ProMIS Neurosciences indicated that in January 2021, two important events transpired that it believes are quite positive for the Alzheimer's field, the updated amyloid hypothesis and for the company as well.
The first event occurred when Eli Lilly and Co. (LLY:NYSE) reported positive clinical results for its antibody donanemab on January 11, 2021. Eli Lilly's donanemab is the third therapeutic antibody that demonstrated positive clinical results in Alzheimer's disease that was designed to specifically target aggregated amyloid-beta (not amyloid monomer). Lilly's TRAILBLAZER trial included 272 subjects who were given donanemab, which targets pyroglutamated amyloid-beta that is known to be involved in toxic oligomer formation.
The second event was when the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee (PDUFA) date for review of Biogen Inc.'s (BIIB:NASDAQ) aducanumab to June 7, 2021, from March 7, 2021.
The date was pushed back by the FDA due to a negative non-binding advisory committee vote. Nonetheless, ProMIS feels that this is just a temporary setback and that it appears that the FDA review division strongly believes that the high dose of 10mg/kg aducanumab is clinically beneficial and warrants approval and that it expects that the FDA will grant approval for aducanumab in the summer of 2021.
ProMIS stated that each of these events offers very positive implications for the company and PMN310, its leading antibody therapeutic candidate for treating Alzheimer's disease developed to be highly selective for toxic oligomers. The company noted that there are now three programs showing clinical benefit due to the targeting of aggregated amyloid, which will likely impact toxic oligomers. The firm stated that the new collective clinical evidence serves to update the amyloid hypothesis supporting the view that ProMIS' PMN310 can be dosed higher and will likely avoid the ARIA-E side effect thus offering "best in class efficacy."
ProMIS Neurosciences' Executive Chairman Eugene Williams remarked, "Several analysts predicted that the FDA might manage its dilemma of believing that aducanumab should be approved despite a negative advisory committee vote by waiting for data to come in from the ongoing high dose extension study, extending the PDUFA date, and then approving the product later. It appears that prediction was correct...In line with this assessment, we believe the FDA will issue an approval of aducanumab in the summer of 2021."
ProMIS stated that it uses its unique core technology "to rationally predict the site and shape (conformation) of novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of proteins," and that in ALS, Alzheimer's and Parkinson's diseases, the DSEs are misfolded regions on toxic forms of otherwise normal proteins.[NLINSERT]
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