October 2, 2020 Innovation Pharmaceuticals Announces Pre-IND Meeting Request Granted by FDA for the Study of Brilacidin for the Treatment of COVID-19 Brilacidin WAKEFIELD, MA – October 2, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that earlier this week the Company submitted a pre-IND meeting request to the FDA in advance of a planned study of Brilacidin, a defensin-mimetic drug candidate, for the treatment of COVID-19. The request for the pre-IND meeting follows the FDA guidance issued in May 2020, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.” Confirmation of the meeting being granted by FDA, with return of written responses, has been received.
In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis.
Extensive pre-clinical research, nearing completion, conducted at independent laboratories reinforces the antiviral potential of Brilacidin against SARS-CoV-2, the novel coronavirus responsible for COVID-19. Numerous hospitals and provider networks domestically and abroad have expressed a strong interest in participating in the Brilacidin for COVID-19 clinical trial. Given such interest in Brilacidin, the Company anticipates the planned COVID-19 trial can be rapidly recruited and completed.
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