'Transformative Event' For First Wave BioPharma: License Agreement for Hopeful Gastrointestinal Candidate From Sanofi

First Wave BioPharma Inc FWBI announced an agreement with Sanofi SA SNY to license Capeserod, a selective 5-HT4 receptor partial agonist, which First Wave will repurpose and develop for gastrointestinal (GI) indications. 

The update follows First Wave BioPharma's disappointing topline results from its Phase 2 SPAN trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for exocrine pancreatic insufficiency in cystic fibrosis patients. 

Though initial data indicated that enhanced adrulipase formulation was safe and well tolerated, it was likely that the primary efficacy endpoint was not achieved. 

First Wave will receive an exclusive global license for Capeserod and assume responsibility for all future clinical development. 

The licensing agreement, which includes a modest upfront payment, backend milestone payments, and single-digit royalties on net sales, provides a right of first refusal for Sanofi to reacquire Capeserod following certain development stages and commercialize the product.

Sanofi's research on Capeserod and the subsequent artificial intelligence (AI)-empowered analyses suggest that the drug's mechanism of action has potential applications for several gastrointestinal disorders. 

Sanofi previously conducted seven Phase 1 and two Phase 2 trials investigating the potential of Capeserod for neurological disorders. 

In these trials involving over 600 patients, Capeserod appeared safe and well-tolerated. 

First Wave will immediately request a meeting with the FDA to establish a development and regulatory pathway for Capeserod in GI diseases with the intent to initiate clinical trials in 2024.

"Securing an exclusive, worldwide license from Sanofi for Capeserod is potentially a transformative event for First Wave that adds a drug with a well-documented safety profile to our GI-focused development pipeline," stated James Sapirstein, President and CEO of First Wave.

Price Action: FWBI shares are down 7.93% at $0.40 premarket on the last check Thursday. SNY shares closed at $54.28 closed at $0.44 on Wednesday.