Clywedog Therapeutics' Phase Ib trial (n=60) found that a short 28‑day course of oral balomenib produced sustained reductions in HbA1c and fasting plasma glucose that persisted through 12–16 weeks of follow‑up. The placebo‑adjusted HbA1c decline was 0.77% at week 12 and 0.70% at week 16, with fasting glucose down 1.29 mmol/L at week 12. No unexpected safety issues were observed. A Phase IIa study evaluating a 12‑week regimen is planned for Q4 2026.
Balomenib Shows Durable Glycaemic Improvements After Short 28‑Day Course in Phase Ib Trial
No unexpected drug-related adverse events
Clywedog Therapeutics reported final results from a Phase Ib, randomized, double‑blind, placebo‑controlled study of oral balomenib in adults with type 2 diabetes (T2D). The trial tested a short 28‑day dosing regimen (including a one‑week pre‑dosing titration) followed by a 12‑week off‑treatment observation period and enrolled 60 participants across three countries. The last patient visit occurred on 11 July 2026.
Design And Endpoints
The primary endpoint was tolerability and safety at week 4; glycaemic outcomes were exploratory. Participants were randomized 1:1 to balomenib or placebo and were permitted up to three background oral antidiabetic agents (insulin was excluded). Mean baseline HbA1c was 8.84% in the balomenib arm and 8.52% in the placebo arm.
Key Efficacy Findings
Results indicate that glycaemic improvements were sustained after dosing stopped:
- At week 12 (approximately three months after the final dose) the placebo‑adjusted mean reduction in HbA1c was 0.77%.
- At week 16 the placebo‑adjusted HbA1c reduction was 0.70%, showing durability of effect.
- Placebo‑adjusted fasting plasma glucose fell by 1.29 mmol/L (≈23 mg/dL) at week 12.
- An oral glucose tolerance test on day 85 (eight weeks after the final dose) showed placebo‑adjusted reductions of 203 mmol·min/L in total glucose AUC, 2.03 mmol/L in peak glucose and 2.46 mmol/L in two‑hour glucose — corresponding to relative differences versus placebo of 11%, 11% and 15%, respectively.
Safety And Trial Conduct
No unexpected drug‑related adverse events, no treatment‑related discontinuations and no serious adverse events were reported. Through week 16, between 28 and 30 participants per arm were evaluable at each scheduled assessment, supporting the robustness of the follow‑up data.
Iain Dukes, CEO, Clywedog Therapeutics: "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."
Next Steps
Clywedog plans a Phase IIa randomized, double‑blind, placebo‑controlled study beginning in Q4 2026 to evaluate a longer, 12‑week treatment course followed by an off‑treatment follow‑up period.
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