HIGH POINT, N.C.--(BUSINESS WIRE)--vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered treatments for Alzheimer’s disease (AD) and diabetes, today announced that a subgroup analysis from the azeliragon Phase 3 STEADFAST trial was presented at the 11th Clinical Trials on Alzheimer’s Disease (CTAD) conference in Barcelona, Spain. The data presented at the conference included post-hoc, positive data indicating a potential benefit of treatment with azeliragon in AD patients with type 2 diabetes. It is estimated that nearly 40 percent of Medicare beneficiaries age 65 and older with dementia also have diabetes (Alzheimer’s Association. 2018 Alzheimer’s Disease Facts and Figures).
In a poster presentation titled “Is RAGE the missing link between diabetes and dementia? Results from a subgroup analysis of the STEADFAST trial,” researchers from vTv reviewed results from a post-hoc subgroup analysis from the company’s STEADFAST trial. This subgroup included 55 patients with type 2 diabetes (defined by glycosylated hemoglobin (HbA1c) of greater than 6.5% at baseline; HbA1c greater than 7.7% was an exclusion criterion at screening) and a clinical diagnosis of Alzheimer’s disease in the combined A-Study and B-Study of the STEADFAST trial. The azeliragon-treated group in the A-Study (n=18) demonstrated a 6.1 point benefit on ADAS-cog relative to the placebo group (n=8), which was nominally statistically significant (p = 0.005), and a 1.7 point benefit on CDR-sb relative to placebo (p = 0.08) after 18 months of treatment.
When conducting this subgroup analysis on pooled data from both the A-Study and B-Study and comparing change from baseline at 12 months (B-Study was discontinued at 12 months), the azeliragon subgroup (n=33) demonstrated a 3.5 point benefit on ADAS-cog (p = 0.01) relative to the placebo group (n=22), and a 0.7 point benefit on CDR-sb (p = 0.24) relative to placebo. A copy of the poster can be found on the publications page of the company’s website.
“The association between diabetes and dementia is well documented and these findings are supported by the mechanism of action of azeliragon. The Receptor for Advance Glycation Endproducts (RAGE) has been implicated in both the pathogenesis of Alzheimer’s disease and diabetic complications. These results, albeit from a smaller number of patients, reinforce this hypothesis and may open a new therapeutic approach for the treatment of not only dementia but also other complications of diabetes,” said Carmen Valcarce, Chief Scientific Officer of vTv Therapeutics.
“We are encouraged by the positive benefits experienced by the diabetic patients in this study.” said Steve Holcombe, Chief Executive Officer of vTv Therapeutics. “With over 400 million people with diabetes around the world who are at a higher risk of developing dementia, we think these findings warrant further investigation of this therapy for this unmet medical need,” added Mr. Holcombe.
Azeliragon, also known as TTP488, is an orally active small-molecule antagonist of the receptor for advanced glycation endproducts, RAGE. vTv Therapeutics discovered and developed azeliragon using its proprietary drug discovery platform, TTP Translational Technology®. A broad range of human pathologic and experimental biologic investigation suggests that RAGE ligand interactions lead to sustained inflammatory states that play a role in chronic diseases such as diabetes, inflammation, and Alzheimer’s disease.
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer’s disease and diabetes as well as treatment of inflammatory disorders.
The STEADFAST study, two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials (A-Study and B-Study), was designed to investigate the safety and efficacy of azeliragon as a potential treatment for patients with mild Alzheimer’s disease. The 18-month study targeted enrollment of 800 patients (400 in each trial). The first trial enrolled patients in the United States and Canada who had a clinical diagnosis of mild Alzheimer's disease and an MRI consistent with this diagnosis. Enrollment of the second trial included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa. 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.
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