Losmapimod is currently being tested in a global Phase 3 clinical trial for the treatment of FSHD with topline data anticipated to be released in Q4 2024

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Fulcrum Therapeutics secures up to $1.05bn agreement with Sanofi for FSHD candidate losmapimod. (Credit: Sanofi, Rookwood Way by Hugh Venables/Wikimedia Commons)

Fulcrum Therapeutics has signed a collaboration and licensing deal worth up to $1.05bn for the development and commercialisation of its oral small molecule losmapimod with Sanofi.

Losmapimod is being evaluated as a treatment option for facioscapulohumeral muscular dystrophy (FSHD) by Fulcrum Therapeutics.

Listed on the Nasdaq, the clinical-stage biopharmaceutical company is engaged in developing small molecules to address genetically defined rare diseases.

Under the terms of the agreement, Fulcrum Therapeutics will receive an upfront payment of $80m and could earn up to an additional $975m through specified regulatory and sales-based milestones.

Additionally, the company will receive tiered escalating royalties starting in the low-teens on losmapimod’s yearly net sales outside the US.

Furthermore, Fulcrum Therapeutics and Sanofi will equally share future global development costs.

Fulcrum Therapeutics president and CEO Alex Sapir said: “Sanofi is a proven leader in developing therapeutics for rare neuromuscular diseases and is the ideal partner to maximise the opportunity and reach of losmapimod outside the US.

“This deal aligns with our core strategy, allowing Fulcrum to remain focused on preparations for commercialisation of losmapimod in the US, while leveraging Sanofi’s exceptional global commercial capabilities and established infrastructure in key markets around the world.”

Losmapimod is currently being tested in a global Phase 3 clinical trial for the treatment of FSHD. Results from ReDUX4, the Phase 2 clinical trial for losmapimod in FSHD, showed a slowing of disease progression and improved muscle health.

Fulcrum Therapeutics expects to release topline data from the Phase 3 REACH clinical trial in Q4 2024. If the Phase 3 trial yields positive results, Fulcrum Therapeutics and Sanofi plan to submit marketing applications in the US, Europe, Japan, and other regions.

Sanofi rare diseases global head Burcu Eryilmaz said: “This partnership provides an exciting opportunity to expand Sanofi’s rare disease franchise and deliver the first approved FSHD treatment to patients with the strength and reach of our commercial organisation.

“Losmapimod has shown meaningful clinical benefits that underscore the disease-modifying potential and opportunity to address the high unmet need for a safe and effective drug that slows disease progression.”

In a separate announcement, Sanofi said that it will invest over €1bn to set up new bioproduction capacity at its sites in Vitry-sur-Seine, Le Trait, and Lyon Gerland in France.