vTv Therapeutics Announces Restructuring to Prioritize its Lead Program and Focus Operations

Rhea-AI Summary

vTv Therapeutics Inc. (Nasdaq: VTVT) announced a 65% workforce reduction to prioritize its lead program, TTP399, for type 1 diabetes, as it prepares for Phase 3 pivotal trials. TTP399 demonstrated a ~40% reduction in hypoglycemic episodes compared to placebo in Phase 2 studies and has received Breakthrough Therapy Designation from the FDA. The company also suspended development on HPP737, a psoriasis treatment, while supporting partnered programs. vTv aims to focus on improving the quality of life for diabetes patients with TTP399.

Positive

• TTP399 shows ~40% reduction in hypoglycemic episodes compared to placebo.
• Received Breakthrough Therapy Designation from the FDA for TTP399.
• Strategically focusing on TTP399 enhances growth potential.

Negative

• Workforce reduction of 65% may indicate financial instability.
• Pausing HPP737 development raises concerns about portfolio diversity.

-Workforce reduction of 65%

-Prioritization of lead program TTP399, a potentially transformative treatment for the reduction of hypoglycemic episodes in type 1 diabetes patients

HIGH POINT, N.C., Dec. 06, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for diabetes, today announced the prioritization of its lead program TTP399 as it gears up for Phase 3 pivotal trials.

TTP399 is a novel, oral, liver-selective glucokinase activator that showed ~40% reduction in hypoglycemic episodes compared to placebo in its Phase 2 study and was granted Breakthrough Therapy Designation by the FDA. In October, the Company announced positive results of its mechanistic study showing no increased risk of ketoacidosis. Additionally, zero hypoglycemic episodes occurred in the TTP399 arm while four occurred on placebo.

Type 1 Diabetes (T1D) is an autoimmune disease with no cure affecting over 1.6 million people today in the United States. Hypoglycemia is the most common acute complication in T1D. Adult-onset T1D has become more common than childhood-onset with more than half of all new cases diagnosed in adult patients. The patient population is expected to grow worldwide, with an estimated projection of 5 million patients in the U.S. by 2050.

Due to its shift in strategic focus, the Company:

• Reduced its workforce by approximately 65%;
• Added several consultants with track records of drug approvals with extensive Regulatory, Clinical, and Biostatistics experience;
• Paused vTv’s development activities on HPP737, a PDE4 inhibitor for treatment of psoriasis, while it evaluates strategic options; and
• Continues to support the development of its partnered programs.

“It is always difficult to restructure but this allows us to focus on TTP399 and our future growth,” said Deepa Prasad, President and Chief Executive Officer of vTv Therapeutics. “Hypoglycemia management is a serious issue impacting the lives of patients and their families. We are very excited to see TTP399’s novel mechanism of action allowing for reduction of hypoglycemic episodes with a well-tolerated safety profile. We continue to engage with the FDA to map out a clear and positive path forward on our Phase 3 pivotal studies with the goal of improving quality of life for patients managing this chronic, burdensome disease.”

About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company committed to improving the lives of diabetes patients by developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by its program for the treatment of type 1 diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer.

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:
IR@vtvtherapeutics.com 

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Media:
PR@vtvtherapeutics.com 

FAQ

What is TTP399 and why is it significant for vTv Therapeutics (VTVT)?

TTP399 is a liver-selective glucokinase activator that reduces hypoglycemic episodes in type 1 diabetes patients, significant for vTv's focus on improving diabetes management.

What does the 65% workforce reduction mean for vTv Therapeutics (VTVT)?

The workforce reduction suggests a strategic pivot and potential financial strain as the company prioritizes TTP399.

What are the latest developments for vTv Therapeutics' TTP399?

vTv is preparing for Phase 3 pivotal trials for TTP399, following positive Phase 2 results and FDA Breakthrough Therapy Designation.

What risks does vTv Therapeutics (VTVT) face after workforce reductions?

Risks include reduced operational capacity and potential challenges in managing ongoing projects effectively.

How does the FDA's Breakthrough Therapy Designation affect TTP399?

It expedites the development process and emphasizes the drug's potential to address unmet medical needs in diabetes management.