Algernon Pharmaceuticals Provides Year End Summary of Key Activities

VANCOUVER, British Columbia, Dec. 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 provide a summary of the Company’s key activities this past calendar year.

NP-120 (Ifenprodil) Idiopathic Pulmonary Fibrosis (IPF) & Chronic Cough Clinical Research Program

• March 30 - Submitted for ethics approval in Australia for a Phase 2 study of the Company’s re-purposed drug Ifenprodil for IPF and chronic cough.
• May 6 - Received first ethics approval from the Royal Brisbane & Women’s Hospital, Human Research Ethics Committee.
• July 7 - Began screening patients for suitability at five sites in total that are participating in the study, with three located in Australia and two in New Zealand.
• August 5 - Announced that the first patient had been dosed at the Waikato Hospital located in Hamilton, New Zealand.
• October 13 - Announced that the IPF and chronic cough study reached 25% of its enrollment target.

Ifenprodil COVID-19 Clinical Research Program

• March 6 - Announced exploring the potential of using Ifenprodil as a novel treatment for COVID-19 based on an independent study that found that Ifenprodil significantly reduced acute lung injury and improved survivability in an animal study with H5N1 infected mice. H5N1 is the most lethal form of influenza known to date with an over 50% mortality rate.
• March 13 - Filed a pre-IND (Investigational New Drug) meeting request with the U.S. Federal Drug Administration (U.S. FDA), initiating formal communications to investigate Ifenprodil in a multinational Phase 2b/3 clinical trial for COVID-19.
• March 19 - Agreed to support an investigator-initiated Phase 2 clinical trial of Ifenprodil for COVID-19 patients in South Korea (subsequently withdrawn due to low patient enrollment).
• March 23 - Awarded the contract to manufacture the Company’s own supply of the active pharmaceutical ingredient for Ifenprodil, to U.S. based Cascade Chemistry. 
• April 22 - Submitted a Clinical Trial Application (CTA) to Health Canada for the Company’s planned multinational Phase 2b/3 COVID-19 study of Ifenprodil. 
• April 29 - Received a No Objection Letter from Health Canada for its CTA.
• May 25 - Submitted an Investigational New Drug (IND) application with the U.S. FDA for its planned multinational Phase 2b/3 COVID-19 study of Ifenprodil.
• June 4 - Received clearance from the U.S. FDA for its IND application.
• June 25 - Received ethics approval from a central institutional review board for U.S. study sites.
• July 16 - Completed a clinical trial agreement with Westchester Research Center at Westchester General Hospital in Miami, Florida, the first active U.S. clinical study site.
• August 5 - Announced enrollment of first patient for its Ifenprodil COVID-19 study.
• August 13 - Announced enrollment of its first patient from the U.S. for its Ifenprodil COVID-19 study.
• October 30 - Announced that at its second review meeting, the Ifenprodil COVID-19 study external Data and Safety Monitoring Board had once again unanimously approved the continuation of the Company’s Ifenprodil COVID-19 study (first approval announced on September 16^th). 
• November 30 - Announced that the final patient had been enrolled in its Ifenprodil COVID-19 study.
• December 15 - Reported, in a descriptive format, positive trending interim data for the Phase 2b part of the Company’s Ifenprodil COVID-19 study.
• December 24 - Announced that the last patient from the Phase 2b part of its Ifenprodil COVID-19 study had completed both the treatment period and two week follow up.

Finance