Fulcrum Therapeutics Ink pact with Sanofi To develop Losmapimod in FSHD

Fulcrum Therapeutics, Inc., a biotechnology firm, declared that it has signed a collaboration and license agreement with Sanofi to develop and commercialize losmapimod, an oral small molecule being studied for the treatment of facioscapulohumeral muscular dystrophy. Under the collaboration and license deal, Sanofi has exclusive commercialization rights for losmapimod outside of the United States.

The partnership and license agreement bring Fulcrum's FSHD expertise together with Sanofi's worldwide reach and unrivaled commitment to treating people with rare diseases. Losmapimod is now being studied in a global phase 3 clinical trial for the treatment of FSHD, a chronic and progressive hereditary muscular condition marked by substantial muscle cell loss and fat infiltration into muscle tissue. The results of ReDUX4, a phase 2 clinical trial testing losmapimod for the treatment of FSHD, revealed a slowing of disease progression and better muscle health. Fulcrum intends to announce topline results from REACH, the global phase 3 clinical study, in the fourth quarter of 2024. 

“Sanofi is a proven leader in developing therapeutics for rare neuromuscular diseases and is the ideal partner to maximize the opportunity and reach of losmapimod outside the US,” said Alex C. Sapir, Fulcrum’s president and chief executive officer. “This deal aligns with our core strategy, allowing Fulcrum to remain focused on preparations for commercialization of losmapimod in the US, while leveraging Sanofi’s exceptional global commercial capabilities and established infrastructure in key markets around the world. We are excited about the potential to provide the first approved treatment for FSHD patients, and we look forward to working with Sanofi to bring losmapimod to patients globally.”