Kaerus Bioscience Begins Phase 1 Trial for Fragile X Syndrome Drug KER-0193

Kaerus Bioscience Ltd., a biotechnology company based in London, UK, has announced the commencement of a Phase 1 clinical trial for KER-0193, its leading BK channel modulator aimed at treating Fragile X syndrome. Fragile X syndrome is recognized as the most common inherited cause of autism and intellectual disabilities, impacting over 1.5 million people globally. Notably, there are no existing approved treatments for Fragile X syndrome.

Robert Ring, PhD, the Chief Executive Officer of Kaerus Bioscience, emphasized the significance of this development, describing KER-0193 as a potential breakthrough in therapeutic approaches for Fragile X syndrome. He explained that the modulator was designed to address specific brain function breakdowns associated with the genetic underpinnings of Fragile X syndrome.

The Phase 1 trial, which is currently being conducted in Belgium, aims to evaluate the safety and tolerability of KER-0193 in healthy volunteers. This trial marks a pivotal milestone for Kaerus, representing over five years of research and development in BK channel modulators. The company's efforts have been bolstered by collaborations with academic institutions, clinical experts, and research foundations such as FRAXA.

Michael Tranfaglia, MD, Co-founder of the FRAXA Research Foundation, expressed enthusiasm for the BK channel targeting strategy, asserting that it could significantly improve the lives of those affected by Fragile X syndrome. He highlighted that KER-0193 is well-positioned to address this validated treatment target and suggested that this approach might also benefit a wide range of other neurodevelopmental disorders. Tranfaglia noted that FRAXA has extensively funded research on the hypo-function of BK channels in Fragile X, underscoring the potential value of BK channel modulators in treating this condition.

Ring further noted that the BK modulator program has provided Kaerus with a foundation to develop treatments for various other conditions, particularly genetic epilepsies. This platform offers clear opportunities for expanding therapeutic applications beyond Fragile X syndrome.

About KER-0193, it is described as a novel, proprietary, and orally bioavailable small molecule modulator of BK channels. Discovered by Kaerus, KER-0193 has shown significant efficacy in improving behavioral, sensory, and cognitive deficits relevant to Fragile X syndrome in genetic animal models. This provides a promising outlook for its potential impact on human patients suffering from the disorder.

In summary, the initiation of the KER-0193 Phase 1 clinical trial marks a significant advancement in the pursuit of effective treatments for Fragile X syndrome, offering hope to millions affected by this condition worldwide. Kaerus Bioscience's commitment to innovative therapeutic development continues to pave the way for potentially transformative treatments in the field of neurodevelopmental disorders.