Clywedog Therapeutics Inc, a US-based clinical-stage biotechnology company, announced on Wednesday the activation of all clinical centres and patient dosing in its international Phase 1b randomised, double-blind, placebo-controlled clinical study evaluating balomenib, a novel oral menin inhibitor, in adults with type 2 diabetes mellitus (T2DM).

A formal regulatory authorisation was granted to the study in September. It is expected to enrol up to 60 participants.

In the completed Phase 1 single- and multiple-ascending dose studies, Balomenib demonstrated dose-dependent pharmacokinetics and pharmacodynamics, along with favourable safety and tolerability. Dosing was evaluated up to 600 mg twice daily. Targeting menin-dependent biology offers a differentiated and potentially disease-modifying approach, and this study provides an important foundation for expanding the diabetes platform across type 2 and type 1 diabetes, the company said.

The Phase 1b study is designed to evaluate the safety and tolerability of orally administered balomenib over a 28-day treatment period, following a post-treatment observation phase of up to around three months. Participants are randomised 1:1 to receive either balomenib or placebo. In addition to safety endpoints, the study will explore balomenib's effects on a range of metabolic and glycaemic parameters relevant to T2DM, including fasting glucose regulation, insulin-glucose dynamics, pancreatic beta-cell function, glycated hemoglobin (HbA1c), and C-peptide levels.