NEW YORK, NY / ACCESSWIRE / May 11, 2018 / vTv Therapeutics and ARCA biopharma were both soaring in Thursday's trading session. Both had news as catalysts to drive shares higher with vTv Therapeutics announcing that the company will pre-specify new subgroup with the FDA and report phase 3 part B results in June. ARCA biopharma announced that Phase 2B Genetic-AF Clinical trial results were selected for a late breaking oral presentation at the European Society of Cardiology Heart Failure 2018 World Congress.
RDI Initiates Coverage on:
vTv Therapeutics Inc.
ARCA biopharma, Inc.
vTv Therapeutics Inc. shares closed up almost 19% yesterday on almost 10.5 million shares traded. The company said on Wednesday that it has identified a subpopulation that showed statistically significant benefit (unadjusted for multiple, post hoc comparisons) from azeliragon relative to placebo on ADAS-cog. Azeliragon is the company's investigational medicine for people with mild Alzheimer's disease. The company based the identification on post-hoc analyses of the data from Part A of the Company's Phase 3 STEADFAST study of azeliragon. The drug did not meet co-primary endpoints, however, the identified subpopulation consisted of participants with peak azeliragon blood plasma concentration of less than 7.5 ng/mL. The company said in a press release that 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. CEO Steve Holcombe remarked, "We are encouraged by the positive improvements in cognitive and functional outcomes relative to placebo based upon low azeliragon concentration levels. With this understanding, we are continuing to analyze the data and then plan to examine the relevant population prospectively in the Part B study and announce results in June."
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ARCA biopharma, Inc. shares closed up 14.37% on Thursday with around 10 million shares traded. The biopharma company said yesterday that data from the Phase 2B GENETIC-AF clinical trial has been selected for a "Late Breaking Clinical Trials" oral presentation at the European Society of Cardiology Heart Failure 2018 World Congress. The world's leading congress for experts in cardiology will be held on May 26th until the 29th in Austria. GENETIC-AF was a Phase 2B multi-center, randomized, double-blind, clinical superiority trial comparing the safety and efficacy of Gencaro™ against an active comparator, the beta-blocker Toprol XL (metoprolol succinate) for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF). Topline results of the study were reported back in February.
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