Phase 1/2 RESTORE-MASH trial will evaluate safety, pharmacokinetics, and pharmacodynamics of TGM-312 in healthy volunteers and MASH patients
Initial data anticipated H2 2026
LONDON, March 05, 2026 (GLOBE NEWSWIRE) -- Tangram Therapeutics ('Tangram'), a company committed to uniting computation and RNAi to make better medicines faster, today announced the dosing of the first participant in its Phase 1/2 RESTORE-MASH trial evaluating TGM-312, a novel GalOmic medicine, in healthy volunteers and people living with metabolic dysfunction-associated steatohepatitis (MASH).
MASH is a serious liver disease that is estimated to affect more than 250 million people globally. The disease is characterized by fat accumulation in the liver which can progress to cirrhosis, liver failure, liver cancer, need for liver transplantation, and premature mortality if left untreated.
TGM-312 is designed to specifically silence a novel target gene in hepatocytes to treat MASH and is the first GalOmic medicine to enter clinical trials. The Phase 1/2 RESTORE-MASH trial aims to evaluate TGM-312 in healthy adult volunteers and people with MASH, assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of the candidate. The MASH cohorts will incorporate liver biopsies alongside exploratory imaging and biomarker assessments. Initial safety data are anticipated H2 2026.
"Initiating RESTORE-MASH dosing is a defining moment for Tangram and an important step towards bringing our GalOmic medicines to patients," said Ali Mortazavi, Chief Executive Officer. "Having generated outstanding preclinical data, we're excited to now evaluate TGM-312 in clinical trials. We believe TGM-312 could serve as a differentiated backbone therapy across MASH segments, both as monotherapy and in combination with approved and emerging treatments. TGM-312 has the potential to offer a patient-friendly treatment option to support liver health in a rapidly evolving landscape."
About TGM-312
TGM-312 is a novel GalOmic GalNAc-conjugated small interfering RNA (GalNAc-siRNA) designed to selectively silence a gene target in the liver for the treatment of steatotic liver diseases, including metabolic dysfunction-associated steatohepatitis (MASH), with potential for quarterly subcutaneous administration. TGM-312 has a differentiated mechanism of action that tackles multiple key drivers of MASH and is complementary to approved and emerging therapies, supporting potential use both as monotherapy and in combination across a broad range of disease stages.
In preclinical studies in the highly translational Gubra-Amylin NASH diet-induced obese (GAN-DIO) mouse model, administration of TGM-312 led to dramatic reductions in NAFLD Activity Score (NAS), decreased hepatic inflammation and slowed fibrosis progression, both as monotherapy and in combination with approved and emerging MASH therapies.
About Tangram Therapeutics
Tangram Therapeutics is a clinical-stage biotech company committed to uniting computation, RNAi, and unconventional thinking to make better medicines faster. We are advancing a pipeline of GalOmic RNAi medicines for a broad range of diseases with high unmet need.
Tangram's innovative medicines are enabled by GalOmic, our proprietary RNAi chemistry platform designed to selectively silence disease-driving genes in hepatocytes. Discovery is powered by LLibra OS, our next-generation AI platform with an agentic infrastructure. The unique combination of these platforms is the foundation of our Relentless Medicine Discovery. Faster, smarter development of RNAi medicines designed for real-world impact.
Learn more at www.tangramtx.com.
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