UCB SA UNSP/ADR - UCBJY STOCK NEWS

UCB to present data on bimekizumab in hidradenitis suppurativa at symposium

UCB announces positive results from Phase 3 bimekizumab studies in hidradenitis suppurativa

The Child Neurology Society Meeting will showcase UCB's research on Dravet syndrome. A retrospective analysis showed that fenfluramine reduced healthcare utilization by 77% in individuals with Dravet syndrome, along with reductions in ER visits, outpatient visits, neurology visits, and inpatient hospitalizations. The survey highlighted challenges in early diagnosis and the importance of patient advocacy groups and online resources. These advancements in understanding and managing Dravet syndrome are positive for UCB.

UCB's RYSTIGGO® (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients. The approval is based on a Phase 3 study that showed significant improvements in gMG-specific outcomes. RYSTIGGO® is the only FDA-approved treatment for both anti-AChR and anti-MuSK antibody-positive gMG.

UCB announced its participation in the 75th American Academy of Neurology Annual Meeting from April 22-27, 2023, showcasing its neurology portfolio. The company will present 12 abstracts, including two oral presentations on treatments for generalized myasthenia gravis (gMG) and epilepsy syndromes like Lennox-Gastaut syndrome (LGS). Highlights include findings from the MycarinG and RAISE studies, detailing efficacy and safety of investigational treatments rozanolixizumab and zilucoplan for adults with gMG. UCB will also feature analyses on BRIVIACT and FINTEPLA, focusing on their impacts on seizure frequency and cognitive functions. Key sessions include a panel on seizure emergencies and cluster identification in adults, emphasizing UCB's commitment to improving patient outcomes in neurology.

UCB announced that the U.S. Drug Enforcement Administration has descheduled FINTEPLA oral solution, removing it from controlled substances classification effective immediately. This allows prescribers to issue prescriptions for a full year instead of six months, enhancing patient access to treatment for Dravet syndrome and Lennox-Gastaut syndrome. The company will update relevant state compendia accordingly. FINTEPLA, FDA-approved for patients aged 2 and older, is developed by UCB following their acquisition of Zogenix, Inc. in March 2022. The descheduling is expected to ease prescription processes for patients and caregivers, potentially increasing the drug’s usage for those in need.

UCB reported promising results from two Phase 3 studies (BE HEARD I and II) on bimekizumab, an IL-17A and IL-17F inhibitor, for treating moderate to severe hidradenitis suppurativa (HS). At week 16, patients receiving bimekizumab experienced statistically significant improvements in HS symptoms compared to placebo, with HiSCR50 responses at 47.8% and 52.0% in BE HEARD I and II, respectively. The efficacy persisted to week 48, with over 75% of patients achieving HiSCR50. UCB plans to submit global regulatory applications for bimekizumab in HS in Q3 2023. No new safety signals were noted, with common adverse events including hidradenitis and oral candidiasis.

UCB announced the presentation of eight abstracts on bimekizumab at the 2023 AAD Annual Meeting in New Orleans from March 17-21. This includes a late-breaking oral presentation detailing results from two Phase 3 studies, BE HEARD I and II, focusing on the treatment of moderate to severe hidradenitis suppurativa. The findings will help advance treatment options for chronic diseases. UCB's Executive VP emphasized the company's commitment to enhancing dermatological care. Although bimekizumab is not approved by the U.S. FDA, it has been approved in the EU for moderate to severe plaque psoriasis since August 2021.