DNL-151
- Generic Name
- DNL-151
Denali Therapeutics' Tividenofusp Alfa Receives FDA Breakthrough Therapy Designation for Hunter Syndrome
• Denali Therapeutics' tividenofusp alfa (DNL310) has received Breakthrough Therapy Designation from the FDA for Hunter syndrome (MPS II).
• The designation aims to expedite the development and review of tividenofusp alfa, a potential improvement over existing therapies.
• Denali plans to submit a Biologics License Application (BLA) in early 2025 for accelerated approval of tividenofusp alfa.
• Tividenofusp alfa is designed to address both neurological and physical symptoms of Hunter syndrome by crossing the blood-brain barrier.
Denali Therapeutics Initiates Phase 2a Trial of BIIB122 for LRRK2-Associated Parkinson's Disease
• Denali Therapeutics has dosed the first participant in its Phase 2a BEACON study of BIIB122, a LRRK2 inhibitor, for LRRK2-associated Parkinson's disease.
• The BEACON study will assess the safety and biomarker effects of BIIB122 in approximately 50 participants with LRRK2-related Parkinson's.
• BIIB122 is also under investigation in the Phase 2b LUMA study for early-stage Parkinson's, with or without LRRK2 mutation, in collaboration with Biogen.
• LRRK2 inhibition targets lysosomal dysfunction, potentially modifying the course of Parkinson's disease rather than just treating symptoms.
Parkinson's Drug DNL-151 Phase III Trial Terminated; Lerodalcibep Shows Promise in Hypercholesterolemia
• Denali Therapeutics' DNL-151 Phase III trial for Parkinson's disease was terminated, leading to a 14-point decrease in its Likelihood of Approval (LoA).
• LIB Therapeutics' lerodalcibep showed positive Phase III data in heterozygous familial hypercholesterolemia (HeFH), increasing its LoA by 11 points to 65%.
• AstraZeneca's MEDI-7352 Phase IIb trial in osteoarthritis pain was completed, resulting in a six-point increase in its Phase Transition Success Rate (PTSR) to 45%.
• Incyte's itacitinib saw its PTSR increase in cytokine release syndrome (CRS) after a Phase II trial completion, jumping by nine points to 60%.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath