vTv Therapeutics Inc (NASDAQ: VTVT) is climbing early on in the trading session this morning after announcing that it has received Breakthrough Therapy designation from the FDA for its TTP399 candidate. Here’s what’s going on:
vTv Therapeutics Climbs On Breakthrough Therapy Designation
In an early morning press release, vTv Therapeutics said that it has received Breakthrough Therapy designation for TTP399 from the United States Food and Drug Administration, or FDA. The designation surrounds the therapy as an adjunctive therapy to insulin for the treatment of type 1 diabetes.
TTP399 is a novel, oral, investigational once-daily glucokinase activator.
In the release, vTv Therapeutics went on to say that the Breakthrough Therapy designation was provided based on the FDA’s determination that preliminary clinical evidence indicates that an investigational therapy may demonstrate substantial improvement on one or more significant endpoints relative to available therapies for serious or life-threatening conditions.
Why Breakthrough Therapy Designation Is So Exciting
Breakthrough designation comes with several benefits to vTv Therapeutics. Some of the most significant of these benefits include:
- Sponsor & Added Support. As a result of the designation, the company will receive a sponsor with added regulatory support, which will assist in the fast-paced development of the therapeutic.
- Review Timelines. Once the New Drug Application is submitted, the company will qualify for expedited review timelines.
Beyond the benefits, Breakthrough Therapy designation is great news as it validates the company’s work. After all, the FDA isn’t just handing out these designations. In fact, the designation for TTP399 in type 1 diabetes was supported by positive results from a Phase 2 clinical study.
In the Phase 2 study, treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo as well as a clinically meaningful decrease in the frequency of severe and symptomatic hypoglycemia. At the same time, the treatment resulted in a favorable safety and tolerability profile.
In a statement, Steve Holcombe, CEO at vTv Therapeutics, had the following to offer:
This FDA Breakthrough Therapy designation is an important milestone in the development of TTP399 for the treatment of type 1 diabetes, a serious, life threatening, and life-long condition impacting the day-to-day lives of more than a million Americans.
Hypoglycemia remains a leading cause of morbidity and potential mortality in the treatment of type 1 diabetes. Patient and prescriber fear of hypoglycemia often precludes tight glycemic control and this FDA designation highlights the potential of TTP399 to address this serious unmet medical need. We look forward to working with the FDA as we advance the development of TTP399, and in particular as we begin pivotal trials later this year.
The Bottom Line
The bottom line here is simple. The news released by vTv Therapeutics proved to be overwhelmingly positive. Diabetes is a serious, life-threatening condition, and while there are treatments out there, vTv is taking a new approach to the treatment of the condition, which seems to be overwhelmingly safe and effective to date.
With this designation, the company will enjoy increased support from the FDA and likely a fast-paced timeline to potential regulatory approval. All in all, there are plenty of reasons to be excited about VTVT stock.