Denali Therapeutics Inc. (NASDAQ: DNLI) announced early on Thursday that it would be progressing its Parkinson’s treatment into late-stage studies, and investors cheered on this move. Also, Denali will be working in collaboration with the biotech giant, Biogen Inc. (NASDAQ: BIIB), for these studies.
Essentially, the company has selected DNL151 to progress into late-stage studies in Parkinson’s disease patients with a kinase activating mutation in LRRK2 and in sporadic Parkinson’s disease patients.
Note that LRRK2 is a regulator of lysosomal function, which is impaired in Parkinson’s disease and may be restored by LRRK2 inhibition. Mutations in the LRRK2 gene can cause Parkinson’s disease and are a major driver of lysosomal dysfunction, which plays into neurodegeneration.
So far, DNL151 has completed dosing of 162 healthy volunteers in an ongoing Phase 1 clinical study and 25 Parkinson’s patients in a Phase 1b clinical study. Denali is currently completing further dose escalation cohorts in an expanded Phase 1 and an additional cohort in the Phase 1b study.
An Investigational New Drug application for DNL151 was cleared by the U.S. Food and Drug Administration (FDA) in July, enabling expansion of these clinical studies for DNL151 globally.
Denali and Biogen are working to finalize the clinical development plans for the LRRK2 program and intend to commence two separate Parkinson’s disease studies, one in patients with a kinase activating mutation in LRRK2 and the other in patients with sporadic disease. Patient enrollment is expected to start in 2021.
Based on the totality of preclinical and clinical data to date, both DNL201 and DNL151 have met Denali’s requirements to proceed into further late-stage clinical studies. However, Denali selected DNL151 due to pharmacokinetic properties that provide additional dosing regimen flexibility.
Denali Therapeutics stock traded up about 36% to $31.72 on Thursday, in a 52-week range of $12.39 to $35.69. The consensus price target is $29.20.
Biogen stock traded at $276.12, in a 52-week range of $215.78 to $374.99. The consensus price target is $300.54.