Tangram Therapeutics has submitted a clinical trial application (CTA) to the Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase I/II trial of TGM-312.
TGM-312 is an investigational GalOmic small interfering RNA (siRNA) that aims to silence a gene in hepatocytes as a treatment fir metabolic dysfunction-associated steatohepatitis (MASH).
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The proposed Phase I/II study will assess TGM-312 in healthy adult individuals and MASH patients, focusing on the pharmacodynamics, tolerability, safety, and pharmacokinetics.
Liver biopsies and exploratory imaging and biomarker endpoints will also be part of the MASH patient evaluations.
Subject to regulatory clearance, the trial is set to begin in early 2026 in the UK, with initial data expected in the second half of 2026.
Preclinical studies in the Gubra-Amylin NASH diet-induced obese mouse model demonstrated reductions in slowed fibrosis progression, NAFLD Activity Score, and decreased hepatic inflammation, both as a single agent and along with emerging and approved MASH therapies.
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By GlobalDataTangram Therapeutics CEO Ali Mortazavi said: “The submission of our first CTA is a significant milestone for Tangram. It is a testament to the power of combining AI and RNAi to discover novel medicines and the passion of our lean team.
“TGM-312 has the potential to offer a differentiated and patient-friendly therapeutic option for people living with MASH, where substantial unmet need remains.”
Tangram Therapeutics is advancing a pipeline of GalOmic RNAi medicines targeting a wide range of diseases with high unmet needs. The company’s medicines are enabled by its RNAi chemistry platform, GalOmic, designed to silence disease-driving genes in hepatocytes, selectively.
