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

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.