Algernon Pharmaceuticals files end of Phase 2 meeting request with FDA for its coronavirus trial of Ifenprodil

Algernon Pharmaceuticals Inc (CSE:AGN) (FRA:AGW) (OTCQB:AGNPF) said it has filed an end of Phase 2 meeting request (EOP2) with the US Food and Drug Administration (FDA) based on the completion of the Phase 2b part of its Phase 2b/3 coronavirus (COVID-19) trial of NP-120 (Ifenprodil). 

In a statement, the company said the purpose of an EOP2 meeting is to facilitate interaction between the FDA and sponsors, who seek guidance related to clinical trial design, to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan (including protocols and endpoints for adequacy), and to identify the information necessary to support a marketing application. 

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Under FDA guidelines, Algernon said it can expect a response within 70 days but with the topic being a COVID-19 clinical trial, the response may be expedited.

In late March, the company announced key topline findings from Phase 2b: 

• All-Cause Mortality. At Day 15 of the study (the last day of treatment), there was 0% mortality in the 20 milligrams (mg) dose Ifenprodil treatment arm compared to a 3.3% mortality rate in the untreated control arm. For a Phase 3 trial to be sufficiently powered to confirm this endpoint, it is projected that 1,900 patients would need to be enrolled to reach a statistically significant result.
• Oxygenation (SpO2). Of patients with a low blood oxygen level (less than 94%), 100% of patients in the 20mg dose treatment arm returned to normal levels of oxygen at day 4 compared to day 9 for patients in the untreated arm. Power calculations project that 450 patients would be required to confirm a statistically significant result with this endpoint in a Phase 3 trial.
• Time in ICU. Topline results for this endpoint indicate that there was also a strong trend to less time spent in the ICU in the overall study by patients in the 20mg dose arm, as compared to patients in the untreated arm. However, the company cautioned that additional, confounding variables were detected, and these numbers need to be confirmed with additional analysis, as well as power calculations conducted to project the required size for a Phase 3 study.

The company reiterated that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 coronavirus) at this time.

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