Algernon Pharmaceuticals Files U.S. FDA Pre-IND Meeting Request for Ifenprodil Chronic Cough ...
VANCOUVER, British Columbia, Oct. 08, 2021 (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 filed a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (U.S. FDA) for its investigation of NP-120 (Ifenprodil) for a planned Phase 2 study for the treatment of refractory chronic cough. Ifenprodil, is an NMDA GluN2B subunit inhibitor and may represent a potential novel “first-in-class” treatment for chronic cough.
The Company recently announced positive trending data from its Phase 2 study of idiopathic pulmonary fibrosis and chronic cough that is currently ongoing in Australia and New Zealand. The results from an interim analysis of the chronic cough part of the study showed a relative reduction versus baseline in the mean 24-hour cough count in subjects after 12-weeks of treatment. There was also a decrease in the mean waking cough count at week 12 versus baseline (descriptive statistics).
Depending on the feedback from the U.S. FDA, the Company could begin its Phase 2 chronic cough study as early as Q2 of 2022 in the U.S. The Company wishes to thank Dr. Jacky Smith, Professor of Respiratory Medicine at the University of Manchester, and a leading global scientific expert on chronic cough, for her assistance with the protocol synopsis for the planned Phase 2 study. Dr. Smith joined the Algernon Medical and Scientific Advisory Board on February 7th, 2021.
“This submission to the U.S. FDA underscores our commitment to patients with refractory chronic cough,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc. “Many of these patients experience a significant negative impact on their quality of life, and there are currently no approved treatments.”
About Chronic Cough
Chronic cough (defined as a cough lasting more than 8 weeks) affects approximately 10% of the adult population globally and is one of the most common conditions for which medical care is sought. In a subset of cases, symptoms cannot be resolved by treatment of underlying conditions; this is known as refractory chronic cough (“RCC”). There is currently no approved treatment for RCC.
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 Inc.
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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