vTv Therapeutics plans to initiate a Phase III clinical trial for cadisegliatin for treating type 1 diabetes (T1D) by the end of 2023 before filing for marketing approval with the US Food and Drug Administration (FDA).

Cadisegliatin is a liver-selective glucokinase activator that is used as an adjunct therapy with insulin. It received a breakthrough therapy designation (BTD) based on its Phase II trial (NCT03335371), which showed a 40% decrease in the frequency of severe and symptomatic hypoglycaemic events along with a decrease in serum and urine ketone events in the treatment group.

The Phase III trial will assess the reduction in the number of hypoglycaemic events with cadisegliatin, compared to placebo. This primary endpoint for the trial is recommended by the FDA as part of the approval data for T1D drugs.

vTv plans to expand the drug indications for cadisegliatin to potentially include type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, glioblastoma and other cancer, and related conditions.

Hypoglycaemia is a significant concern for patients with T1D, as insulin treatment causes hypoglycaemia in these patients. Other drugs currently in development for treating insulin-induced hypoglycaemia include Zucara Therapeutics’ ZT-01.

vTv’s other drug azeliragon is currently in Phase II/III of development for triple-negative breast cancer by its partner, Cantex Pharmaceuticals. Azeliragon is a receptor for advanced glycation end products (RAGE) inhibitor which is being investigated for multiple indications including Alzheimer’s disease, Covid-19 complications, brain metastasis, glioblastoma, inflammatory lung disease, and other cancer indications.

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The company’s cash reserves stand at $12.6m as of 30 June 2023. vTv now has until 18 December 2023 to comply with Nasdaq’s Minimum Bid Requirement, which requires a company’s ordinary shares to have a value of at least $1 for a minimum of ten business days. The value of vTv’s share stands at $0.72, as of the market close on 11 August, with a market cap of $58.75m.