London, UK, September 3, 2026
Tangram Therapeutics announced that its investigational MASH treatment TGM-312 has progressed into Part B of the Phase 1/2 RESTORE-MASH clinical trial, marking the transition from healthy-volunteer testing to evaluation in patients with metabolic dysfunction-associated steatohepatitis (MASH). The progression follows a favorable review by the trial’s independent Data Monitoring Committee, supporting advancement from the initial single ascending dose stage to multiple ascending dose testing in MASH patients. TGM-312 is a liver-directed GalNAc-siRNA designed to selectively silence SLC25A5, a target identified through Tangram’s proprietary network biology approach combined with population genetic data from MASH and MASLD. The company said TGM-312 is designed to address key drivers of MASH, including inflammation and steatosis, while its liver-directed approach could support less frequent dosing and potentially reduce systemic exposure. Interim MASH patient data are expected during 2027, making the newly initiated patient cohorts an important upcoming clinical milestone for Tangram.
TGM-312 Advances Following Healthy-Volunteer Safety Data
Before entering the MASH patient cohorts, TGM-312 was evaluated across four healthy-volunteer cohorts in the ongoing RESTORE-MASH program. According to Tangram, the study has reported no serious or severe adverse events across those cohorts, providing an initial clinical safety foundation for progressing the investigational therapy into patient testing. The Phase 1/2 study is designed to evaluate the development candidate through escalating dose levels and provide information needed to support further clinical development. TGM-312 uses Tangram’s proprietary GalOmic RNAi chemistry, which is designed to selectively deliver the therapeutic to liver cells. The company believes the approach could enable an infrequently dosed treatment, with the potential for quarterly subcutaneous administration. Tangram is developing TGM-312 as both a potential monotherapy and combination treatment, based on its distinct mechanism compared with existing and emerging MASH therapies. The move into MASH patient cohorts therefore represents a key transition from early safety evaluation toward assessing the candidate’s potential therapeutic effects in the target disease population.
Tangram Appoints New Chief Development Officer
Alongside the clinical development update, Tangram Therapeutics appointed Dr Sonya Montgomery as Chief Development Officer, adding more than 25 years of drug development experience to the company’s leadership team. Dr Montgomery has worked across pharmaceutical and biotechnology organizations and has experience spanning translational research, clinical development, portfolio strategy and registration, including programs involving genetic medicines and multiple therapeutic modalities. Her previous leadership roles included positions at Pfizer, ProQR, Gyroscope Therapeutics, Evox Therapeutics and OSE Immunotherapeutics. Tangram said the appointment comes as the company advances TGM-312 further into clinical development and seeks to progress its broader pipeline. Dr Montgomery will be responsible for helping guide development strategy as TGM-312 moves through the clinic, while also supporting advancement of other programs, including TGM-148 for bleeding disorders. The leadership appointment adds experienced clinical-development expertise at an important stage of Tangram’s pipeline progression.
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RESTORE-MASH Sets Up 2027 Clinical Data Milestone
The progression of TGM-312 into MASH patient cohorts establishes the next phase of Tangram’s clinical development program, with the company now focused on generating patient data from RESTORE-MASH. TGM-312 is designed to target SLC25A5 in the liver, with Tangram positioning the program around a dual mechanism intended to influence both metabolic and inflammatory components of MASH. Preclinical studies previously showed reductions in disease activity, hepatic inflammation and fibrosis progression in a translational mouse model, including when TGM-312 was combined with other MASH approaches. However, those findings remain preclinical, and the key test for the program will be whether the mechanism translates into meaningful clinical benefits in patients. Tangram expects interim MASH patient data in 2027, which could provide the first important clinical assessment of TGM-312’s therapeutic potential. The company’s immediate focus is therefore on the execution of the RESTORE-MASH patient cohorts, while the appointment of Dr Montgomery is intended to strengthen development leadership as Tangram moves TGM-312 and its wider RNAi pipeline toward additional clinical milestones..
Source:Tangram Therapeutics,press relese
