Denali begins dosing Parkinson’s patients in Phase Ib trial

5th September 2019 (Last Updated December 23rd, 2019 09:33)

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

Denali begins dosing Parkinson’s patients in Phase Ib trial
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.

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.

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.