricide particles are created chemically by attaching a ligand molecule that binds to the virus naturally and which is derived from the binding site of its cell surface receptor. This is then attached to a nanomicelle flexible polymer. Even when the virus particle mutates, the binding site does not change significantly, meaning that the effectiveness of the particles is not reduced.

NanoViricides is seeking partners for testing drug candidates for the treatment of COVID-2019 infections [1] .

Key Development Milestones

In May 2020, NanoViricides released pharmacodynamics data from a preclinical study in COVID-2019 infections for five candidates [2] .

In May 2020, NanoViricides reported that it has developed two broad spectrum drug candidates that have demonstrated very high anti-viral effectiveness in cell culture studies against two distinctly different, unrelated coronaviruses that cause human disease, namely human coronavirus NL63 (hCoV-NL63), and hCoV-229E80 [3] .

In April 2020, NanoViricides reported that it selected multiple candidates against COVID-2019, following identification of virus-binding ligands. The polymer backbone was also manufactured in multi-kilogram quantities. Two disparate, low-threat circulating coronaviruses have been developed and expanded for testing of drug candidates. NL63 is one coronavirus, which uses the same ACE2 receptor on human cells as SARS-CoV-2, and is thus relevant for testing [4] .

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • Class Antivirals
  • Target Virus internalisation
  • Mechanism of Action Virus internalisation inhibitors
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research USA unspecified / unspecified NanoViricides 30 Jan 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
NanoViricides Originator USA
NanoViricides Owner USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
NanoViricides - Unspecified - 12 Feb 2020

Scientific Summary

Pharmacodynamics

Pharmacodyanamics data obtained from a preclinical study for five candidates in an animal model infected with hCoV-NL63 (a surrogate for SARS-CoV-2) indicated strong effectiveness of the candidates that is consistent with the effectiveness observed in cell culture studies with hCoV-NL63 and hCoV-229E infection. For the candidates that were most effective, the weight loss observed in females (n=5) was 3.9%, for the least effective was 11.2%, for negative control was 20% and for positive control remdesivir, it was 15.2%. For the candidates that were most effective, the weight loss observed in males (n=5) was 8%, for the least effective was 10.9%, for negative control was 25% and for positive control remdesivir, it was 18.6% [2] .

Development History

Event Date Update Type Comment
20 May 2020 Regulatory Status NanoViricides plans to request a pre-IND meeting with the US FDA [2] Updated 01 Jun 2020
20 May 2020 Scientific Update Pharmacodynamics data from a preclinical study in COVID-2019 infections released by NanoViricides [2] Updated 01 Jun 2020
20 May 2020 Trial Update NanoViricides plans a preclinical studies to evaluate effectiveness, safety and toxicity of coronavirus therapeutics [2] Updated 01 Jun 2020
12 May 2020 Trial Update NanoViricides plans clinical trials for COVID-2019 infections [3] Updated 19 May 2020
12 Feb 2020 Licensing Status Coronavirus therapeutics - NanoViricides is available for licensing as of 12 Feb 2020. http://www.nanoviricides.com/ Updated 12 Feb 2020
30 Jan 2020 Phase Change Early research in COVID-2019-infections in USA (unspecified route) [1] Updated 06 Feb 2020

References

  1. NanoViricides Confirms It Has Been Working On A Treatment For The Novel Wuhan Coronavirus.

    Media Release
  2. Strong Effectiveness of NanoViricides Drug Candidates Observed in an Animal Model of Infection by an ACE2-using Human Coronavirus.

    Media Release
  3. NanoViricides Develops Highly Effective Broad-Spectrum Drug Candidates Against Coronaviruses.

    Media Release
  4. NanoViricides' President Dr. Anil Diwan was Interviewed by Proactive Investors About the Company's Antiviral Drug Development Against SARS-CoV-2 to Treat COVID-19.

    Media Release
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