Sanofi slings long-dormant Alzheimer's asset to First Wave for repurposing, secures buy back rights

Sanofi has handed First Wave BioPharma a chance to reposition a long-dormant molecule. The biotech is paying $500,000 upfront for capeserod as part of a deal that gives Sanofi the right of first refusal to buy the asset back.

Investigators stopped phase 2 clinical trials of capeserod in Alzheimer’s disease and urinary incontinence almost 20 years ago. Now, First Wave is exhuming the molecule, which is backed by safety data in more than 600 patients, with a view to repositioning it in gastrointestinal disorders. The biotech plans to move the candidate into clinical trials next year. 

First Wave said the decision to repurpose capeserod is underpinned by “AI-empowered analyses” that suggest its mechanism of action has potential applications for several gastrointestinal disorders. The possible uses cover “multibillion-dollar markets” with significant unmet clinical needs, according to First Wave.

Capeserod is a selective partial agonist of 5-HT4, a target that has been linked to gastrointestinal health for decades. A clinical trial found prucalopride, another agonist of the target, accelerates gastrointestinal and colonic transit in patients with constipation more than 20 years ago and other teams have continued to build on the work.

First Wave has landed the chance to assess capeserod in the new indications by paying Sanofi an upfront fee of $500,000 and offering up to $281 million in milestones. Most, $235 million, of the milestones are tied to commercial events, with the rest linked to development and regulatory successes. The biotech ended June with $1.2 million, although it subsequently raised $2.1 million in a public offering.

Investor interest in the biotech has collapsed over the past year as doubts about its formulation of adrulipase have intensified, driving its share price down 98% to just 44 cents. First Wave has pitched the asset as a safer alternative to AbbVie’s Creon and other pig-derived pancreatic enzyme replacement therapies but has suffered setbacks in the clinic.