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Servier's acquisition of KER-0193 marks a pivotal step in developing innovative treatments for Fragile X syndrome, enhancing its neurology pipeline.
The potential Fragile X syndrome treatment recently was granted both Orphan Drug Designation and Rare pediatric Drug Designation from FDA.
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Serveir announced it has entered a definitive agreement with Kaerus Bioscience, acquiring its potential Fragile X syndrome (FSX) treatment KER-0193. The agreement displays Serveir’s commitment to building a neurology franchise through expansion of its pipeline. Under terms of the agreement, Kaerus will receive an upfront payment for KER-0193 and will be eligible for development and commercial earn-out payments reaching upwards of $450 million.
Claude Bertrand, executive vice president of R&D at Servier, spoke on the definitive agreement, saying, "KER-0193 is Servier's first asset acquisition in neurology and so marks a significant milestone in our 2030 strategy, reinforcing our long-term commitment to establishing a leading neurology franchise focused on rare diseases. It reflects our determination to build a differentiated pipeline of innovative therapies for patients with underserved needs. We are particularly excited to advance KER-0193 as we believe it holds meaningful promise for patients living with Fragile X syndrome, a condition for which no approved treatment options exist today."1
KER-0193 was developed by Kaerus Bioscience as a potential SFX treatment (the most common genetic cause of autism spectrum disorder). Kaerus Bioscience successfully completed its Phase 1 clinical study of KER-0193 in healthy participants back in March of this year, confirming the treatments safety and tolerance with excellent pharmacokinetics. Additionally, KER-0193 was granted both Orphan Drug Designation and Rare Pediatric Drug Designations for the treatment of FXS by FDA.
KER-0193 is an orally bioavailable small molecule modulator of BK channels specifically addressing the abnormal function of BK channels linked to genetic causes of FXS.1 In its preclinical studies, KER-0193 displayed broad therapeutic-like abilities in improving syndrome-relevant behavioral, sensory, and cognitive deficits. 1 Preparation for its launch of a Phase II clinical trial, with a target year of 2026 for the treatment of FXS patients in both the U.S. and Europe, is part of Servier’s development strategy.
Dr. Robert Ring, chief executive officer of Kaerus Bioscience, commented on the partnership with Serveir and what it means for KER-0193, saying, "We strongly believe in the therapeutic potential of KER-0193 in Fragile X syndrome. Servier's firm commitment to neurology and global capabilities make it the ideal partner to further develop KER-0193 for patients worldwide."1
Who is Servier?
Servier is an independent international pharmaceutical company governed by a nonprofit organization and is committed to creating meaningful social impacts for its patients, along with providing contributions to building a sustainable world. The company’s governance model ensures independence while also support long term innovation with 100% of profits being reinvested into its development cycle.
Michèle Ollier, Venture Partner and co-founder of Medicxi, touched on Kaerus’ founding philosophies and its expectations for KER-0193’s development, saying, "Kaerus Bioscience was created by Medicxi to advance a clear product vision to develop a potential first-in-disease therapy for Fragile X syndrome. We are extremely proud of the cutting-edge scientific progress achieved by the Kaerus team under Dr Ring's leadership and are excited that this deal with Servier will accelerate the development of KER-0193, bringing us closer to ensuring this innovative new therapeutic can reach those patients who are most in need."1
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