Participants in Phase 2 Trial of NP-120 Ask for Therapy for Personal Use
Participants in a Phase 2 trial testing Algernon Pharmaceuticals’ NP-120 (ifenprodil) in people with chronic cough associated with idiopathic pulmonary fibrosis (IPF) have asked to have the experimental medication for their personal use, Algernon announced.
The company noted in a press release that it’s “not making any express or implied claims that ifenprodil has the ability to cure or treat IPF or chronic cough at this time.” Top-line results from the Phase 2 trial are expected to be announced next month, according to Algernon.
Ifenprodil, the active agent in NP-120, targets a receptor protein called NMDA-type subunit 2B (GluN2B) to modulate the activity of a signaling compound called glutamate. The oral medicine was originally developed by Sanofi to treat circulatory system disorders and has been marketed under the brand name Cerocal.
Preclinical studies have shown that ifenprodil was able to reduce lung scarring in a mouse model of IPF and ease coughing in a guinea pig model.
Algernon sponsored a Phase 2 clinical trial (NCT04318704) to assess NP-120’s effectiveness, safety, and tolerability in IPF patients who have chronic cough. The trial began enrolling patients in 2020. It was open to IPF patients up to age 85 who were on stable standard-of-care treatment and who had reported a substantial cough.
The study enrolled 20 participants at sites in Australia and New Zealand. All were treated with NP-120, at a dose of 20 mg given three times per day for up to 12 weeks (about three months). Cough frequency was measured using a monitor that participants were asked to wear throughout the day.
The trial’s main goal was to see if NP-120 could reduce the number of daily coughs by at least 50% after 12 weeks. It also evaluated the proportion of patients showing no decrease (decline) in forced vital capacity, a measure of lung function based on how much air a person can forcefully exhale after a deep breath.
Participants who finished the study have requested additional supplies of NP-120 for their own personal use. Algernon said it’s working with clinical sites to help patients access the medication through the Australian Government’s Special Access Scheme, which allows access to unapproved therapies.
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