HIGH POINT, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) today reported baseline characteristics for the enrolled subjects in the ongoing Elevage clinical study of azeliragon as a potential treatment for mild Alzheimer’s disease (AD) in people with type 2 diabetes (NCT03980730). The data demonstrate that the patients enrolled in Elevage (n=43) have similar baseline characteristics to those in the STEADFAST A-study type 2 diabetes (T2D) subgroup (NCT02080364) (n=47). As the company reported in October 2018, data from this subgroup demonstrated nominally significant differences favoring azeliragon compared with placebo on the ADAS-cog11, an instrument used to evaluate cognition. The goal of the Elevage study is to confirm the results of these retrospective analyses in a 6-month Phase 2 study prior to initiating a Phase 3 study.
The Elevage data are being presented today at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) Conference - Digital Event, which is being held virtually November 4-7, 2020.
“We have completed enrollment in Part 1 of Elevage and are pleased that the baseline characteristics are consistent with those of the STEADFAST T2D subgroup in which we saw benefit for azeliragon compared with placebo,” said Steve Holcombe, President and CEO of vTv Therapeutics. “The Elevage study for azeliragon in this patient population is designed as sequential Phase 2 and 3 trials operationally conducted under one protocol. If the Phase 2 data are positive, this design would allow us to move quickly to a Phase 3 trial with the potential to support product approval. Approximately 35% of patients with AD have T2D, with associated increased advanced glycation endproducts and increased expression of the Receptor for Advanced Glycation Endproducts, the target for azeliragon. We believe that azeliragon could potentially be an important advance for addressing dementia in this population.”
Baseline characteristic data presented today demonstrate that the Elevage patient population is similar to that of the STEADFAST T2D subgroup with respect to age, height, weight, body-mass index, ApoE status, background AD medication, HbA1c, and scores on multiple cognitive assessments including Mini-Mental State Exam (MMSE), ADAS-cog11, CDR Global, and CDR Sum of Boxes. The company expects to report topline safety and efficacy data from Part 1 of the Elevage study in December 2020, earlier than previously anticipated.
Details of the CTAD digital presentation are:
Oral Presentation Title: “The Azeliragon Elevage Study: Study Update and Preliminary Data on Baseline Characteristics of Participants with Mild Alzheimer’s Disease and Type 2 Diabetes Randomized in Part 1”Presentation Number: LB5Category: On Demand, Late Breaking CommunicationsDate and Time: Wednesday, November 4, 2020, Available from 1 am US ESTAbout the Elevage Study
The Elevage Study is a randomized, double-blind, placebo-controlled clinical trial evaluating azeliragon in individuals ages 50 – 85 with probable mild-Alzheimer’s disease and type 2 diabetes. The objective of the Elevage Study is to replicate in a randomized double-blind, placebo controlled study the results observed in a post hoc analysis of the phase 3 STEADFAST trial A-Study in which a subgroup of forty-seven (47) patients with mild Alzheimer’s disease and type 2 diabetes treated with azeliragon demonstrated nominally statistically significant improvements in cognition on the ADAS-cog11 scale of 5.5 points (p=0.006) at month 18 compared to the same subgroup of patients treated with placebo. Azeliragon associated improvement was nominally significant as early as month 6 on the ADAS-cog11 scale (4.9 points, p