Algernon Pharmaceuticals Inc (AGNPF)

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AGN: "is pleased to announce that it is planning a 180 patient, 90-day Phase 2b clinical study of NP-120 (“Ifenprodil”) for chronic cough to begin in Q3 of 2023."

"The planned study design will include the following elements:

Multinational, three-arm, randomized, double-blind, placebo-controlled trial to evaluate NP-120 in approximately 180 patients.

Patients will be randomized 1:1:1 to receive NP-120 (20mg TID) or NP-120 (40mg TID), or placebo for 12 weeks.

The primary endpoint will be the reduction in geometric mean 24-hr cough count over 12 weeks compared to placebo.

Secondary endpoints will include safety, tolerability and patient-reported quality-of-life measures.

"The design of Phase 2 studies in chronic cough have been validated in trials conducted by Merck & Co and Bellus Health,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “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.”

...GLTA...