Algernon Receives Clearance from Health Canada for Ifenprodil COVID-19 Phase 2b/3 Multinational Clinical Trial

VANCOUVER, British Columbia, April 30, 2020 (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 received a No Objection Letter from Health Canada to proceed with a NP-120 (Ifenprodil) COVID-19 Phase 2b/3 multinational clinical trial. The same study protocol is being prepared for submission to the U.S. FDA and Australian regulatory authorities.

“The study is an adaptive pilot to pivotal trial design based on guidance documents from the World Health Organization (WHO) to determine if Ifenprodil can improve clinical symptoms of COVID-19 by reducing the number of COVID-19 diagnosed patients from progressing to mechanical ventilation with intubation and death,” said Dr. Mark William’s, Algernon’s CSO.

The trial will begin as a Phase 2b study and after an interim analysis is performed on the first 100 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial. With positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3.

“We are very excited to have received clearance for our Phase 2b/3 study,” said Christopher J. Moreau CEO of Algernon. “We will begin to work immediately to get all aspects of the trial organized so that we can start as soon as possible including filing an IND for this same study with the U.S. FDA.”

The Company cautions that while it is preparing to begin a Phase 2 clinical trial shortly in South Korea and Canada, it is not making any express or implied claims that NP-120 (Ifenprodil) is an effective treatment for acute lung injury (ALI), the COVID-19 virus, or any other medical condition at this time.

Phase 2b/3 Study Protocol Overview

The trial will begin as a Phase 2b study enrolling 100 patients with moderate/severe disease, which corresponds with a score of 4 or 5 on the WHO ordinal clinical scale. Patients will be randomized in a 1:1 fashion to receive either standard of care (SOC) or SOC and Ifenprodil 20 mg (three times per day) for a two-week treatment period. An improvement in the ordinal clinical scale is the initial primary endpoint and a number of secondary endpoints including mortality, blood oxygen levels, time in the ICU and time to mechanical ventilation will be studied.