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January 17, 2022

Algernon receives positive FDA feedback on Phase IIb chronic cough trial

The pre-IND meeting guided the company on the Phase IIb protocol design and selection of trial endpoints.

The US Food and Drug Administration (FDA) has provided positive feedback for Algernon Pharmaceuticals’ Phase IIb clinical trial of NP-120 (ifenprodil) to treat chronic cough. 

A receptor antagonist of N-methyl-D-aspartate (NMDA), ifenprodil precisely acts on the NMDA-type subunit 2B (GluN2B).

The feedback was provided by the agency at the pre-Investigational New Drug (pre-IND) meeting for the therapy.

The meeting provided guidance on the Phase IIb protocol design submitted by Algernon and the endpoints that were selected, according to an announcement.

Furthermore, the FDA sought completion of standard genotoxicity testing before commencing the trial, which Algernon expects to require nearly 90 days to complete.

The company had requested for the pre-IND meeting to advance the Phase IIb trial of the therapy to treat chronic cough in the US. 

Algernon CEO Christopher Moreau said: “We are very pleased with the response we received from the FDA. 

“We look forward to the final data set from our IPF and chronic cough study so that we can plan our next steps.”

In September last year, the company reported a positive trend in the interim results from the chronic cough portion of a Phase II trial, which is set in Australia and New Zealand and for idiopathic pulmonary fibrosis (IPF) and chronic cough.

The interim assessment analysed 24-hour and waking cough counts recorded with an ambulatory cough monitor at baseline and following treatment with thrice-daily 20mg dose of ifenprodil for four and 12 weeks. 

Results demonstrated a trend to a relative decline in cough count as against the baseline.

Ifenprodil was found to offer a significant decline in cough count and a delay in cough development versus vehicle controls in an acute cough in vivo animal study. 

In September 2020, the Data and Safety Monitoring Board (DSMB) recommended the company to continue its Phase IIb/III trial of Ifenprodil for Covid-19.

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