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vTv Therapeutics Reports 2018 First Quarter Financial and Operational Results and Recent Highlights
HIGH POINT, N.C. – (BUSINESS WIRE) – May 15, 2018 –vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial and operational results for the first quarter that ended March 31, 2018.
“We continue to make progress on all of our major programs”, said Steve Holcombe, chief executive officer, vTv Therapeutics. “While our initial readout of the results of our STEADFAST Part A Study was not what we had hoped for, we are pleased with the results of our subgroup analysis and are continuing our work in preparation for the Part B readout with a new prospectively-defined target population. We also are continuing to move our diabetes compounds into Phase 2 studies. Our GKA activator is now enrolling patients in a Phase 2 trial for type 1 diabetes and we expect interim results by year-end. We also continue to work with Huadong Medicine in China on the commencement of a Phase 2b study for our GLP-1r compound to test lower dosing levels. We remain enthusiastic for the success of these programs.”
Pre-specifying New Subgroup with the FDA for Part B Readout Expected in June
Last week, the company announced that, based on post hoc analyses of the data from Part A of the company’s Phase 3 STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer’s disease, despite not meeting co-primary endpoints, it had identified a subpopulation that showed statistically significant benefit (unadjusted for multiple post hoc comparisons) from azeliragon relative to placebo on ADAS-cog. The identified subpopulation consisted of participants with peak azeliragon blood plasma concentration of less than 7.5 ng/mL.
Based on the subpopulation data analyses from the Part A Study and the prior azeliragon trials, the company will submit a revised Statistical Analysis Plan (SAP) to the Food and Drug Administration for the Part B Study that pre-specifies a target population for the primary study analysis and expects to report Part B topline efficacy results based on 12 month data in June 2018.
The patients in the identified subgroup (n=~48) had a -1.9 point improvement in ADAS-cog relative to the placebo group (n=200) which was statistically significant (unadjusted for multiple post hoc comparisons) (p = 0.02), and a 0.5 point improvement on CDR-sb relative to placebo (p = .06) despite the smaller sample size.
First Quarter 2018 Financial Results
Cash Position: Cash and cash equivalents as of March 31, 2018, were $6.5 million compared to $11.8 million as of December 31, 2017.
The following information was filed by Vtv Therapeutics Inc. (VTVT) on Tuesday, May 15, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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