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Find Clinical Drug Pipeline Developments & Deals by BioSig Technologies
ViralClear announced the halting of its signal finding trial, which is a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy & Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients with Advanced Coronavirus Disease 2019.
The agreement between ViralClear Pharmaceuticals, Inc. (Parent company BioSig Technologies, Inc. Nasdaq:BSGM) and Sorrento Therapeutics will allow for testing of merimepodib with neutralizing antibodies in the Golden Syrian hamster model of COVID-19.
Size of ongoing Phase 2 trial of merimepodib in combination with remdesivir increased from 40 to 80 subjects, with focus on hospitalized patients requiring non-invasive ventilation/high flow oxygen devices.
Merimepodib is intended to be orally administered and has demonstrated broad-spectrum in-vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures.
The companies together are undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators.
Under the terms of the agreement, Catalent will be developing two oral dosage forms of ViralClear’s broad-spectrum anti-viral agent, merimepodib: a solution and a solid oral dosage form.
Randomized, double-blind, placebo-controlled Phase II trial of merimepodib to be conducted in adults with COVID-19 who are hospitalized and require supplemental oxygen or are on non-invasive ventilation or high-flow oxygen devices.
ViralClear plans to use the proceeds of this offering for the development, including phase II human clinical trials, of its product candidate merimepodib, a broad-spectrum anti-viral agent.
The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.
Merimepodib in combination with remdesivir decreases viral production of SARS-CoV-2 to undetectable levels in pre-clinical testing. Even at low concentrations of both drugs significant reduction in viral production occurs.
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