Algernon Secures Canadian Patent of NP-120 for IPF
Initially developed by Sanofi and approved for the treatment of circulatory disorders in Japan and South Korea, ifenprodil showed anti-scarring and anti-coughing effects in animal models and now is being tested in IPF patients in a proof-of-concept Phase 2 trial (NCT04318704).
A Notice of Allowance was received by the company. These notices are issued by the Canadian Patent Office to indicate an application merits the requested patent being issued.
The patent application (No. 3101853), titled “Compositions and Methods for Treating Idiopathic Pulmonary Fibrosis,” covers the composition, dosing, and potential use of NP-120, as well as two other compounds, for IPF.
Similar patent applications also are being reviewed in the U.S., Europe, China, and Japan.
“This is the first allowance notice received by the Company for one of its [therapies] being investigated under its innovative [treatment] repurposing program and it is another important step forward,” Christopher J. Moreau, Algernon’s CEO, said in a press release.
By repurposing compounds approved for one health condition to treat another disease, Algernon cuts both the costs and time required to develop a safe and effective treatment. The company focuses specifically on compounds that have never been approved in the U.S. or Europe to avoid off-label prescription writing.
Algernon’s intellectual property strategy for its repurposed compounds includes filing patent applications for novel salt forms, method of use, dosing, and formulation.
NP-120 is an orally available molecule that works by blocking N-methyl-D-aspartate-type subunit 2B (GluN2B), a specific type of receptor protein found in lung cells and many types of immune cells. Given that GluN2B is involved in glutamate signaling, which has been implicated in both coughing and fibrosis (tissue scarring), the therapy is expected to lessen these common features of IPF.
In a mouse model of IPF, NP-120 was shown to be superior to two IPF therapies — Genentech’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib) — in reducing lung fibrosis. In another study, the therapy outperformed MK-7264, Merck’s lead candidate for the treatment of chronic cough, at lowering cough frequency in a guinea pig model.
Based on these promising findings and NP-120’s already established safety profile, Algernon launched an open-label Phase 2 trial to evaluate the therapy’s safety and effectiveness in 20 IPF patients, up to 85 years old, with persistent, hard-to-treat cough.
Participants, currently being recruited at sites across Australia and New Zealand, are receiving a 20 mg tablet of NP-120 three times a day for up to 12 weeks (about three months).
The trial’s main goals are to investigate whether the therapy results in a 50% drop in cough daily frequency, as assessed with a portable cough monitor, and whether it preserves patients’ lung function.
Interim results showed a trend of cough frequency reduction after four or 12 weeks of treatment. These data prompted Algernon to request a meeting with the U.S. Food and Drug Administration in preparation for filing an application seeking permission to start clinical testing in the country.