The Company expects to initiate first-in-human study in early 2026, with initial data anticipated H2 2026
Tangram Therapeutics, a company committed to uniting computation and RNAi to make better medicines faster, announced the submission of a Clinical Trial Application (CTA) to the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1/2 clinical trial of its lead pipeline program TGM-312. TGM-312 is an investigational GalOmic siRNA designed to specifically silence a novel gene in hepatocytes to treat metabolic dysfunction-associated steatohepatitis (MASH).
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“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,” commented CEO Ali Mortazavi. “TGM-312 has the potential to offer a differentiated and patient-friendly therapeutic option for people living with MASH, where substantial unmet need remains. With this submission, we are proud to advance our first GalOmic medicine into the clinic and become a clinical-stage company.”
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The proposed Phase 1/2 study will evaluate TGM-312 in healthy adult volunteers and patients with MASH, assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of the candidate. The trial will also include liver biopsies and exploratory imaging and biomarker endpoints in MASH patients. Pending regulatory clearance, the study is expected to commence in early 2026 in the United Kingdom, with initial data anticipated in H2 2026.
About TGM-312
TGM-312 is a novel GalOmic GalNAc-conjugated small interfering RNA (GalNAc-siRNA) therapeutic candidate in development as a safe and effective treatment for metabolic dysfunction-associated steatohepatitis (MASH). TGM-312 has potential for a patient-friendly quarterly subcutaneous dosing regimen. 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.
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Source- GlobeNewswire
