Algernon Pharmaceuticals Inc said it has added a clinical trial site in Australia for its ongoing Phase 2 NP-120 (Ifenprodil) idiopathic pulmonary fibrosis (IPF) and chronic cough study.
Corresponding with the recent opening up of the country from its COVID-19 lockdown policies, the company said it is now projecting full enrollment of the trial by the end of December 2021, with a data readout in its second quarter of 2022.
Algernon announced in September 2021 that it had received positive trending interim data from the chronic cough part of its 20-patient Phase 2 IPF and chronic cough study. The interim analysis examined 24-hour total and waking cough counts measured using an ambulatory cough monitor at baseline and after four and 12 weeks of treatment with 20 milligrams (mg) of Ifenprodil, three times daily.
READ: Algernon Pharmaceuticals appoints former Medicure financial chief James Kinley as CFO
The data showed a trend to a relative reduction in cough count when compared to each patient’s baseline measurement control.
In October 2021, the company submitted a request to the US Food and Drug Administration for a pre-IND (Investigational New Drug) meeting on the investigation of Ifenprodil for a planned Phase 2 trial for the treatment of refractory chronic cough.
Algernon said the purpose of this proof-of-concept Phase 2 human trial is to determine the efficacy of Ifenprodil in the preservation of lung function in IPF patients (including biomarkers of fibrosis) and its associated cough.
There are seven sites in total now participating in the study with five in Australia and two in New Zealand with the new additional site just added, located in Perth.
“We are very pleased to be able to provide this update to the market on our IPF and chronic cough study,” said Algernon CEO Christopher Moreau in a statement. “The lockdowns as a result of COVID-19 have had a very serious negative effect on clinical trial enrollment globally, and with this relaxation of policies in Australia we look forward to moving the trial towards its successful completion.”
Ifenprodil has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a mouse model of IPF. In addition, Ifenprodil significantly reduced both cough frequency and onset in a guinea pig acute cough model.
Contact the author: patrick@proactiveinvestors.com
Follow him on Twitter @PatrickMGraham