BIIB-Partnered LUMA Study Misses; BIIB122 Development In Idiopathic PD Ended

Research evidence excerpt

BIIB-Partnered LUMA Study Misses; BIIB122 Development In Idiopathic PD Ended

broader idiopathic PD

market.

DNLI continues to conduct the Ph. IIa BEACON study of BIIB122 in patients that are specifically

carriers of the pathogenic LRRK2 variant, with data expected in H1:27. We look forward to

detailed data from the LUMA study to determine if there was a signal of activity in patients

enrolled with LRRK2 mutations to better determine POS for the BEACON readout. Most of the

focus for DNLI investors has been on the Avlayah launch and the progress of the company's

TV platform across lysosomal storage and neurological diseases. Thus, we don't anticipate

meaningful downside following this evening's release, given that the event was more off the

radar and upside skewed in our opinion.

BIIB122/DNL151 Will Continue In Enriched BEACON Study

LUMA was a Ph. IIb multi-center, randomized, double-blind, placebo-controlled study to

evaluate the safety and efficacy of BIIB122/DNL151 compared to placebo in n=648 patients

with early stage Parkinson's Disease (including patients with and without pathogenic LRRK2

variants). Patients were treated for a minimum of 48 weeks and up to 144 weeks. The study did

not meet its primary endpoint with DNL151 failing to slow progression of Parkinson's disease as

measured by the primary endpoint of MDS-UPDRS Part II and III combined score. Secondary

endpoints also did not show a benefit, which included functional and clinical measures of

mSE-ADL and change from baseline in MDS-UPDRS Parts I, II, and III combined score over the

treatment periods.

The study did support pharmacologic target engagement. Exploratory biomarker analyses

demonstrated greater than 90% inhibition of peripheral LRRK2 kinase activity as measured by