Alzheimer’s disease
Arkuda seeks to disrupt the usual progression of neurodegenerative disease with medicines developed by applying cutting-edge knowledge from the domains of lysosomal and microglial biology.
ALZ-801 is administered orally and works by blocking the formation of neurotoxic soluble amyloid oligomers that later lead to cognitive decline in Alzheimer’s patients.
The company indicated that its timeline for an accelerated approval request for its own Alzheimer’s drug, donanemab, was no longer on schedule for the first quarter after the CMS draft guidance.
Up to 40% of AD patients were found to have Lewy Bodies in their brain after succumbing to the disease.
Scientists believe that, perhaps, Alzheimer’s disease is a cause of not just beta-amyloid accumulation but, digging more deeply, immune system dysfunction.
Clinical trial news definitely picked up this final week of January. Here’s a look.
Alzamend Neuro is looking to commence a Phase II multiple ascending dose study of lead compound, AL001, in Alzheimer’s disease during the second quarter of this year.
Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
Cortexyme said it plans to provide additional updates pending further talks with the FDA.
Denali Therapeutics announced that the FDA had placed a clinical hold on the IND application for DNL919 and would receive an official clinical hold letter from the agency in about 30 days.
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