Treatment has commenced in a Phase 2 clinical trial investigating the safety and effectiveness of NP-120 (ifenprodil), Algernon Pharmaceuticals‘ experimental treatment for chronic cough associated with idiopathic pulmonary fibrosis (IPF).
IPF patients often experience a persistent, hard-to-treat cough, which affects their overall health and quality of life. There currently is no approved therapy for this cough, and those used off-label typically do not provide the desired relief.
Initially developed by Sanofi for the treatment of circulatory disorders, ifenprodil is an oral compound that prevents glutamate signaling by selectively targeting a receptor called the NMDA-type subunit 2B (Glu2NB).
Past studies showed that ifenprodil lessened anti-inflammatory responses and reduced pulmonary fibrosis in a mouse model of IPF. In another study, ifenprodil lowered the occurrence and frequency of coughs in a guinea pig model.
Because ifenprodil is already approved (sold under the brand name Cerocal) and has an established safety history, the company was able to move directly into Phase 2 testing. The approved formulation of the therapy is widely used in Japan.
“Ifenprodil showed very promising results in our IPF and cough pre-clinical studies and so I am very pleased to announce our first patient in and the formal start of our clinical program,” Christopher J. Moreau, CEO of Algernon, said in a press release. “As the study progresses, the Company will make an assessment of the enrollment rate and will provide an update to the market on a projected completion date as well as when the data will be expected.”
The open-label trial (NCT04318704) is recruiting approximately 20 participants up to 85 years old with confirmed IPF diagnosed within the past seven years. Enrollment is currently open; information on contacts and sites is available here.
The goal of the trial is to determine ifenprodil’s effectiveness in preserving lung function in IPF patients and in treating its associated cough.
The primary outcome sought in the trial is a 50% or greater reduction in patients’ average number of coughs over 24 hours, compared with baseline, or the start of the trial. Cough frequency will be measured with an ambulatory cough monitor between baseline and week 12.
As a secondary objective, researchers will evaluate whether patients experience a worsening of forced vital capacity (FVC), a standard measure of lung function, during the same time period.
The trial is taking place at five sites, three of which are located in Australia and two in New Zealand. The first patient dosed was enrolled at Waikato Hospital in Hampton, New Zealand.
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