Clywedog Therapeutics Announces Activation of All Centers and Patient Dosing in Multicenter, International Phase 1b Clinical Study of Balomenib in Type 2 Diabetes

DOVER, Del., Dec. 17, 2025 /PRNewswire/ — Clywedog Therapeutics, Inc., a clinical-stage biotechnology company advancing novel therapies for metabolic diseases, today announced the activation of all clinical centers and patient dosing in its multicenter, international Phase 1b randomized, double-blind, placebo-controlled clinical study evaluating balomenib, a novel oral menin inhibitor, in adults with type 2 diabetes mellitus (T2DM).

The study received formal regulatory authorization in September and is expected to enroll up to 60 participants.

“This milestone marks the full operational launch of the Phase 1b program and represents a critical step in advancing balomenib into patient studies in metabolic disease,” said Iain Dukes, Chief Executive Officer of Clywedog Therapeutics. “With all centers activated and patient dosing underway, the company is positioned to efficiently generate clinical data that will inform both the safety profile of balomenib and its potential impact on metabolic parameters central to type 2 diabetes.”

Balomenib demonstrated dose-dependent pharmacokinetics and pharmacodynamics, along with favorable safety and tolerability, in the completed Phase 1 single- and multiple-ascending dose studies, with dosing evaluated up to 600 mg twice daily, the highest dose tested. 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.

About the Phase 1b Clinical Study

The Phase 1b study is designed to evaluate the safety and tolerability of orally administered balomenib over a 28-day treatment period, followed by a post-treatment observation phase of up to approximately three months. Participants are randomized 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 glycemic parameters relevant to T2DM, including:

• Fasting glucose regulation
• Insulin-glucose dynamics
• Pancreatic beta-cell function
• Glycated hemoglobin (HbA1c)
• C-peptide levels

The total duration of participation from first dose to final follow-up is approximately 16 weeks.

Advancing a Broad Platform for Diabetes and Immune-Mediated Diseases

Balomenib is a novel, orally administered menin inhibitor designed to disrupt pathological MEN1 protein-protein interactions implicated in the regulation of pancreatic beta-cell function, and survival. In addition to its potential utility in type 2 diabetes, MEN1 protein-protein interaction modulation represents a promising therapeutic strategy in type 1 diabetes, where preservation and restoration of residual beta-cell function remain critical unmet needs.

Clywedog is also advancing selective TYK2 inhibitor programs targeting immune-mediated pathways implicated in the pathogenesis and potential prevention of type 1 diabetes, including modulation of interferon and cytokine signaling involved in autoimmune beta-cell destruction. MEN1-based metabolic modulation and TYK2-mediated immune regulation may be complementary, supporting the exploration of combination approaches aimed at addressing both beta-cell dysfunction and autoimmune drivers of disease.

About Clywedog Therapeutics, Inc.

Clywedog Therapeutics is a clinical-stage biotechnology company focused on the discovery and development of innovative small-molecule therapies for metabolic, endocrine, and immune-mediated diseases. The company’s pipeline integrates targeted protein-protein interaction modulation, immune signaling control, and combination-ready platform technologies with the goal of delivering durable, disease-modifying clinical benefit.

Contact:

Iain Dukes, M.A. D.Phil.

Chief Executive Officer

Email: DukesI@orbimed.com

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SOURCE Clywedog Therapeutics, Inc.