Biogen and Denali Therapeutics have initiated dosing in the international Phase IIb Luma clinical trial of BIIB122 (DNL151) in subjects with early-stage Parkinson’s disease.

Denali discovered and developed BIIB122, which is an investigational selective, central nervous system-penetrant small molecule LRRK2 inhibitor.

Hindering LRRK2 is a new approach designed to act on the underlying biological pathway linked to Parkinson’s disease.

Currently, the companies are jointly developing and marketing the therapy to potentially treat Parkinson’s disease. 

The placebo-controlled, multicentre, double-blind, randomised trial will analyse the safety and efficacy of BIIB122 in nearly 640 individuals aged between 30 and 80 years with early-stage Parkinson’s disease. 

In the trial, subjects will be randomised to receive either a once-a-day dose of oral BIIB122 or a placebo.

The Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment duration will be the primary endpoint of the trial. 

Denali chief medical officer Carole Ho said: “More than ten million people worldwide are affected by Parkinson’s disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease. 

“Initiation of the LUMA study marks an important milestone in the development of BIIB122 as a potentially first-in-class oral LRRK2 therapy for Parkinson’s disease. 

“We look forward to continuing our collaboration with Biogen and the Parkinson’s community in our unified goal to develop BIIB122 as a potential treatment option for people and families living with Parkinson’s disease.”

Apart from the Phase IIb LUMA trial, BIIB122 is being analysed in the Phase III LIGHTHOUSE trial in Parkinson’s disease patients with LRRK2 pathogenic variants.

In March this year, Denali commenced dosing of participants in a Phase I/II trial of DNL593 for the treatment of frontotemporal dementia-granulin.