Neuroscience
The submission was completed with ongoing collaboration with the FDA and include data from the Phase III EMERGE and ENGAGE trials, as well as the Phase Ib PRIME study. Biogen has also requested Priority Review.
Biopharmaceutical companies need to look beyond the usual targets when addressing neurodegenerative disorders and also must work to correlate genetic changes to cognitive changes in patients, according to panelists at BIO’s on-demand session, “Battle of the Brains: Rethinking Neurodegenerative Disease Treatment.”
After Disappointing Study Results, Denali and Sanofi Shift Resources to a Different Alzheimer’s Drug
Denali Therapeutics and its development partner Sanofi announced data from its Phase Ib trial of DNL747 in Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).
The Phase II study will be performed in collaboration with the National Institutes of Health under a $2.7 million grant.
About 70% of AD patients have symptoms of agitation, which is marked by emotional distress, aggressive behaviors, disruptive irritability and loss of inhibition.
DIAN-TU-001 is a Phase II/III trial that tested two therapies compared to placebo, Genentech and Roche’s gantenerumab and Eli Lilly and Company’s solanezumab.
Investigators at the Case Western University School of Medicine identified a previously unknown gene and the resultant protein that may potentially slow the progress of Alzheimer’s disease.
Research conducted at Temple University is showing a potential new way to address the onset of Alzheimer’s disease through the use of pharmacological chaperones.
Novo Nordisk specializes in the diabetes market. The company appears to be making an entry into the Alzheimer’s market, which isn’t as unusual or unexpected as it initially sounds.
Biogen is buying a novel CNS-penetrate inhibitor of casein kinase 1 (CK1) from Pfizer to develop for patients with behavioral and neurological symptoms in various psychiatric and neurologic diseases.
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