vTv Therapeutics Reports Positive Midstage Trial Results For Type 1 Diabetes Drug

Shares of vTv Therapeutics Inc VTVT shares showed strength in pre-market trading Thursday and were trading down after the open following a clinical trial readout from the company.

What Happened

The micro-cap biotech announced top-line results from part 1 of a Phase 2 trial, Simplici-T1, which evaluated its TTP399 in adults with Type 1 diabetes. The pipeline asset achieved a statistically significant mean reduction in HbA1c, aka glycated hemoglobin – hemoglobin covalently bound to glucose, at 12 weeks, the company said. 

TTP399 is a liver-selective glucokinase activator.

The Simplici-T1 trial is a double-blinded, placebo-controlled 12-week trial, with the baseline mean HbA1c at 7.3 percent for the TTP399 treated arm and 7.4 percent for the control arm.

Patients treated with TTP399 showed a mean reduction of 0.6 percent in Hb1Ac at 12 weeks compared to a mean increase of 0.1 percent for the group treated with placebo.

The company said trends toward decreased insulin usage were observed in the TTP399 arm.

The pipeline asset was also found to be well-tolerated, with similar incidences of treatment-emergent adverse events overall and by system organ class, with no serious adverse events reported.

Why It's Important

Insulin remains the main line of treatment for Type 1 diabetes, and adjuvant treatments to insulin will lead to improvements in metabolic balance and favorable treatment outcomes.

If the results hold up in the second part of the trial, TTP399 will stand as the most impressive adjunctive therapy to insulin in Type 1 diabetes, vTv said. 

What Next

vTv said it expects to present more detailed study results at the 55th Annual Meeting of the European Association for the Study of Diabetes in Barcelona, Spain in September.

The results from the Part 2 study in a broader patient population are expected in the first quarter of 2020.

Shares of vTv were down 0.6 percent at $1.66 at the time of publication Thursday. 

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