vTv Therapeutics Announces Cadisegliatin Program for Type 1 Diabetes Placed on Clinical Hold

Rhea-AI Summary

vTv Therapeutics Inc. (Nasdaq: VTVT) announced that the FDA has placed a clinical hold on its cadisegliatin program for type 1 diabetes, including the ongoing CATT1 Phase 3 trial. The hold is due to an unresolved chromatographic signal discovered in a recent human ADME study. The FDA requires an in vitro study to characterize this signal before the program can resume.

Key points:

• No patients had been dosed in CATT1 at the time of the hold
• Past clinical studies showed no concerning safety issues
• Cadisegliatin has been well-tolerated in over 500 subjects for up to six months
• The company is working to resolve the hold and resume enrollment quickly

Positive

• Cadisegliatin has shown compelling efficacy and favorable safety profile in over 500 subjects
• The company is actively working with the FDA to resolve the clinical hold
• No concerning safety issues were revealed in past clinical studies

Negative

• FDA placed a clinical hold on the cadisegliatin program, including the CATT1 Phase 3 trial
• The clinical hold delays the development and potential approval of cadisegliatin for type 1 diabetes
• An unresolved chromatographic signal was discovered in a recent human ADME study

Pharmaceutical Industry Analyst

The FDA's clinical hold on vTv Therapeutics' cadisegliatin program is a significant setback for the company's type 1 diabetes treatment pipeline. This development raises several important points:

• Regulatory Hurdle: The FDA's decision, based on an unresolved chromatographic signal in a recent ADME study, underscores the rigorous safety standards in drug development. This unexpected issue highlights the complexities and uncertainties inherent in the pharmaceutical approval process.
• Timeline Impact: While vTv Therapeutics is working to resolve the issue with a single in vitro study, the clinical hold will inevitably delay the CATT1 Phase 3 trial. This could potentially push back the timeline for cadisegliatin's market entry, affecting the company's competitive position in the diabetes treatment landscape.
• Financial Implications: For a late-stage biopharmaceutical company like vTv, delays in its lead program can have significant financial repercussions. Investors should closely monitor the company's cash burn rate and funding situation during this period of clinical hold.
• Market Opportunity: Despite this setback, the potential market for an oral therapy in type 1 diabetes remains substantial. If cadisegliatin can overcome this hurdle and demonstrate efficacy and safety in Phase 3 trials, it could still capture a significant share of this unmet medical need.

Investors should remain cautious but attentive to updates from vTv Therapeutics regarding the resolution of this clinical hold and the subsequent progress of the cadisegliatin program.

Clinical Research Expert

The clinical hold on vTv Therapeutics' cadisegliatin program reveals some intriguing aspects of the drug development process:

• ADME Study Significance: The discovery of an unresolved chromatographic signal in the ADME study is a important finding. ADME studies are essential for understanding how a drug behaves in the body and any anomalies can raise red flags about potential safety issues or unexpected metabolic pathways.
• Safety Profile: It's noteworthy that cadisegliatin has been well-tolerated in over 500 subjects for up to six months of treatment without clinically concerning safety issues. This extensive safety data provides some reassurance, but the FDA's caution is warranted given the uncharacterized signal.
• Regulatory Diligence: The FDA's decision to require further characterization of the signal through an in vitro study demonstrates the agency's commitment to thorough safety evaluation, even for promising therapies addressing significant unmet needs.
• Study Design: The fact that no patients had been dosed in the CATT1 Phase 3 trial at the time of the clinical hold is fortunate, as it minimizes potential risks to study participants and simplifies the process of addressing the FDA's concerns.

The resolution of this clinical hold will depend on vTv's ability to quickly and satisfactorily characterize the chromatographic signal. The outcome of the required in vitro study will be important in determining the future of the cadisegliatin program.

HIGH POINT, N.C., July 26, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment.

The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. The Agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.

“Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal. We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Cadisegliatin demonstrated compelling efficacy and a favorable safety profile in over 500 subjects dosed to date, and we are highly encouraged at the potential of cadisegliatin to improve glycemic control and be a much-needed oral therapy for type 1 diabetes.”

About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator with first-in- class potential as an adjunct treatment for type 1 diabetes (T1D). Selectively acting on the liver, cadisegliatin increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage.

About vTv Therapeutics
vTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class adjunctive therapy to insulin for the treatment of type 1 diabetes.

Forward-Looking Statement
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.

Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com

FAQ

What caused the FDA to place a clinical hold on vTv Therapeutics' cadisegliatin program?

The FDA placed a clinical hold on vTv Therapeutics' cadisegliatin program due to an unresolved chromatographic signal discovered in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin.

How many subjects have been treated with cadisegliatin (VTVT) to date?

According to vTv Therapeutics, cadisegliatin has been well-tolerated in over 500 subjects to date, with treatment durations of up to six months.

What is required for vTv Therapeutics (VTVT) to resume the cadisegliatin clinical program?

The FDA requires vTv Therapeutics to conduct a single in vitro study to characterize the unresolved chromatographic signal before the cadisegliatin program can resume.

Were any patients dosed in the CATT1 Phase 3 trial before the clinical hold on VTVT's cadisegliatin?

No, vTv Therapeutics confirmed that no patients had been dosed in the CATT1 Phase 3 trial at the time of the clinical hold on cadisegliatin.