AXO-Lenti-PD is an investigational gene therapy being developed for the treatment of Parkinson’s disease. Credit: Colin Behrens from Pixabay.

Denali Therapeutics has started dosing patients in a Phase Ib clinical trial evaluating DNL151 for the treatment of Parkinson’s disease.

DNL151 is a small molecule leucine-rich repeat kinase 2 (LRRK2) inhibitor. LRRK2 regulates lysosomal function and its inhibition is expected to restore the impaired function and slow disease progression in Parkinson’s patients.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The multi-centre, randomised, placebo-controlled, double-blind Phase Ib study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of various oral doses of the drug candidate over 28 days.

In addition, target and pathway engagement biomarkers will be monitored, along with select exploratory clinical endpoints.

The trial will enrol around 24 mild to moderate Parkinson’s patients, irrespective of their genetic LRRK2 mutation status. Participants will be treated with a low or high dose of DNL151 or placebo.

“We are excited to evaluate DNL151 in Parkinson’s disease patients.”

Results from the Phase Ib trial are expected to be presented early next year.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

Denali Therapeutics CMO Carole Ho said: “Based on data generated from our prior study in healthy volunteer subjects, we are excited to evaluate DNL151 in Parkinson’s disease patients.

“We believe that this study will provide additional important safety and biomarker data in patients to inform the choice between either DNL151 or DNL201 for potential registrational trials.”

The company also announced the launch of a patient engagement website, EngageParkinsons.com, which offers information about the neurodegenerative disease.

The website also explains the biomarker-driven approach used by the company to discover and develop investigational drugs for patients with Parkinson’s. It also provides information on clinical trials being conducted by the company.

Besides DNL151, Denali is studying DNL201 for the treatment of Parkinson’s patients with and without LRRK2 mutations.

In February this year, the company started dosing in a separate Phase Ib study of DNL747 for Alzheimer’s disease patients.

Clinical Trials Arena Excellence Awards - Nominations Closed

Nominations are now closed for the Clinical Trials Arena Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Science 37 has won the Research and Development Award in the Site Innovation category for its FDA inspected Direct-to-Patient Site model, delivering nationwide access, faster enrollment and higher retention. Explore how its virtual-first, in home approach is reshaping trial operations and accelerating time to data-driven decisions..

Discover the Impact