#France #Servier #Fragile X Syndrome #Suresnes #KER-0193

Introduction

In a significant move to bolster its neurology pipeline, Servier, an international pharmaceutical group governed by a foundation, has announced its acquisition of KER-0193. This potential treatment addresses Fragile X syndrome, the most prevalent genetic cause of autism spectrum disorder (ASD), marking a pivotal step in Servier's strategy towards developing innovative therapies in neurology.

About the Acquisition

The definitive agreement between Servier and Kaerus Bioscience, the developer of KER-0193, highlights Servier's commitment to expanding its offerings for rare neurological conditions that currently lack effective treatment options. KER-0193 is an oral small molecule, which has benefitted from orphan drug designation and rare pediatric disease designation from the U.S. Food and Drug Administration (FDA), underscoring its potential importance in treating this challenging condition.

The acquisition was solidified following the successful completion of a Phase 1 clinical trial conducted on healthy volunteers in March 2025, which demonstrated the safety, tolerability, and excellent pharmacokinetics of KER-0193.

Financial Terms

Under the terms of the agreement, Kaerus Bioscience will receive an upfront payment for the rights to KER-0193, with additional payments related to its future development and commercialization. The total transaction value could potentially reach $450 million, reflecting the anticipated significance of KER-0193 in the market.

Significance of KER-0193

Claude Bertrand, Servier's Executive Vice President of R&D, articulated that this acquisition is a critical milestone that indicates Servier’s dedication to establishing a leading position in neurology focused on rare diseases. He expressed excitement about the possibility that KER-0193 could provide therapeutic benefits for patients with Fragile X syndrome, given that no approved treatments are currently available for this condition.

Moreover, Dr. Robert Ring, CEO of Kaerus Bioscience, emphasized the potential of KER-0193 as a therapeutic solution for Fragile X syndrome, noting Servier's strong commitment to neurology and its capabilities as the ideal partner for the drug's further development.

Clinical Development and Future Prospects

KER-0193 represents a breakthrough in the management of Fragile X syndrome, which is characterized by various cognitive and behavioral challenges. It affects approximately 1 in 7,000 men and 1 in 11,000 women globally, making it the leading genetic cause of intellectual disabilities and a major contributor to autism spectrum disorders.

Preclinical studies have already indicated that KER-0193 could significantly alleviate behavioral, sensory, and cognitive deficits associated with this condition. Servier plans to initiate a Phase 2 clinical trial in 2026, targeting patients with Fragile X syndrome across both the Americas and Europe, thereby taking meaningful steps towards bringing this innovative therapy to market.

Conclusion

The landscape of treatments for rare neurological disorders is gradually evolving, thanks to strategic acquisitions like that of KER-0193 by Servier. This move not only highlights the company's commitment to addressing unmet medical needs but also signals a broader shift in how pharmaceutical companies approach the development of therapies for vulnerable patient populations. As Servier continues to prioritize its research efforts and investment in rare diseases, it stands poised to potentially change the lives of those affected by Fragile X syndrome and other underserved conditions.