Kaerus Bioscience Ltd. (www.kaerusbio.com), a clinical-stage biotechnology company focused on developing therapeutics for rare genetic syndromes of neurodevelopment, today announced that it has initiated a Phase 1 clinical trial of KER-0193, its lead BK channel modulator being developing for Fragile X syndrome. Fragile X syndrome is the most common inherited cause of autism and intellectual disability globally, affecting over 1.5 million individuals globally. There are currently no approved treatments for Fragile X.

“Kaerus’ BK modulator program is a potential game-changer in field of therapeutics development for Fragile X syndrome,” declared Ring, adding that, “Our lead BK modulator KER-0193 was developed to specifically address a breakdown in brain function uniquely tied to the genetics of Fragile X syndrome.”

“The start of our Phase 1 program for KER-0193 represents an exciting milestone for Kaerus, culminating over 5 years of R&D investment in BK channel modulator discovery and enabled by strong partnerships with academic collaborators, clinical experts and research foundations such as FRAXA,” said Robert Ring, PhD, Chief Executive Officer, Kaerus Bioscience.

Michael Tranfaglia, MD, Co-founder of the FRAXA Research Foundation notes: “We are very excited about the therapeutic strategy of targeting BK channels, and believe it can make a significant difference in the lives of people with fragile X,” adding that, “Kaerus’ lead molecule KER-0193 is in an excellent position to address this well-validated treatment target in Fragile X. I am also quite convinced that this treatment approach may be of value in a great many other neurodevelopmental disorders. FRAXA has funded an enormous amount of research over many years focused on the hypo-function of BK channels in fragile X, and the potential value of BK channel modulators to treat this condition.”

The Phase 1 clinical trial, being conducted in Belgium, will investigate the safety and tolerability of KER-0193 in healthy volunteers and is expected to complete in 2025.

Ring added, “The BK modulator program of Kaerus has also provided the company with a platform to further develop treatments for a variety of additional indications, with clear opportunities in a range of genetic epilepsies.”

About KER-0193KER-0193 is a novel, proprietary, and orally-bioavailable small molecule modulator of BK channels discovered by Kaerus. KER-0193 has already demonstrated broad effects on improving syndrome-relevant behavioral, sensory and cognitive deficits observed in genetic animal models of Fragile X.

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