First Wave BioPharma licenses Sanofi’s Capeserod for gastrointestinal disorders

First Wave BioPharma (FWBI) announced an agreement with Sanofi (SNY) to license Capeserod, a selective 5-HT4 receptor partial agonist, which First Wave will repurpose and develop for gastrointestinal indications. First Wave will receive from Sanofi an exclusive, global license for Capeserod and will 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 stages of clinical development and to commercialize the product. Sanofi’s research on Capeserod and the subsequent AI-empowered analyses suggest that the drug’s mechanism of action has potential applications for several gastrointestinal disorders in multibillion-dollar markets. 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.