IN APRIL 2018
vTv Therapeutics Announces Topline Results from the First STEADFAST Phase 3 Study Evaluating Azeliragon in People with Mild Alzheimer’s Disease
HIGH POINT, N.C.--(BUSINESS WIRE)--Apr. 9, 2018-- vTv Therapeutics, Inc. (vTv) (Nasdaq:VTVT) today announced that results from Part A of the Company’s Phase 3 STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer’s disease did not meet either co-primary efficacy endpoint. Patients taking azeliragon compared with placebo did not improve in cognitive or functional outcomes as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb).
IN JUNE 2018
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vTv Therapeutics Announces Topline Results from Part B of Phase 3 STEADFAST Study
HIGH POINT, N.C.--(BUSINESS WIRE)--Jun. 12, 2018-- vTv Therapeutics Inc. (Nasdaq:VTVT) today announced that results from Part B of the Company’s STEADFAST Study of the investigational medication azeliragon in people with mild Alzheimer’s disease did not meet co-primary efficacy endpoints. The prespecified subgroup consisted of azeliragon-treated patients with maximal azeliragon plasma concentrations of less than 7.5 ng/mL and baseline Mini Mental State Examination (MMSE) scores between 19 and 27, and the endpoints were statistically significant improvement in cognitive or functional outcomes as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) at 12-months compared to placebo.
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However, consistent with findings in Part A and the Phase 2b trial, lower maximal plasma concentrations of azeliragon in Part B were associated with improvements in efficacy relative to placebo.
“We are eager to obtain early feedback from the FDA based on the results we have achieved and the data that we have observed associating lower plasma levels of the drug and improved efficacy,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “As a result, we believe that azeliragon has the potential to address the pressing unmet need in Alzheimer’s disease.”
While in April and in June 2018 topline results were announced that the A-Study and the B-Study did not meet the co-primary endpoints and clinical trials were ended, subsequent post-hoc subgroup analyses have shown populations that experienced positive benefits.
SO WE ARE WAITING FOR THE RESULTS OF THESE SUB-GROUP
