vTv Therapeutics Inc (NASDAQ: VTVT) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced news surrounding a Phase 3 clinical study in Alzheimer’s disease. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The clinical update;
- what we’re seeing from VTVT as a result;
- and what we’ll be watching for ahead.
VTVT Provides Clinical Update
As mentioned above, vTv Therapeutics is having an incredibly strong start to the trading session this morning after providing a clinical update. In a press release issued after-hours yesterday, the company announced that based on post-hoc analyses of the data from Part A of the company’s Phase 3 STEADFAST study, the company did not meet co-primary endpoints but has identified a subpopulation that showed statistically significant benefit from azeliragon relative to placebo.
In the release, VTVT said that the identified subpopulation consists of participants with peak azeliragon blood plasma concentrations of less than 7.5 ng/mL. As a result, the company said that based on this analysis, it will submit a revised Statistical Analysis Plan to the Food and Drug Administration for the Part B Study. The new plan will pre-specify a target population for the primary study analysis. The company said that it expects to report Part B topline efficacy results based on 12 month data in June of this year.
In the release, VTVT said that the patients identified in the subgroup showed a 1.9 point improvement in ADAS-cog relative to the placebo group. Also, the subgroup had a 0.5 point improvement on CDR-sb relatively to placebo, despite a smaller sample size. The company said that the benefits were observed over a period of 12 months and that the findings were consistent with results from an earlier Phase 2b study of azeliragon. In a statement, Steve Holcombe, CEO at VTVT, had the following to offer:
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.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In the case of vTv Therapeutics, the news proved to be overwhelmingly positive. After all, investors wondered what was going to happen with azeliragon after it was announced that the co-primary endpoints in the study were missed. However, with this new sub-population showing strong results, there’s a chance that the company could push for regulatory approval. So, it’s no surprise that excited investors are sending the stock toward the top. Currently (9:55), VTVT is trading at $2.21 per share after a gain of $0.50 per share or 29.47% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on VTVT. In particular, we’re interested in following the story surrounding the company’s work with regard to azeliragon. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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