New Trial for NP-120 in Chronic Cough Planned, IPF Study Delayed
Likely effort into reasons for efficacy after promise seen in IPF-chronic cough
A Phase 2b clinical trial testing NP-120 (ifenprodil) as a treatment for chronic cough is expected to begin later this year, according to the therapy’s developer, Algernon Pharmaceuticals.
But plans for a Phase 2b study of NP-120 in people with idiopathic pulmonary fibrosis (IPF) are postponed “until a later date,” the company announced in a press release.
“I am very pleased Algernon has decided to conduct a stand-alone, Phase 2b study for cough,” said Jacky Smith, PhD, a professor of respiratory medicine at the University of Manchester and Algernon’s lead chronic cough adviser.
NP-120 is designed to lessen coughing and ease lung inflammation
“I recommended, based on Algernon’s encouraging Phase 2a clinical data, that the company further explore ifenprodil in chronic cough in a well-designed, sufficiently powered study that will give clear answers on the potential efficacy of the drug in this population,” Smith said.
NP-120 is an oral therapy designed to block the activity of a protein receptor for the signaling molecule glutamate. Nerve cells help to regulate coughing by releasing glutamate to communicate with other cells in the body, and glutamate signaling is known to contribute to inflammation and fibrosis (scarring).
By blocking these processes, NP-120 aims to lessen coughing and ease lung inflammation. The experimental therapy was designated an orphan drug as a potential IPF treatment by the U.S. Food and Drug Administration (FDA) late last year.
Algernon sponsored a Phase 2a clinical trial (NCT04318704) in which 20 people with IPF and persistent cough were treated with NP-120 (20 mg three times a day) for about three months.
Results of this trial, which concluded in May, showed that more patients had stable or improved lung function than would be expected without treatment, and most reported better overall health. NP-120’s use also eased coughing, a finding Algernon considered particularly notable since cough in IPF patients can be “extremely difficult to treat.”
Pending discussions with the FDA, the upcoming Phase 2b trial is expected to enroll around 180 people with chronic cough who will be randomly assigned to NP-120 at a dose of 20 or 40 mg three times daily, or to a matched placebo, for about three months. Its main goal will be to assess the effect of treatment on cough frequency. Treatment safety, tolerability, and its effect on patients’ quality of life will also be evaluated.
“The design of Phase 2 studies in chronic cough have been validated in trials conducted by Merck & Co and Bellus Health. By mirroring the design of those studies, Algernon will have a direct benchmark for comparison and, if successful, a clear regulatory path for ifenprodil for the treatment of chronic cough,” said Christopher Moreau, CEO of Algernon.
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