Swiss Health Valley Biotechs Advance Drug Pipelines with Promising Clinical Milestones
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Three innovative biotech companies based in Western Switzerland, Stalicla, Legacy Healthcare and iOnctura, have recently achieved significant progress in their therapeutic pipelines, reinforcing the region’s position as a hub for health innovation.
STALICLA: Advancing Precision Medicine for Autism
Geneva-based STALICLA has received the green light from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2b clinical trial for STP1, its precision medicine candidate for Autism Spectrum Disorder (ASD). This decision followed a successful Type C meeting with the FDA. STP1 represents a new class of targeted therapeutics tailored to neurodevelopmental subtypes with high unmet medical need. The trial will be a crucial step in validating STALICLA’s approach to stratified treatments in ASD.
Legacy Healthcare: First-in-Class Topical Treatment for Alopecia Areata
Legacy Healthcare, based in Lausanne, announced that its Cinainu cutaneous solution showed significant efficacy and safety in children and adolescents with moderate to severe alopecia areata (AA). Results from the Phase 2/3 RAAINBOW trial, now published in the British Journal of Dermatology, demonstrate sustained hair regrowth without the immunosuppression-related side effects commonly seen with oral JAK inhibitors. This could offer a much-needed alternative for pediatric patients suffering from this autoimmune disease, which greatly impacts quality of life.
iOnctura: Targeting Rare Eye Cancer with Novel Allosteric Modulation
iOnctura, headquartered in Geneva, has dosed the first patient in its randomized Phase II OCULE-01 study, evaluating roginolisib, an allosteric modulator of PI3Kδ, in metastatic uveal melanoma (UM). The compound has received Orphan Drug Designation from both the European Medicines Agency (EMA) and the U.S. FDA. The trial aims to confirm early signals of clinical benefit and improved survival shown in the Phase I study. If successful, roginolisib could become a first-in-class, non-immunosuppressive treatment for this rare and aggressive cancer.
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From neurodevelopmental disorders and autoimmune diseases to rare cancers, Swiss Health Valley startups are making significant strides toward addressing some of the world’s most pressing medical challenges.
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