VANCOUVER, British Columbia, March 16 (Bernama-GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that it has filed its pre-IND (Investigational New Drug) meeting request with the U.S. FDA. This initiates formal communications with the U.S. FDA regarding development of the Company’s repurposed drug NP-120 (Ifenprodil) for the treatment and prevention of acute lung injury (ALI) and acute respiratory distress syndrome associated with COVID-19 (coronavirus) infection. The request for a pre-IND meeting was accompanied by the complete pre-IND briefing document.
In the application, the Company has requested direction regarding the use of Algernon’s planned new propriety injectable and slow release formulation as well as the use of the Company’s currently available Ifenprodil drug supply, for a US clinical trial on an emergency use basis. This filing also includes clarification of the expanded access pathway, also known as the “compassionate use” pathway.