Bond.az -- Denali Therapeutics Inc (NASDAQ:DNLI) shares fell 2.9% in premarket trading Friday, while partner Biogen Inc (NASDAQ:BIIB) dropped 1%, after the companies announced their experimental Parkinson's disease treatment failed a late-stage clinical trial.
The Phase 2b LUMA study of BIIB122 (DNL151), an investigational LRRK2 inhibitor, did not meet its primary or secondary endpoints in individuals with early-stage Parkinson's disease. The drug failed to slow disease progression versus placebo, as measured by the modified Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II and III combined score.
Based on the results, Biogen and Denali will discontinue further development of BIIB122 in idiopathic Parkinson's disease. However, Denali will continue to independently conduct the Phase 2a BEACON study in carriers of a pathogenic LRRK2 variant, with data anticipated in the first half of 2027.
The LUMA study enrolled 648 people with early-stage Parkinson's disease between the ages of 30 and 80, who received BIIB122 or placebo for a minimum of 48 weeks and up to 144 weeks. While the drug demonstrated over 90% kinase inhibition of peripheral LRRK2 and approximately 30% reduction in a biomarker of LRRK2 activity in cerebrospinal fluid, these biological effects did not translate to clinical benefit. BIIB122 was generally well tolerated with an acceptable safety profile.
LRRK2 mutations account for 4% to 5% of familial and 1% to 2% of sporadic Parkinson's disease cases. The companies will present detailed findings from the LUMA study at an upcoming scientific conference.
Parkinson's disease affects approximately one million people in the U.S. and more than 10 million worldwide. The progressive neurodegenerative disorder is characterized by motor symptoms such as tremor, muscle stiffness, and slowness of movement, as well as non-motor symptoms including sleep disturbances and cognitive impairment.
