We are a clinical-stage biopharmaceutical company

developing novel fatty acid synthase (FASN) inhibitors that are designed to treat dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. We are also exploring the use of our FASN inhibitors, which include our lead product candidate denifanstat and our pipeline product candidate, TVB-3567, in acne and in select forms of cancer, disease areas in which dysregulation of fatty acid metabolism also plays a key role.

Denifanstat in MASH

Our lead product candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). FASCINATE-1, our Phase 2 clinical trial in patients with MASH, showed that denifanstat was well-tolerated with a favorable pharmacokinetic profile. We announced the successful completion of FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, in January 2024.

Development Pipeline: Indications and Clinical Milestones

Stage of Development

Therapeutic area

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Denifanstat Ph2b study complete

Metabolic
disease

Denifanstat Ph1 hepatic impairment study complete
TVB-3567

Dermatology

Denifanstat (ASC40)
TVB-3567

Oncology

Denifanstat
Denifanstat (ASC40)

* Trials conducted in China by Ascletis, who has licensed development and commercialization rights to all indications in Greater China

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Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH