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Ivermectin long-acting injectable - Medincell

Drug Profile

Ivermectin long-acting injectable - Medincell

Latest Information Update: 09 Apr 2020

At a glance

  • Originator MedinCell S.A.
  • Developer MedinCell S.A.; Monash University
  • Class Antimalarials; Antiparasitics; Macrolides; Skin disorder therapies
  • Mechanism of Action Chloride channel agonists
  • 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

  • Preclinical COVID 2019 infections; Malaria

Most Recent Events

  • 06 Apr 2020 Preclinical trials in COVID-2019 infections in Australia (SC)
  • 06 Apr 2020 Pharmacodynamics data from preclinical studies in COVID-2019 infections released by MedinCell
  • 25 Mar 2020 MedinCell signs a grant agreement with Unitaid for injectable ivermectin for Malaria

Development Overview

Introduction

A long-acting single three month injectable ivermectin, is being developed by MedinCell for the treatment of malaria and COVID-2019 infections. The company develops long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. The BEPO® technology controls and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. A single injection of three-month active ivermectin will allow for mass adoption unlike shorter-acting treatments, mostly oral, which require numerous renewal campaigns. Preclinical development is underway in Australia and France.

MedinCell intends to investigate ivermectin for the potential treatment of COVID-19 infections [1] .

Company Agreements

In March 2020, MedinCell entered into a grant agreement of up to $US6.4 million over three years with Unitaid, for formulation and preclinical activities of a three-month acting injectable ivermectin in low and middle income countries (LMICs). MedinCell will grant a non-exclusive license to the Medicines Patent Pool to ensure distribution of the final product via public sector in LMICs. Under the terms of the agreement, the Unitaid-funded Medicines Patent Pool is in charge of licensing agreements for the exploitation of patents for medicines in low and middle income countries will receive a non-exclusive license for the long acting product and will work to find appropriate commercialization partners to ensure that the ivermectin product based on MedinCell technology will be accessible where it is needed. [2]

Key Development Milestones

COVID-2019 infections

Results from preclinical studies established by Monash University were released by MedinCell [1] .

Drug Properties & Chemical Synopsis

  • Route of administration SC
  • Formulation Injection
  • Class Antimalarials, Antiparasitics, Macrolides, Skin disorder therapies
  • Target Chloride channel
  • Mechanism of Action Chloride channel agonists
  • WHO ATC code

    J05A-X (Other antivirals)

    P01B (Antimalarials)

  • EPhMRA code

    J5B9 (Antivirals, others)

    P1D (Anti-Malarials)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical Australia SC / Injection MedinCell S.A., Monash University 06 Apr 2020
Malaria - - Preclinical France unspecified / Injection MedinCell S.A. 25 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
MedinCell S.A. Originator France
MedinCell S.A. Owner France
Medicines Patent Pool Market Licensee Switzerland
UNITAID Funder Switzerland
Monash University Collaborator Australia

Scientific Summary

Pharmacodynamics

Summary

Preclinical

In preclinical studies, ivermectin killed coronavirus in a laboratory setting in 48 hours. Additionally, a single treatment of ivermectin also demonstrated a ~5000-fold reduction in virus at 48h in cell culture [1]

Development History

Event Date Update Type Comment
06 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in Australia (SC) [1] Updated 09 Apr 2020
06 Apr 2020 Scientific Update Pharmacodynamics data from preclinical studies in COVID-2019 infections released by MedinCell [1] Updated 09 Apr 2020
25 Mar 2020 Licensing Status MedinCell signs a grant agreement with Unitaid for injectable ivermectin for Malaria [2] Updated 06 Apr 2020
25 Mar 2020 Phase Change - Preclinical Preclinical trials in Malaria in France (unspecified route) [2] Updated 06 Apr 2020

References

  1. MedinCell Has Launched a COVID-19 Research Initiative Based on Its Experience to Formulate Long-Acting Injectable Ivermectin.

    Media Release
  2. MedinCell Receives $ 6.4 Million Grant From Unitaid to Fight Malaria.

    Media Release
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