Biohaven Jumps into Parkinson’s Fight with Novel Drug, Targeting Neuroinflammation
NEW HAVEN, Conn., May 29, 2025 /PRNewswire/ — Biohaven Ltd. (NYSE: BHVN) is making a bold move in the fight against Parkinson’s disease, announcing the launch of a global Phase 2/3 clinical trial for its groundbreaking drug, BHV-8000. The investigational therapy, a first-in-clinic, orally administered, brain-penetrant, and highly selective TYK2/JAK1 inhibitor, aims to tackle the disease at its source: neuroinflammation and immune dysregulation.
* BHV-8000 is a first-in-clinic, brain-penetrant, and selective inhibitor of TYK2 and JAK1 kinases – a novel investigational therapy with the potential to treat the neuroinflammation and immune dysregulation that drives disease progression in Parkinson’s disease (PD)
* Currently, there are no approved disease-modifying therapies for the more than 10 million people living with PD
“We’re proud to initiate this pivotal trial for BHV-8000, a novel therapy with significant potential in treating neurodegenerative diseases,” stated Pete Ackerman, M.D., Senior Vice President of Clinical Development at Biohaven. “Parkinson’s is a relentlessly progressive neurological disorder, and the global prevalence is expected to double by 2050. With no existing therapies that truly modify the disease, the need for innovative solutions is critical.” Dr. Ackerman added that growing evidence points to immune dysregulation as a key factor in Parkinson’s disease. BHV-8000, by targeting TYK2 and JAK1, is designed to modulate critical inflammatory pathways which may result in neuronal loss in PD patients.
The Phase 2/3 study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of BHV-8000 at two dose levels. The trial’s innovative design incorporates a time-to-event primary endpoint analysis, leveraging changes in the MDS-UPDRS Part II, a benchmark accepted by the FDA to support registration. The trial will also utilize first-in-clinic Parkinson’s disease composite scales (PARCOMS), which may offer a more sensitive measure of changes in function. The study will enroll 550 patients across 13 countries, including the United States, Canada, and 11 European nations. For more details, visit www.clinicaltrials.gov/study/NCT06976268.
“Biohaven is developing BHV-8000, a novel investigational highly potent, brain-penetrant, and selective dual TYK2/JAK1 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases,” added Stuart Isaacson, MD, Director and Founder of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Medical Director of the Parkinson’s Research and Education Foundation, and Principal Investigator in the BHV8000-301 trial. Dr. Isaacson elaborates that TYK2 and JAK1 inhibition has shown promise in autoimmune and dermatologic disorders and are also implicated in neuroinflammation within the CNS. A potential benefit of BHV-8000 is that it may reduce the risk of serious toxicities associated with other JAK inhibitors.
The Phase 1 clinical program has demonstrated BHV-8000’s safety and tolerability, with no serious adverse events and no significant adverse trends observed. Furthermore, BHV-8000 has shown target engagement with significant reductions in inflammatory biomarkers. The drug’s pharmacokinetics show robust brain penetration, offering sustained coverage above therapeutic targets.
Dr. Ackerman emphasized the company’s commitment to the global Parkinson’s community and the collaboration with regulatory bodies like the FDA, adding, “We’re working to deliver a transformative therapy where none currently exists. For too long, patients and families have faced progressive neurodegenerative diseases with limited treatment options. Today marks a pivotal moment in our quest to advance science and bring hope to those most in need.”
**About BHV-8000**
BHV-8000 is a first-in-clinic, brain-penetrant, selective TYK2/JAK1 inhibitor, targeting conditions like early Parkinson’s disease, Alzheimer’s disease, and multiple sclerosis, as well as preventing ARIA in individuals undergoing anti-amyloid therapies. This dual inhibitor has the potential to target key signaling pathways involved in the progression of neurodegenerative diseases. Data thus far showcases the safety characteristics of BHV-8000 and the potential for an improved safety profile over other JAK2 and JAK3 inhibitors.
**About Biohaven**
Biohaven is a biopharmaceutical company focused on therapies in immunology, neuroscience, and oncology. The company is developing a portfolio of life-changing therapeutics, leveraging its drug development experience and proprietary platforms. Their broad clinical and preclinical programs include Kv7 ion channel modulation, extracellular protein degradation, TRPM3 antagonism, TYK2/JAK1 inhibition, glutamate modulation, myostatin inhibition and antibody-based therapies. For more information, visit www.biohaven.com.
**Forward-looking Statements**
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that these statements are not guarantees of future performance and involve risks. Actual results may differ materially.
MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.
Original article, Author: Jam. If you wish to reprint this article, please indicate the source:https://aicnbc.com/1236.html
