Algernon Gets Nod to Launch Phase 2 IPF Trial of NP-120 in Australia

Algernon Pharmaceuticals received the first ethics approval for its Phase 2 clinical trial in Australia evaluating its repurposed compound NP-120 (ifenprodil) for the treatment of idiopathic pulmonary fibrosis (IPF) and associated chronic cough.

Royal Brisbane and Women’s Hospital‘s Human Research Ethics Committee has approved two sites — the Cairns Hospital in Queensland and the Concord Repatriation General Hospital in New South Wales — to participate in the trial.

The company is waiting for three additional approvals for one more clinical site in Australia and two sites in New Zealand. Enrollment is expected to begin in late June, according to Algernon.

“Novotech, our Asia-Pacific [contract research organization] partner continues to meet their projected timelines for this very important study,” Christopher J. Moreau, CEO of Algernon, said in a press release. “We look forward to conclusion of the ethics approval process and announcing the enrolment of the first patient in the trial.”

Algernon’s lead compound NP-120 is an antagonist of the NMDA receptor glutamate that also binds to a protein called the sigma-1 receptor. The compound was originally developed by Sanofi and approved as an oral medication for blood circulation disorders, but recent studies suggest it could also be used for pulmonary fibrosis.

In fact, both the NMDA receptor glutamate and sigma-1 receptor have been implicated in fibrosis, or tissue scarring, in the lungs.

Thus, Algernon is testing NP-120 as a potential treatment for pulmonary fibrosis. The advantage of using approved medications is that they have already been proven safe for human use, which could largely reduce the amount of testing needed for other indications.

The upcoming Phase 2 trial (NCT04318704) will investigate the safety, tolerability, and efficacy of NP-120 in people diagnosed with IPF. An estimated total of 20 participants will be given 20 mg NP-120 three times a day.

The trial’s main goals are to determine the number of patients who attain a 50% or higher reduction in their daily cough — measured using an ambulatory cough monitor — and those who have their lung function preserved throughout the study, assessed through the forced vital capacity measure. Biomarkers of fibrosis will also be assessed.

Preclinical studies on NP-120 have already demonstrated promising anti-inflammatory and anti-fibrotic effects in a mouse model of IPF, with NP-120 found to be better than approved IPF medications — namely Esbriet (pirfenidone) and Ofev (nintedanib) — for reducing lung fibrosis.