FDA Clears Path for vTv Therapeutics' Cadisegliatin in Diabetes

FDA Lifts Clinical Hold on Cadisegliatin Program

Cadisegliatin has emerged as a promising oral adjunct therapy for those living with type 1 diabetes. This medication, under the development of vTv Therapeutics Inc., has recently seen a green light from the FDA, a significant milestone for the company.

Resumption of the CATT1 Phase 3 Trial

Following the FDA's decision, vTv Therapeutics plans to resume the CATT1 Phase 3 clinical trial of cadisegliatin. This trial aims to evaluate the efficacy of cadisegliatin, which is known to be an oral, liver-selective glucokinase activator. The company believes that by adjusting the protocol to shorten the study's total duration from 12 months to 6 months, they can gather essential data sooner.

Details of the Clinical Trial Amendment

The proposed amendment to the CATT1 trial will not affect the primary goal of evaluating hypoglycemia rates at the six-month mark. By condensing the trial’s timeframe, vTv Therapeutics intends to accelerate the process necessary for submission of a New Drug Application (NDA) in the future. This proactive approach is crucial to ensuring that the therapeutic benefits of cadisegliatin can reach patients in need more swiftly.

CEO’s Perspective on the FDA Decision

Paul Sekhri, Chairman and CEO of vTv Therapeutics, expressed his enthusiasm regarding the FDA’s decision to lift the clinical hold. He remarked, “We are delighted to move forward with our Phase 3 trial for cadisegliatin. This amendment is pivotal for us as it enhances our ability to obtain topline data promptly.” Sekhri emphasized the potential of cadisegliatin to serve as the first oral adjunctive therapy for type 1 diabetes, substantially benefiting the lives of individuals managing this chronic condition.

Background on Cadisegliatin

Cadisegliatin (TTP399) functions uniquely as a liver-selective glucokinase activator. Its mechanism allows it to optimize glucose metabolism in a way that is independent of insulin. By enhancing the liver's capacity to process and store glucose, cadisegliatin holds promise in improving glycemic control among type 1 diabetes patients, which could mitigate the risks associated with traditional insulin therapies.

Safety Profile and Clinical Data

With over 500 subjects participating in clinical trials thus far, cadisegliatin has been reported to be well-tolerated. The decision by the FDA to lift the clinical hold was backed by findings that indicated previous chromatographic signals observed were mere experimental artifacts. Notably, no patients had been dosed in the CATT1 trial during the hold period, reinforcing the safety precedence of the trials.

The Vision of vTv Therapeutics

vTv Therapeutics Inc. is committed to discovering and developing novel therapeutic options for chronic diseases. Alongside cadisegliatin, they have a rich pipeline of potential therapies aimed at enhancing patient outcomes. The company’s focus on innovative treatments is at the forefront of their operations, targeting areas where current options are limited.

Frequently Asked Questions

What is cadisegliatin?

Cadisegliatin is a novel oral medication being investigated as an adjunctive therapy for type 1 diabetes, functioning as a liver-selective glucokinase activator.

Why did the FDA lift the clinical hold?

The FDA lifted the hold after vTv Therapeutics clarified previous chromatographic signals were experimental artifacts and confirmed no safety issues were present.

What is the significance of the CATT1 trial?

The CATT1 Phase 3 trial aims to evaluate the efficacy of cadisegliatin in reducing hypoglycemia rates in type 1 diabetes patients.

How does cadisegliatin differ from traditional diabetes therapies?

Cadisegliatin acts independently of insulin to improve glycemic control, representing a new approach to managing type 1 diabetes.

What are the future plans for vTv Therapeutics?

vTv Therapeutics aims to complete the CATT1 trial and subsequently file for a New Drug Application to make cadisegliatin available to patients.

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