Phase 3, the Lighthouse study, Biogen and Denali, LRRK2 inhibitor BIIB122; New clinical trial registered

New clinical trial registered: Biogen and Denaliti have initiated the 2nd late-stage study of their LRRK2 inhibitor BIIB122; Phase 3, randomized, double-blind, placebo-controlled efficacy & safety study in 400 individuals with LRRK2-associated #Parkinsons

clinicaltrials.gov/ct2/show...

twitter.com/ScienceofPD/sta...

This is the "Lighthouse study"; 225mg of BIIB122 (or placebo) tablets orally, once daily for up to 180 weeks; Primary endpoint = MDS-UPDRS II & III "Up to week 180"; Inclusion criteria = MDS-UPDRS II & III (in OFF state) combined score ≤40 at screening + LRRK2 variant

[Farooqji]

Thanks so much for sharing. This is one of very few trials that has entered into phase 3

[jimcaster]

From a Science of Parkinson’s post:

"On the 10th January of this year, Denali Therapeutics provided some details on their plans for the future development of BIIB122/DNL-151 (Click here to read the press release).

Specifically, they are planning two late stage clinical trials – which will be called LIGHTHOUSE and LUMA.

And these studies will be very different in their design.

The LIGHTHOUSE study will be a global Phase 3 clinical trial and it will be seeking to recruit 400 people with Parkinson’s who also carry a LRRK2 gene variant. These individuals will be treated with either BIIB122 or placebo for at least 96 weeks.

The LUMA study will be a large Phase 2b clinical trial of 640 people with Parkinson’s. Importantly, the study participants will NOT have any variant in the LRRK2 gene and the study treatment period of BIIB122 or placebo will be 48 weeks.

In both studies, clinical symptoms of participants will be assessed to determine whether there is a decrease in the rate of progression of Parkinson’s in those individuals treated with BIIB122."

Apparently, there is reason for cautious optimism even among us with idiopathic Parkinson's and not just for those with the LRRK2 mutation.

[jeffreyn]

Estimated Study Completion Date: January 2031

[Jana86 in reply to jeffreyn]

Eight years???? Seems as though they would have results sooner given the 48/96 week duration.

[jeffreyn in reply to Jana86]

For comparison, the Phase 2b (n=640) LUMA trial started in April 2022, and has an Estimated Study Completion Date of August 2025.

[jeffreyn in reply to jeffreyn]

Maybe they think it will take ages to recruit 400 PwPs with LRRK2 variant?

[Hidden in reply to Jana86]

omg

[Hidden in reply to Jana86]

I think max 4 years.

[Hidden in reply to jeffreyn]

Experimental: BIIB122 225 mgParticipants will receive 225 mg of BIIB122 tablets, orally, once daily (QD) for up to 180 weeks. - that is 3.4 years.

[Hidden]

I updated the title, added the Lighthouse study keyword