TGM-312 / Tangram Therapeutics - LARVOL DELTA

Study of TGM-312-SC01 in Healthy Participants and Adults With MASH (clinicaltrials.gov) - P1/2 | N=99 | Recruiting | Sponsor: Tangram Therapeutics Plc | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Tangram Therapeutics Announces First Participant Dosed in Phase 1/2 RESTORE-MASH Trial of TGM-312, a Novel Investigational RNAi Medicine (GlobeNewswire) - "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."

P1/2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis

Study of TGM-312-SC01 in Healthy Participants and Adults With MASH (clinicaltrials.gov) - P1/2 | N=99 | Not yet recruiting | Sponsor: Tangram Therapeutics Plc

New P1/2 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Tangram Therapeutics…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. (The Manila Times) - "Pending regulatory clearance, the study is expected to commence in early 2026 in the United Kingdom, with initial data anticipated in H2 2026."

New P1/2 trial • P1/2 data • Metabolic Dysfunction-Associated Steatohepatitis

e-therapeutics Presents New Data Supporting ETX‑312 as a Differentiated and Disease-Modifying Near-Clinic Treatment for MASH (GlobeNewswire) - "In the leading Gubra‑Amylin NASH diet‑induced obese (GAN‑DIO) mouse model, ETX‑312 demonstrated: Dramatic improvements in NAFLD Activity Score (NAS) when administered as monotherapy or in combination with a GLP‑1/GIP receptor agonist or an FGF‑21 analogue. All mice receiving combination therapy achieved ≥ 2‑point reductions in NAS, with improvements of up to 5 points observed; Slowed fibrosis progression comparable to that achieved with GLP‑1/GIP receptor agonist or FGF‑21 analogue controls, supported by statistically significant reductions in hepatic collagen staining and in circulating biomarkers TIMP‑1 and PIIINP....ETX‑312 is currently in IND‑enabling studies, and the Company remains on track to submit a regulatory submission by the end of 2025."

IND • Preclinical • Metabolic Dysfunction-Associated Steatohepatitis