Biopharmaceutical company Denali Therapeutics Inc. (DNLI:NASDAQ), which is focused on developing a broad portfolio of product candidates for treatment of neurodegenerative diseases, today announced that "DNL151 has been selected 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."
The company's Chief Medical Officer Carole Ho, M.D., commented, "Safety and biomarker data from studies of our two LRRK2 molecules in Parkinson's patients support moving DNL151 into late stage clinical studies with the aim of addressing the devastating clinical decline and pathology of disease in Parkinson's patients...Our collaboration partner Biogen is a respected leader in neurodegenerative diseases and brings deep scientific and development expertise in Parkinson's disease which will allow us to accelerate our development plan and we believe increase the likelihood of ultimate success."
The firm explained that "LRRK2 is a regulator of lysosomal function, which is impaired in Parkinson's disease and may be restored by LRRK2 inhibition." The company noted that mutations in the LRRK2 gene can cause Parkinson's disease and are a leading driver of lysosomal dysfunction which often exacerbates neurodegeneration.
The company advised that it is working with its partner Biogen Inc. (BIIB:NASDAQ) in order to finalize clinical development plans for the LRRK2 program. The plans entail the commencement of two separate Parkinson's disease studies starting in 2021. The first study will be for use in patients with a kinase activating mutation in LRRK2 and the second trial in other patients with sporadic disease.
The firm stated that its two CNS-penetrant small molecules DNL201 and DNL151 inhibit LRRK2 and are currently in ongoing clinical studies. The company noted that "DNL 201 has successfully completed a Phase 1 study in 122 healthy volunteer subjects and a Phase 1b study in 28 Parkinson's disease patients." The firm noted that DNL201 has been generally safe and well tolerated allowing it to be advanced into further clinical studies.
The company also reported that "DNL151 has successfully completed dosing of 162 healthy volunteers in an ongoing Phase 1 study in healthy volunteer subjects and completed dosing in 25 Parkinson's disease patients in a Phase 1b clinical study."
Denali Therapeutics is a biopharmaceutical company headquartered in South San Francisco, Calif., that is engaged in developing a portfolio of product candidates to treat patients with neurodegenerative diseases including Alzheimer's disease, amyotrophic lateral sclerosis (ALS) and Parkinson's disease. The firm endeavors to apply deep scientific methodology and drug development expertise to discover effective molecular therapeutics and reports that it has engineered proprietary technology capable of effectively delivering biologic therapeutics to the brain.
Denali Therapeutics started off the day with a market capitalization of around $2.5 billion with approximately 105.6 million shares outstanding and a short interest of about 9.3%. DNLI shares opened nearly 31% higher today at $30.43 (+$7.19, +30.94%) over yesterday's $23.24 closing price and before climbing to a new 52-week high price this morning of $35.70. The stock has traded today between $30.31 and $35.70 per share and is currently trading at $31.89 (+$8.65, +37.22%).[NLINSERT]
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