vTv Therapeutics Announces FDA Submission for First Phase 3 Study of Cadisegliatin in Patients with Type 1 Diabetes

Rhea-AI Summary

vTv Therapeutics Inc. announces the submission of the study protocol to the FDA for its Phase 3 trial evaluating cadisegliatin as an adjunctive therapy to insulin for type 1 diabetes. The trial aims to enroll 150 patients across 20 sites in the US, with the primary endpoint being the comparison of hypoglycemic events between cadisegliatin-treated and placebo groups.

Medical Research Analyst

The initiation of a Phase 3 clinical trial is a pivotal moment in the lifecycle of a biopharmaceutical product, indicating that prior research has yielded sufficient evidence to suggest potential efficacy and safety worthy of larger-scale testing. The trial for cadisegliatin targets a significant market, as type 1 diabetes ('T1D') affects approximately 1.6 million Americans, according to the American Diabetes Association. The study's design, a randomized, double-blind, placebo-controlled trial, is the gold standard for determining drug efficacy, aiming to minimize bias and provide reliable data for regulatory review.

From a medical research perspective, the primary efficacy endpoint focusing on the reduction of Level 2 or Level 3 hypoglycemic events is particularly relevant. These events are serious complications of diabetes management and can lead to emergency interventions. A successful outcome could position cadisegliatin as a significant adjunctive therapy in T1D management, addressing an unmet medical need and potentially improving patient quality of life. The oral administration of the drug, if effective, would also be a notable convenience factor over injectable therapies, possibly improving treatment adherence.

Financial Analyst

The announcement of a Phase 3 trial commencement is a critical event for vTv Therapeutics and its investors. As a clinical-stage company, vTv's valuation is heavily dependent on the progression of its pipeline products. The market for diabetes treatments is robust, with a global value expected to reach billions of dollars. The investment by institutional investors, as mentioned by vTv's CMO, underscores the potential financial upside of cadisegliatin.

However, it is essential to note that biopharmaceutical investing is high-risk, given the uncertainty of clinical trial outcomes. Investors should consider the long development timelines and the capital required to reach commercialization. The collaboration with G42 Healthcare Research Technology Projects LLC and IROS may mitigate some financial risks through cost-sharing and could provide strategic advantages in diversifying the geographical scope of the trials and potential markets. Should cadisegliatin prove successful, it could lead to significant revenue streams for vTv Therapeutics, but the opposite holds true if the trial results are unfavorable.

Market Research Analyst

The landscape for diabetes treatment is highly competitive, with numerous established players and a continuous influx of innovative therapies. The differentiation of cadisegliatin as an oral adjunctive therapy could carve out a niche in the treatment regimen for T1D, which is currently dominated by injectable insulins and continuous subcutaneous insulin infusion therapies. A market research analysis would focus on the drug's potential adoption rate, considering factors such as ease of use, efficacy, safety profile and cost.

Moreover, the use of continuous glucose monitors (CGMs) in the trial reflects current trends in diabetes management, where technology plays an increasingly vital role. The integration of cadisegliatin within this technological ecosystem could be a critical factor in its uptake. Additionally, the expansion of research into type 2 diabetes ('T2D') suggests that vTv Therapeutics is not only targeting the T1D market but is also positioning itself for entry into the larger T2D market, which could exponentially increase the drug's commercial potential.

HIGH POINT, N.C., March 04, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today announced the submission of the study protocol to the FDA for the Company’s first Phase 3 trial evaluating the safety and efficacy of its lead candidate, cadisegliatin, in adults diagnosed with T1D.

This randomized, double-blind, placebo-controlled trial is expected to enroll approximately 150 patients at up to 20 sites in the United States, with the first patient expected to be enrolled in the second quarter of 2024.

The Phase 3 study will assess two doses of orally administered cadisegliatin versus placebo in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion, who use a continuous glucose monitor (CGM). The primary efficacy endpoint of the study will compare the incidence of Level 2 or Level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group.

This trial further expands vTv’s research into cadisegliatin as an adjunctive therapy to insulin, which also includes a planned Phase 2 trial in patients with type 2 diabetes expected to start in Middle Eastern countries in 2024 in collaboration with vTv’s partner G42 Healthcare Research Technology Projects LLC and its clinical research organization IROS, a UAE-based health technology group.

“vTv’s primary focus is on expeditiously confirming the safety and efficacy of cadisegliatin, and this initial Phase 3 trial will help provide a more robust body of clinical evidence on the drug’s profile in a relatively short timeframe. The ongoing support from institutional investors who participated in our recent private placement reflects the urgent need for treatments that improve glycemic control and have a positive impact on the quality of life of patients with T1D,” said Thomas Strack, MD, PhD, Chief Medical Officer, vTv Therapeutics.

Cadisegliatin is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.

About Cadisegliatin

Cadisegliatin (TTP399) is an investigational liver-selective glucokinase activator that has been studied in healthy volunteers and in patients with type 1 and type 2 diabetes.

About vTv Therapeutics

vTv Therapeutics Inc is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin (TTP399), a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications including type 2 diabetes and other chronic conditions.

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. In addition, we may not be able to successfully complete a successful financing, partnering or licensing transactions with respect to cadisegliatin. 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:

Lee Roth

Burns McClellan

lroth@burnsmc.com

Media:

Selina Husain / Robert Flamm, Ph.D.

Burns McClellan, Inc.

shusain@burnsmc.com / rflamm@burnsmc.com 

What is vTv Therapeutics Inc.'s ticker symbol?

The ticker symbol for vTv Therapeutics Inc. is VTVT.

What is the focus of vTv Therapeutics Inc.?

vTv Therapeutics Inc. is focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes.

What is the primary efficacy endpoint of vTv Therapeutics Inc.'s Phase 3 trial?

The primary efficacy endpoint of the Phase 3 trial is to compare the incidence of Level 2 or Level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group.

Is cadisegliatin approved for use globally?

Cadisegliatin is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.