Key Highlights
- Servier has signed a definitive agreement to acquire KER-0193 from Kaerus Bioscience, a potential first-in-disease treatment for Fragile X syndrome (FXS), the most common genetic cause of autism spectrum disorder (ASD).
- KER-0193 is an orally bioavailable small molecule modulator of BK channels, designed to correct abnormal signaling linked to the genetic cause of FXS.
- The candidate has completed a successful Phase 1 study in healthy volunteers, showing safety, tolerability, and favorable pharmacokinetics.
- The therapy has been granted Orphan Drug Designation and Rare Pediatric Disease Designation by the U.S. FDA.
- Deal value could reach $450M, including upfront and milestone-based earn-outs.
- Servier plans to initiate a Phase 2 clinical trial in 2026 across the U.S. and Europe.
Strategic Fit for Servier
This marks Servier’s first neurology asset acquisition, aligned with its 2030 strategy to expand beyond oncology and cardiometabolism into rare neurological diseases. With no approved treatments for Fragile X syndrome, KER-0193 represents a potential breakthrough in addressing an area of urgent unmet medical need.
Fragile X Syndrome: An Unmet Need
FXS is a rare genetic neurodevelopmental disorder that affects approximately 1 in 7,000 males and 1 in 11,000 females globally. It is the leading inherited cause of intellectual disability and the most common single-gene form of autism spectrum disorder. Currently, no approved therapies exist for FXS, underscoring the importance of advancing clinical innovation in this field.
About Servier
Servier is an independent, global pharmaceutical group governed by a non-profit foundation. Headquartered in France, Servier operates in 140 countries with more than 22,000 employees and reported revenues of €5.9 billion in 2023–24. The company reinvests all profits into innovation, focusing on oncology, cardiometabolism, rare diseases, and neurology. Its long-term ambition is to build differentiated therapies that address high unmet needs and create sustainable impact for patients worldwide.
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