UCB SA UNSP/ADR - UCBJY STOCK NEWS

UCB announced three-year data from the BE BRIGHT open-label extension study at the EADV Congress, showcasing the long-term efficacy of bimekizumab for moderate to severe plaque psoriasis. Key findings reveal that over 82% of patients maintaining complete skin clearance (PASI 100) and approximately 94% achieving low disease activity (PASI ≤2) after 16 weeks retained these results up to three years. Safety data from pooled Phase 2 and 3 trials indicated that bimekizumab was generally well tolerated, with no new safety signals reported, reinforcing its positive profile in treating psoriasis.

UCB announced its participation in the 31st European Academy of Dermatology and Venereology Congress in Milan, showcasing 20 abstracts focused on psoriasis and psoriatic arthritis. Key findings include three-year data from the BE BRIGHT study on bimekizumab for moderate to severe plaque psoriasis, highlighting long-term efficacy and safety. While bimekizumab has secured EU and other international approvals, it remains investigational in the U.S., with no FDA endorsement yet. UCB aims to elevate care standards for dermatological diseases through innovative therapies.

UCB announced positive 24-week results from two Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, demonstrating the efficacy of bimekizumab in treating axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis. The studies met primary and secondary endpoints, showing substantial improvements in symptoms versus placebo, with 47.7% and 44.8% of patients achieving the ASAS40 response, respectively. Bimekizumab's safety profile was consistent with prior studies. Further data will be presented at EULAR 2022 in Copenhagen.

UCB announced results from two Phase 3 studies, BE OPTIMAL and BE COMPLETE, evaluating bimekizumab for adults with active psoriatic arthritis. Both studies surpassed their primary endpoints with significant improvements at week 16: 43.9% of biologic-naïve patients and 43.4% of TNF-inadequate responders achieved ACR50 compared to 10.0% and 6.8% on placebo (p<0.001). Additionally, over 60% of bimekizumab-treated patients reached PASI90. The results will be presented at EULAR 2022 but safety and efficacy aren't established for regulatory approval.

UCB announced significant results from two Phase 3 studies of investigational treatments for generalized myasthenia gravis: zilucoplan and rozanolixizumab. Both showed statistically significant improvements in gMG-specific outcomes, with regulatory submissions expected later this year. The RAISE study found zilucoplan improved the Myasthenia Gravis Activities of Daily Living score by 2.12 points versus placebo (p<0.001). Similarly, the MycarinG study showed rozanolixizumab reduced symptoms significantly, with reductions in IgG levels. Both treatments were generally well-tolerated.

UCB announced the publication of a Phase 3 trial in JAMA Neurology, demonstrating that FINTEPLA (fenfluramine) significantly reduces drop seizure frequency in Lennox-Gastaut Syndrome (LGS) patients. The study met its primary endpoint, with a mean reduction of 19.9% in drop seizures compared to placebo (P=.001). FINTEPLA, recently approved by the FDA, is shown to be effective in patients suffering from generalized tonic-clonic seizures, addressing high morbidity associated with LGS. The treatment was well-tolerated, but monitoring for cardiovascular issues is required due to potential risks.

UCB's commitment to advancing treatments for serious neurological diseases is showcased through new data presented at the 74th American Academy of Neurology (AAN) Annual Meeting. This includes findings related to epilepsy and Parkinson's disease, highlighting the real-world effectiveness of BRIVIACT® in adults with partial-onset seizures, long-term use of FINTEPLA® for Lennox-Gastaut syndrome, and preclinical evaluation of the investigational treatment UCB0599 for Parkinson's disease. UCB also emphasizes its role in enhancing understanding of myasthenia gravis.

UCB announced that the FDA has approved FINTEPLA (fenfluramine) for treating seizures linked to Lennox-Gastaut syndrome (LGS)Dravet syndrome. LGS is a serious childhood-onset epilepsy affecting 30,000 to 50,000 patients in the U.S., characterized by drug-resistant seizures. The FDA approval is supported by a Phase 3 trial showing a significant median drop in seizure frequency of 23.7% with FINTEPLA. The medication is distributed through a restricted program due to safety risks, necessitating ongoing cardiac monitoring.

UCB presented 11 abstracts on bimekizumab for treating adults with moderate to severe plaque psoriasis at the 2022 American Academy of Dermatology Annual Meeting. Pooled data from five Phase 3/3b trials revealed that over 80% of patients who achieved complete skin clearance at week 16 maintained this response for two years. Notably, clinical responses improved for patients switching from secukinumab to bimekizumab. Bimekizumab is currently under FDA review, with its efficacy yet to be established in the U.S.