Algernon provides additional facts on its interim data for its Phase 2b/3 Ifenprodil COVID-19 study

Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) provided additional information on Thursday on its interim data report for the Phase 2b stage of its Phase 2b/3 clinical study of Ifenprodil for coronavirus (COVID-19). On Tuesday, the Vancouver-based company had said that data is pointing to a trend towards a reduction of patients needing mechanical ventilation in the high-dose Ifenprodil treatment arm by day 15 of the trial, as compared to patients in the untreated arm.     Algernon also said that it saw a trend in the high dose group to reduce the National Early Warning Score (NEWS) that determines the degree of illness more quickly than the control group after treatment was initiated, suggesting that the treated patients are recovering more quickly. READ: Algernon Pharmaceuticals reveals positive trending data from Phase 2b portion of Ifenprodil to treat COVID-19 In a statement on Wednesday, Algernon said its Phase 2b/3 COVID-19 clinical trial protocol design was based on WHO guidelines. This design allows for a secondary endpoint to be used as the primary endpoint going forward in the Phase 3 part of the trial. Due to the complexity of clinical trials, one endpoint can show efficacy while other endpoints do not, said the company. For example, in Algernon’s interim data, by day 15, there was a trend towards fewer patients requiring mechanical ventilation in the high dose Ifenprodil treatment arm, as compared to patients who were in the untreated arm of the study, even though all patients had similar mean WHO and NEWS scores. Algernon said it has a number of US Food and Drug Administration (FDA) accepted COVID-19 efficacy endpoints in its trial Phase 2b/3 trial design including respiratory failure including need for mechanical ventilation, need for intensive care, need for hospitalization, objective measure of sustained improvement linked to oxygenation and measures of clinical improvement linked to WHO, NEWS scores, and mortality. Algernon has always planned to consult with the FDA on a possible path to EUA after the Phase 2b final data set is completed. “The company believes that the interim data represents a very positive step in the investigation of Ifenprodil as a potential therapeutic treatment for COVID-19,” said Algernon Pharmaceuticals CEO Christopher J Moreau. “We were very pleased to see positive trending data with a ventilation related endpoint that is favored by the FDA for COVID-19 trials. Further, Algernon has only provided interim data on three endpoints from day 15 of its 30-day Phase 2b/3 Ifenprodil COVID-19 study, with the majority of the data still to be reported,” he added. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive