8-K: vTv Therapeutics' Cadisegliatin Program Receives FDA Green Light, Phase 3 Trial to Resume

The FDA has lifted the clinical hold on vTv Therapeutics' cadisegliatin program for diabetes, paving the way for the resumption of the CATT1 Phase 3 trial.

Summary

• vTv Therapeutics announced that the FDA has lifted the clinical hold on its cadisegliatin program for type 1 diabetes.
• The clinical hold was initially placed on July 26, 2024, due to an unresolved chromatographic signal in an ADME study.
• The company submitted a complete response letter, concluding the signal was an experimental artifact, leading to the hold being lifted on March 14, 2025.
• vTv Therapeutics plans to resume the CATT1 Phase 3 trial after submitting a protocol amendment to reduce the trial duration from 12 to 6 months.
• The primary endpoint of assessing hypoglycemia rates at 6 months remains unchanged.
• Cadisegliatin is a potential first-in-class oral adjunctive therapy to insulin for type 1 diabetes and has been generally well tolerated in over 500 subjects to date with up to six months of treatment.

Sentiment

Score: 8

Explanation: The sentiment is positive due to the FDA lifting the clinical hold, allowing the company to resume its Phase 3 trial and potentially bring a novel therapy to market. The planned reduction in trial duration is also a positive factor.

Positives

• The FDA lifting the clinical hold is a significant positive development for vTv Therapeutics.
• Shortening the CATT1 trial duration from 12 to 6 months will expedite the availability of topline data.
• Cadisegliatin has shown promise as a potential first-in-class oral adjunctive therapy for type 1 diabetes.
• The drug has been generally well tolerated in over 500 subjects.

Risks

• The success of the CATT1 Phase 3 trial is not guaranteed.
• Regulatory approval for cadisegliatin is not assured.
• The company's forward-looking statements are subject to risks and uncertainties, as detailed in their SEC filings.

Future Outlook

vTv Therapeutics expects to resume the CATT1 Phase 3 trial after submitting a protocol amendment to reduce the trial duration. The company aims to initiate larger Phase 3 studies sooner to support a future NDA submission.

Management Comments

• 'We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial,' said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics.
• Mr. Sekhri also stated that the company plans to submit a protocol amendment to reduce the time to topline data by 6-months, which will allow them to initiate larger Phase 3 studies sooner to support their future NDA submission.
• Mr. Sekhri believes that Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D.

Industry Context

The development of an oral adjunctive therapy to insulin for type 1 diabetes could represent a significant advancement in diabetes treatment, potentially improving glycemic control and reducing hypoglycemia.

Comparison to Industry Standards

• Other companies developing therapies for type 1 diabetes include Novo Nordisk, Eli Lilly, and Sanofi.
• These companies primarily focus on insulin therapies and glucose monitoring systems.
• Cadisegliatin's novel mechanism of action as a liver-selective glucokinase activator differentiates it from existing treatments.

Stakeholder Impact

• Shareholders will likely react positively to the news of the clinical hold being lifted.
• Patients with type 1 diabetes may benefit from the potential development of a new oral adjunctive therapy.
• The company's employees are likely to be encouraged by the progress of the cadisegliatin program.

Next Steps

• vTv Therapeutics will submit a protocol amendment to the FDA to reduce the CATT1 trial duration.
• The company will resume the CATT1 Phase 3 trial.
• vTv Therapeutics plans to initiate larger Phase 3 studies to support a future NDA submission.

Key Dates