Algernon Pharmaceuticals plans meeting with the US FDA to prepare for upcoming Phase 3 Ifenprodil coronavirus trial

Algernon Pharmaceuticals plans meeting with the US FDA to prepare for upcoming Phase 3 Ifenprodil coronavirus trial

Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) (FRA:AGW) plans to file an End-of-Phase 2 meeting request for a potential Phase 3 trial using Ifenprodil to treat coronavirus (COVID-19).  The company told investors it will formalize its discussions with the US Food and Drug Administration (FDA) with the application, based on the completion of the Phase 2b trial.  Algernon said it had completed its initial review of the full data set and will look for the FDA’s guidance on how to move forward with the Phase 3 portion of the study.  READ: Algernon Pharmaceuticals appoints Dr Steven L. Wolf as a consultant for its clinical research program for the treatment of stroke An End-of-Phase 2 (EOP2) meeting is designed to facilitate dialogue between the FDA and Algernon so that the two can work together on evaluating practices for the next trial, including protocols and endpoints, Algernon said. The meeting will focus on data from three key endpoints in Phase 2: all-cause mortality, oxygenation and time spent in intensive care, from the 20 mg Ifenprodil treatment arm of the study. The Vancouver-based company is preparing a briefing package that includes a summary of the study data and a protocol synopsis for Phase 3. Algernon told shareholders that while the full data set review confirmed no significant changes were observed compared to the untreated arm of the study, the data showed a negative dose-effect trend with some clinical outcomes. According to the company, this could represent a “class effect” observed at doses higher than those at which a more customary dose-response relationship is shown, and may inform observations on the 40 mg dose data. Algernon noted that “very little” historical data existed to guide dosing for the study of Ifenprodil in COVID-19 patients, and the company chose to include a high dose 40mg treatment arm in the study, in view of Ifenprodil’s “considerable” safety record. “When we consider the totality of the study’s data set, we are very confident that the next appropriate step is a formal EOP2 meeting with the FDA in order to discuss the results and explore the potential of a Phase 3 trial,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “We look forward to feedback from the FDA so that we can determine our next steps.” Contact Angela at angela@proactiveinvestors.com Follow her on Twitter @AHarmantas

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