Algernon Pharmaceuticals Inc. said that it plans to file a pre-Investigational New Drug (IND) meeting request with the US Food and Drug Administration (FDA) for its repurposed drug NP-120 (Ifenprodil) in a Phase 2 chronic cough study.
The Vancouver-based clinical-stage pharmaceutical development company said the decision to expand its Ifenprodil research program was based on positive trending interim data received by the company from the chronic cough part of its 20-patient Phase 2 idiopathic pulmonary fibrosis (IPF) and chronic cough study being conducted in Australia and New Zealand.
Algernon said 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,” said the company.
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"The company’s pilot IPF and chronic cough Phase 2 trial was neither powered nor intended to show statistical significance but was designed to identify signals and the magnitude of any clinical effects,” pointed out the company.
While chronic cough is a symptom that occurs in a subset of patients with IPF, it is often severe and difficult to treat in IPF patients compared to chronic cough arising from other causes. Typically, IPF patients are excluded from clinical trials for chronic cough patients. Not surprisingly, a relative reduction of cough count in these patients is being viewed by Algernon as encouraging news.
The new planned Phase 2 study will be solely focused on chronic cough patients, designed to ensure statistical significance, and will also have a placebo control. The Phase 2 clinical trial will also take into consideration the study designs of other chronic cough clinical trials, including focusing on patients who have a more frequent cough.
Algernon said it plans to seek guidance from the FDA for a Phase 2 study as its next step, having evaluated Ifenprodil’s safety profile in its 150-patient multinational study for coronavirus (COVID-19).
“We believe that Ifenprodil represents a potential novel first-in-class treatment for chronic cough,” Algernon Pharmaceuticals CEO Christopher J Moreau said in a statement. “We will update the market when we have filed the pre-IND meeting request and look forward to receiving feedback from the FDA in due course.”
A chronic (persistent) cough is a cough lasting eight weeks or longer in adults, or four weeks in children. Chronic cough can interrupt sleep, cause exhaustion, and in severe cases can cause serious vomiting, lightheadedness and rib fractures.
The cough remedies market was $1.40 billion in 2018, and is growing at a compound annual growth (CAGR) rate of 6.64% from 2019-to-2024, according to market research consulting firm IndustryARC.
NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.
lgernon is a drug repurposing company that investigates safe, already approved drugs for new disease applications. It has taken generic neurological drug Ifenprodil that Sanofi developed in the 1970s, which is approved for use in South Korea and Japan and is attempting to repurpose it as a potential chronic cough and IPF treatment.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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