Algernon Pharmaceuticals Inc. a clinical stage pharmaceutical development company is pleased to announce that the last patient has completed the treatment period in its Phase 2 proof of concept study of NP-120 (“Ifenprodil”) for idiopathic pulmonary fibrosis (“IPF”) and chronic cough.
The Company is projecting that topline data will be available in July 2022.
“We are pleased to be coming closer to this value inflection point in our Phase 2 clinical trial for IPF and chronic cough, both debilitating conditions with limited treatment options,” said Christopher J. Moreau, CEO of Algernon. “We believe Ifenprodil has a unique mechanism of action when compared to the current standard of care for IPF and the drugs in development for chronic cough.”
Phase 2 Study Summary:
The purpose of this proof-of-concept Phase 2 human trial is to determine the safety and efficacy of Ifenprodil in patients with IPF and its associated cough.
In this open label, single-arm study, 20 patients were enrolled that had a diagnosis of IPF and a self-described moderate or worse cough (a score of >40mm on a cough visual analogue scale). Patients were treated with Ifenprodil (20 mg TID) for 12 weeks.
The primary endpoint of the IPF part of the study is the proportion of patients who achieve zero reduction in lung function at 12 weeks vs. baseline. Lung function was measured by forced vital capacity (“FVC”).
The primary endpoint for the chronic cough portion of the study is a 50% reduction in average 24-hour cough count at 12 weeks vs. baseline. Cough counts were recorded using an ambulatory cough monitor.
However, based on data seen in recent IPF and chronic cough trials from other companies, Algernon will also perform a pre-specified subgroup analysis on patients with higher baseline cough counts. In addition, the Company will also measure the proportion of patients with a less than 2.5% reduction in FVC.
In addition to safety and tolerability, the effect on serum biomarkers of fibrosis will also be reported including proC3, C3M, proC5, C5M, proC6, C6M and reC1M.
“Despite recent advances in the treatment of IPF, its prognosis remains dismal, with 50% mortality expected within 3-4 years,” said Dr. Martin Kolb, professor of respirology at McMaster University and Algernon medical consultant. “New treatment options are needed, and I look forward to seeing the results of Algernon’s proof of concept Phase 2 trial.”