First Wave plans to repurpose Sanofi’s capeserod as GI therapy

First Wave will repurpose Sanofi’s Alzheimer’s drug as a gastrointestinal therapy with plans to initiate clinical trials in 2024.

Capeserod is a selective partial agonist of the serotonin type 4 (5-HT4) receptor. Image Credit: Keitma / Shutterstock.

First Wave BioPharma has acquired Sanofi’s capeserod with plans to repurpose it as a gastrointestinal (GI) disease therapy.

Following the news, First Wave’s stock skyrocketed by over 80% in pre-market trading. The US-based company has a market cap of $3.112m.

The agreement includes a $500,000 upfront payment, with developmental and commercial milestone payments of up to $46m and $235m, respectively.

Additionally, Sanofi would have the right of first refusal on any capeserod sublicensing agreement and would be entitled to a percentage of any licensing payments. Sanofi also reserves the first refusal right to reacquire capeserod during development.

Capeserod is a selective partial agonist of the serotonin type 4 (5-HT4) receptor. In the GI tract, these receptors perform various functions, including gastric emptying, decreasing oesophageal reflux, and promoting intestinal peristalsis.

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First Wave plans to meet with the US Food and Drug Administration (FDA) to ascertain a developmental and regulatory pathway for capeserod and plans to initiate clinical trials in 2024.

First Wave CEO James Sapirstein said: “Capeserod has been investigated in multiple clinical trials involving over 600 patients and through this research and AI-based analyses evidence emerged suggesting the drug possesses a unique mechanism of action that is applicable to several GI indications underserved by currently available therapeutics.

“We intend to immediately initiate discussions with the FDA focused on a development and regulatory plan that would enable us to begin Phase II clinical trials of capeserod in 2024.”

In June, Sanofi partnered with BioMed X to research an artificial intelligence (AI)-driven drug discovery platform.