Early Trial Data Indicates NP-120 Could Ease Coughing in IPF
Patients with idiopathic pulmonary fibrosis (IPF) with chronic cough who are being treated with the investigational oral medication NP-120 (ifenprodil) in a small clinical trial tended to experience a reduction in coughing, according to the therapy’s developer Algernon Pharmaceuticals.
The company is funding an open-label Phase 2 trial (NCT04318704) that aims to test NP-120 in 20 IPF patients with persistent, hard-to-treat cough, a common symptom of the disease.
The trial, which began dosing patients last year, is still recruiting participants — children, adults, and older adults, up to age 85 — at six locations across Australia and New Zealand.
Results of an interim analysis of trial data were announced by the company last fall. Participants wore a monitor that measured coughing throughout the day, and coughing rates seen after four or 12 weeks of treatment with NP-120 — when given at a dose of 20 mg, three times daily — were compared with those seen at the start of the study.
Although the results showed there was a trend for cough counts to drop over the course of the trial, Algernon noted that this small proof-of-concept study was not designed to detect statistically significant differences in treatment effects.
But with these results in hand, the company requested a meeting with the U.S. Food and Drug Administration (FDA) in preparation for submitting an application requesting permission to start clinical testing in the U.S. At the meeting, the FDA gave Algernon helpful guidance on plans for a Phase 2b trial that the company is hoping to launch to test NP-120 in patients with chronic cough.
“We are very pleased with the response we received from the U.S. FDA,” Christopher J. Moreau, CEO of Algernon, said in a press release, adding, “We look forward to the final data set from our IPF and chronic cough study so that we can plan our next steps.”
The U.S. agency also requested that standard genotoxicity testing be completed before the start of the planned Phase 2b study. The goal of genotoxicity testing is to assess a compound’s ability to damage cells’ genetic information and cause potentially harmful mutations.
According to Algernon, this should take approximately 90 days, or around three months, to complete.
NP-120 works by blocking a specific type of protein receptor called N-methyl-D-aspartate-type subunit 2B (GluN2B), which is found in lung cells and many types of immune cells. By blocking this protein receptor, the experimental therapy is expected to interfere with glutamate signaling, which has been implicated in both coughing and fibrosis (tissue scarring).
Prior research done in multiple animal models has indicated that NP-120 can decrease fibrosis and lessen coughing.
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