Algernon Pharmaceuticals Inc said it had filed a pre-Investigational New Drug (IND) meeting request with the US Food and Drug Administration (FDA) over its repurposed drug Ifenprodil for chronic cough, which could see a Phase 2 clinical trial start in the US as early as the second quarter of 2022.
It comes after the pharma group recently announced positive trending data from its Phase 2 study of the drug on idiopathic pulmonary fibrosis and chronic cough, which is currently taking place in Australia and New Zealand.
"This submission to the U.S. FDA underscores our commitment to patients with refractory chronic cough," said Christopher J. Moreau, the CEO of Algernon, in a statement.
"Many of these patients experience a significant negative impact on their quality of life, and there are currently no approved treatments."
READ: Algernon Pharmaceuticals files pre-IND meeting request with FDA for Ifenprodil small cell lung cancer study
Chronic cough is defined as one lasting more than eight weeks and affects around 10% of the adult population globally.
In some cases, symptoms cannot be resolved by treating underlying conditions, which is known as refractory chronic cough (RCC), for which there is currently no approved treatment.
Ifenprodil may represent a potential novel “first-in-class” treatment for chronic cough, said Algernon.
"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 US," it said.
"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," it added.
Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them into new human trials, developing new formulations and seeking new regulatory approvals in global markets.
Contact the author at giles@proactiveinvestors.com