VANCOUVER, British Columbia, Dec. 02, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPD) a clinical stage pharmaceutical development company is pleased to announce that it has added a clinical trial site in Australia for its ongoing Phase 2 NP-120 (Ifenprodil) idiopathic pulmonary fibrosis (“IPF’) and chronic cough study. Corresponding with the recent opening up of the country from its COVID-19 lockdown policies, the Company is now projecting full enrollment of the trial by the end of December 2021, with a data readout in calendar Q2, 2022.
The Company announced in September 2021, that it had received positive trending interim data from the chronic cough part of its 20-patient Phase 2 IPF and chronic cough study. The interim analysis examined 24-hour total and waking cough counts measured using an ambulatory cough monitor at baseline and after 4 and 12 weeks of treatment with 20 mg of Ifenprodil, three times daily.
The data showed a trend to a relative reduction in cough count when compared to each patient’s baseline measurement control. In October 2021, the Company submitted a request to the U.S. Food and Drug Administration for a pre-IND (Investigational New Drug) meeting on the investigation of Ifenprodil for a planned Phase 2 trial for treatment of refractory chronic cough.
Phase 2 IPF & Chronic Cough Study Summary
The purpose of this proof-of-concept Phase 2 human trial is to determine the efficacy of Ifenprodil in the preservation of lung function in IPF patients (including biomarkers of fibrosis) and its associated cough. There are 7 sites in total now participating in the study with 5 located in Australia and 2 in New Zealand with the new additional site just added, located in Perth.
Ifenprodil has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a mouse model of IPF. In addition, Ifenprodil significantly reduced both cough frequency and onset in a guinea pig acute cough model.
“We are very pleased to be able to provide this update to the market on our IPF and chronic cough study,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “The lockdowns as a result of COVID-19 have had a very serious negative effect on clinical trial enrollment globally, and with this relaxation of policies in Australia we look forward to moving the trial towards its successful completion.”
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils and certain types of cancer cells.
About Algernon Pharmaceuticals
Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.
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