BioVie подала заявку на встречу с FDA для запуска третьей фазы испытаний препарата от болезни Паркинсона

Компания BioVie Inc. направила в Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США запрос на проведение встречи по завершению второй фазы клинических исследований своего лекарства bezisterim. Фармпроизводитель планирует определить окончательный дизайн третьей фазы, ориентированной на пациентов с повышенным уровнем воспаления, и обсудить с регулятором иерархию конечных точек.

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BioVie advances Parkinson’s Phase 3 development program with FDA engagement

BioVie Inc ( NASDAQ:BIVI NASDAQ:BIVIW ) View Price & Profile BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) told investors that it is preparing to advance its Phase 3 development program for bezisterim in Parkinson’s disease and has requested an End-of-Phase 2 meeting with the US Food and Drug Administration. The company is working with Parkinson’s disease clinical development experts to finalize the design of a Phase 3 trial. BioVie expects MDS-UPDRS Part III, which measures motor symptoms, to serve as the primary endpoint, while MDS-UPDRS Part I, which assesses non-motor experiences of daily living, is expected to be included as a co-primary or secondary endpoint. “We are working closely with leading experts in Parkinson’s disease clinical development to finalize a Phase 3 trial design that includes MDS-UPDRS Part III as the primary endpoint, consistent with the FDA’s longstanding focus on motor symptom improvement in evaluating Parkinson’s therapies,” Joseph Palumbo, BioVie’s executive vice president of research and development and chief medical officer, said in a statement. Palumbo noted that Phase 2 results indicated that bezisterim’s potential clinical benefits may be more pronounced in non-motor symptoms, while patients with higher levels of inflammation appeared to derive greater benefit from treatment. BioVie plans to discuss with the FDA how MDS-UPDRS Part I should be incorporated into the endpoint hierarchy. The company expects the proposed enrichment strategy, which would target patients with higher levels of inflammation, could support a Phase 3 trial of approximately 175 patients. BioVie expects to discuss the proposed trial design with the FDA later this fall and anticipates receiving formal written feedback before the end of 2026. The planned development follows the SUNRISE-PD Phase 2 trial, a 12-week study involving 57 patients with early-stage Parkinson’s disease who had not previously received carbidopa/levodopa treatment. According to BioVie, patients treated with bezisterim who had elevated inflammatory markers, measured through platelet levels, showed statistically significant differences compared with placebo across MDS-UPDRS Parts I, II and III, as well as the total MDS-UPDRS score. The company noted that these exploratory findings require validation in a larger, longer-duration study. Bezisterim, also known as NE3107, is an investigational oral drug designed to cross the blood-brain barrier and modulate pathways associated with neuroinflammation and insulin sensitivity. Its safety and efficacy have not been established for any indication. BioVie is also evaluating bezisterim in other neurological conditions, including Long COVID and Alzheimer’s disease. The company expects topline data from its approximately 200-patient ADDRESS-LC trial in Long COVID in late summer 2026. Shares of BioVie were up around 5.6% on Tuesday morning.