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Investing.com -- Shares of vTv Therapeutics Inc . (NASDAQ:VTVT) rose 15% after the company announced that the FDA has lifted the clinical hold on its Cadisegliatin program for diabetes. Trading had been temporarily halted Monday morning but saw a significant uptick once it resumed.
The High Point, North Carolina-based biopharmaceutical company reported that the United States Food and Drug Administration (FDA) removed the clinical hold on its CATT1 Phase 3 trial in type 1 diabetes (T1D). The hold was initially placed due to an unresolved chromatographic signal in a study, which has now been identified as an experimental artifact.
vTv Therapeutics plans to resume the trial after a protocol amendment aimed at shortening the trial’s duration from 12 to 6 months. This change is expected to expedite the process towards initiating larger pivotal studies needed for a New Drug Application (NDA) submission. The primary endpoint of the trial, which is to ascertain level 2 and 3 hypoglycemia rates at 6 months, will remain unchanged.
Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics, expressed his satisfaction with the FDA’s decision and the company’s eagerness to restart the Phase 3 trial. He highlighted the potential of Cadisegliatin to become the first oral adjunct therapy for T1D and its ability to improve glycemic control and reduce the incidence of hypoglycemia over insulin alone.
The optimism surrounding the resumption of the trial is grounded in the drug’s potential and past tolerability, with over 500 subjects treated for up to six months. Cadisegliatin, also known as TTP399, is a liver-selective glucokinase activator that has shown promise in nonclinical studies by increasing hepatic glucose uptake and glycogen storage, independently of insulin.
While the safety and efficacy of Cadisegliatin are still under investigation and approval is not guaranteed, the lifting of the clinical hold has clearly resonated positively with investors, reflected in the stock’s rise.
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