Clywedog Therapeutics has reported final results from a Phase Ib trial of its investigational oral drug balomenib in adults with type 2 diabetes (T2D), with reductions in haemoglobin A1c (HbA1c) and fasting plasma glucose maintained after treatment ended.
The placebo-controlled, double-blind, randomised trial enrolled 60 adults across three countries.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Participants received balomenib or placebo in a 1:1 allocation for 28 days, including a one-week pre-dosing titration period, followed by a 12-week off-treatment observation period. The last patient visit took place on 11 July 2026.
At week 12, three months after the final dose, the placebo-adjusted mean reduction in HbA1c was 0.77%.
The reduction was 0.70% at week 16. The placebo-adjusted mean reduction in fasting plasma glucose at week 12 was 1.29mmol/L or 23mg/dL.
An oral glucose tolerance test at day 85, eight weeks after the final dose, showed placebo-adjusted reductions of 203mmol•min/L in total glucose area under the curve, 2.03mmol/L in peak glucose and 2.46mmol/L in two-hour glucose.
These differences from placebo were 11%, 11% and 15%. The company said the treatment groups were superimposable at baseline.
The trial’s primary endpoint was tolerability and safety at week 4, while glycaemic measures were exploratory endpoints.
Participants had mean baseline HbA1c levels of 8.84% in the balomenib group and 8.52% in the placebo group and were using up to three background antidiabetic agents excluding insulin.
There were no unexpected drug-related adverse events, serious adverse events or treatment-related discontinuations. Through week 16, 28 to 30 participants in each arm were evaluable at every scheduled assessment.
Clywedog Therapeutics CEO Iain Dukes said: “The central observation is that after only a three-week course of treatment, balomenib produced sustained improvements in glycaemic control consistent with a disease-modifying mechanism of action.
“Inhibition of menin signalling resulted in pluralistic improvements in insulin sensitivity and insulin secretion, effects which should be expected to deepen following longer courses of treatment.”
Clywedog plans to begin a Phase IIa randomised, double-blind, placebo-controlled study in Q4 2026. The study is intended to evaluate a 12-week treatment course followed by an off-treatment follow-up period.
