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Denali Therapeutics Inc. develops medicines for neurodegenerative diseases, lysosomal storage disorders and other serious diseases using its proprietary TransportVehicle™ platform, which is designed to deliver biotherapeutics across the blood-brain barrier. Company news centers on AVLAYAH™ (tividenofusp alfa-eknm), an FDA-approved enzyme replacement therapy for Hunter syndrome (MPS II), and on pipeline programs that use enzyme, protein, oligonucleotide and antibody transport technologies.
Recurring updates cover clinical and preclinical data for programs in Sanfilippo syndrome type A, Pompe disease, Alzheimer’s disease, frontotemporal dementia and Parkinson’s disease, as well as regulatory decisions, conference presentations, collaboration changes, commercial launch activity and quarterly financial results.
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Denali Therapeutics Inc. (DNLI) and Biogen Inc. have entered a significant collaboration with Biogen exercising its option to license Denali's Antibody Transport Vehicle (ATV):Amyloid beta program (ATV:Aβ) aimed at Alzheimer’s treatment.
The ATV technology is designed to enhance the delivery of therapeutic antibodies across the blood-brain barrier, potentially improving efficacy against amyloid beta plaque, a key feature of Alzheimer’s disease. Following this agreement, Biogen will manage all development and commercialization efforts related to the program, while Denali will receive an option exercise payment and may earn milestone payments and royalties based on future sales. This collaboration builds on the partnership initiated in 2020.
Denali Therapeutics announced promising data for DNL343, an investigational treatment for amyotrophic lateral sclerosis (ALS), indicating it is well-tolerated, effective in inhibiting stress response biomarkers, and supports once-daily dosing.
The company plans to initiate the Phase 2/3 HEALEY ALS Platform Trial for DNL343 in mid-2023, following a successful 28-day Phase 1b study involving 29 ALS patients. The upcoming results will be showcased at the American Academy of Neurology annual meeting on April 25, 2023.
DNL343 aims to enhance eIF2B activity, potentially preventing ALS progression by improving protein synthesis and neuronal health. The HEALEY trial is a collaborative effort to test multiple therapies simultaneously to expedite ALS treatment development.