Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) said it has received positive feedback from the US Food and Drug Administration at its pre-Investigational New Drug (pre-IND) meeting for its investigation of NP-120, or Ifenprodil, for the treatment of chronic cough.
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B).
The Vancouver-based company said that the FDA meeting produced helpful guidance on the Phase 2b protocol design that was submitted by the company as well as the endpoints that had been selected. The US federal agency also requested standard genotoxicity testing be completed prior to beginning the Phase 2b study, which the company estimates will take approximately 90 days to complete.
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“We are very pleased with the response we received from the US FDA,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals in a statement. “We look forward to the final data set from our IPF and chronic cough study so that we can plan our next steps.”
The company filed the pre-IND meeting request to seek guidance in the event the company decides to move forward with a chronic cough Phase 2b study in the US. On September 20, 2021, the company reported positive trending interim data from the chronic cough part of its 20-patient proof-of-concept Phase 2 idiopathic pulmonary fibrosis (IPF) and chronic cough study being conducted in Australia and New Zealand.
The interim analysis examined 24-hour and waking cough counts measured using an ambulatory cough monitor at baseline and after 4 and 12 weeks of treatment with Ifenprodil, 20 mg three times daily. The data showed a trend to a relative reduction in cough count when compared to each patient’s baseline measurement control, the company said.
The company noted that in its pre-clinical animal cough study, Ifenprodil showed both a dramatic reduction in cough count and a delay in cough onset when compared to vehicle controls in a well-accepted acute cough in-vivo animal study. Gefapixant, Merck’s lead phase 3 trial drug for chronic cough, was also tested in the study.
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.
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