vTv Therapeutics Announces Topline Results of Phase 2 Elevage Study of Azeliragon in Patients with Mild Alzheimer’s Disease and Type 2 Diabetes
vTv Therapeutics (Nasdaq: VTVT) has announced that its Phase 2 Elevage study of azeliragon for mild Alzheimer’s disease and type 2 diabetes did not meet its primary objective of improving cognitive function as measured by ADAS-cog14. The trial involving 43 participants showed a 1.8-point decline in the azeliragon group compared to 0.35 in the placebo group, with the differences not being statistically significant. Despite this, azeliragon was well-tolerated. The company will continue analyzing the data for future applications.
- Azeliragon was well-tolerated with similar adverse event rates as placebo.
- The company intends to analyze data for potential future applications of azeliragon.
- The primary objective of the study was not met, indicating potential challenges for future drug development.
- The cognitive decline in the azeliragon group was not statistically significant.
HIGH POINT, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) today announced that the Phase 2 Elevage study of azeliragon in people with mild Alzheimer’s disease and type 2 diabetes did not meet its primary objective of demonstrating an improvement in cognition as assessed by the 14-item Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog14) relative to placebo. The 6-month trial investigated the efficacy and safety of 5 mg azeliragon administered orally once daily compared to placebo in 43 people with mild probable Alzheimer’s disease and type 2 diabetes. The azeliragon treated group (n=21) had a 1.8 point decline from baseline in ADAS-cog14 compared to a placebo (n=22) decline of 0.35. These differences were not statistically significant. Consistent with previous studies, azeliragon was generally well-tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class in both treatment groups.
“We will continue to analyze the data to determine if there are potential benefits or future applications for azeliragon in Alzheimer’s, dementia or related indications that we or other interested parties may seek to pursue,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “On behalf of vTv Therapeutics, we would like to extend our most sincere and heartfelt gratitude to study participants, their families, physicians and caregivers for their commitment to this important study despite the challenging circumstances created by the COVID-19 pandemic.”
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimer’s and related dementia, and inflammatory disorders. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), genetic mitochondrial diseases, and chronic kidney disease. For more information, please visit www.vtvtherapeutics.com or follow us on Twitter: @vTvTherapeutics.
Forward-Looking Statements
This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.
Contacts
Investors:
Corey Davis
LifeSci Advisors
CDavis@LifeSciAdvisors.com
or
Media:
Glenn Silver
Lazar FINN Partners
646-871-8485
gsilver@lazarpartners.com
Source: vTv Therapeutics Inc.
FAQ
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