Final Approval Sought for Phase 2 Trial of Repurposed NP-120 for IPF
Algernon Pharmaceuticals announced that it submitted a request for the final approval needed to open a Phase 2 clinical trial in Australia evaluating NP-120 (ifenprodil), a repurposed compound, as a treatment of idiopathic pulmonary fibrosis (IPF) and its associated chronic cough.
NP-120 belongs to a class of medications known as N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonists. It also binds to a protein called Sigma-1 receptor. Recent studies suggest a link between these two types of receptors and fibrosis. The mechanism through which NP-120 exerts an anti-fibrotic effect, however, is not fully understood.
A response to this final submission, called an ethics approval, is expected by the end of May.
Algernon focuses on repurposing medications approved for use in countries other than the U.S. or European Union. Repurposed medications treat conditions other than those for which they were originally developed.
In preclinical studies, NP-120 was shown to have an anti-inflammatory effect and to ease tissue scarring (fibrosis) in the lungs of a mouse model of IPF. Algernon reports that the repurposed therapy did better than two approved IPF therapies — Genentech’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib) — in reducing fibrosis in these mice.
In a guinea pig model of acute cough, NP-120 was also seen to significantly delay the onset of a first cough episode, and to reduce the frequency of coughing.
The proposed, proof-of-concept Phase 2 trial (NCT04318704) aims to determine safety and tolerability NP-120, and its efficacy in preserving lung function in IPF patients and in reducing the frequency of cough associated with the disease. The study plans to enroll up to 20 patients, with all treated with NP-120 at 20 mg three times a day.
The trial is expected to begin enrolling patients in June.
“This is major milestone for the Company as it takes its first step in formalizing its model of re-purposing known safe drugs, investigating them in animal models for new diseases, and moving them quickly and efficiently into Phase 2 clinical trials,” Christopher J. Moreau, Algernon’s CEO, said in a press release.
Algernon did not address the ongoing and global COVID-19 pandemic in its release, but the strain on healthcare systems and risk of infection to patients and health professionals have affected a number of ongoing and planned studies. People with respiratory diseases, including pulmonary fibrosis, are also thought to be a risk of more severe infection.