Biotron has obtained positive guidance from the US Food and Drug Administration (FDA) on the design of the Phase II clinical trial of its lead antiviral drug, BIT225, to potentially treat Covid-19 in adults.
The latest guidance from the regulatory agency comes as a written response to the company’s pre-IND briefing package and request in March this year.
This package comprised an overview of preclinical and (HIV) clinical development and particular queries linked to regulatory needs for advancing to submitting an investigational new drug (IND) application for the therapy.
The guidance was sought for the design of the Phase II trial in newly diagnosed Covid-19 patients and assuring that the preclinical data package and production processes were sufficient to back this trial.
Biotron managing director Dr Michelle Miller said: “The FDA responses were constructive, highly informative, and provide direction in the design of the proposed Phase II clinical trial.
“The recommendations for a small, placebo-controlled, proof-of-concept, dose-finding study, with agreed endpoints, in line with studies for other respiratory diseases, including influenza, are very welcome.
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“The feedback on the existing supporting non-clinical studies and the manufacturing processes, specification and composition of the drug product was positive.”
The regulatory authority’s response indicates its interest in this new drug target that merges direct antiviral effect and immunomodulatory activities, the company added.
According to data from animal studies carried out at the Scripps Institute in San Diego, US, the drug showed protection from disease progression and the cytokine storm that was associated with severe respiratory disease development.
BIT225 quickly lowered viral loads in the lungs of infected animals which received the treatment before or after the Covid-19 infection.
With the latest guidance and acceptable trial design, Biotron plans to calculate its capital needs for the Covid-19 clinical programme and obtain funding from non-equity funding sources and possible partners.