Algernon Pharma: Topline Data From Phase 2b/3 COVID-19 Trial of Ifenprodil

 Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce topline data from the Phase 2b part of its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil).

The purpose of the Phase 2b part of the study was to identify one or more approvable U.S. FDA endpoints that showed a strong enough signal to consider moving forward into a Phase 3 study.

Key topline findings include:

All Cause Mortality:

At Day 15 of the study (the last day of treatment) there was 0% mortality in the 20 mg dose Ifenprodil treatment arm compared to a 3.3% mortality rate in the untreated control arm, p=0.18. 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 (SpO2 <94%), 100% of patients in the 20 mg dose treatment arm returned to normal levels of oxygen at day 4 compared to day 9 for patients in the untreated arm (adjusted hazard ratio 1.91, 95% CI 0.97-3.77, p=0.061). 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 20 mg dose arm, as compared to patients in the untreated arm (adjusted hazard ratio 10.45, CI 1.23-88.61, p=0.0315). However, the Company cautions 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.

https://finance.yahoo.com/news/algernon-pharmaceuticals-announces-topline-data-120000226.html