We are a clinical-stage biopharmaceutical company
developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. We are exploring the use of our FASN inhibitors, including our clinical-stage product candidates denifanstat and TVB-3567, in metabolic dysfunction associated steatohepatitis (MASH), acne and select forms of cancer, disease areas in which dysregulation of fatty acid metabolism 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). FASCINATE-1, a Phase 2 clinical trial in patients with MASH, showed that denifanstat was well-tolerated with a favorable pharmacokinetic profile. Denifanstat also met all primary and multiple secondary endpoints in FASCINATE-2, a Phase 2b clinical trial of denifanstat in biopsy-confirmed MASH patients. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
We are developing a combination of denifanstat, and the thyroid hormone receptor beta (THR-β) agonist, resmetirom (commercially available as Rezdiffra), for cirrhotic patients living with F4-stage cirrhotic MASH.
Development Pipeline: Indications and Clinical Milestones
Stage of Development
Therapeutic area
Indication
Preclinical
Phase 1
Phase 2
Phase 3
Metabolic
disease
* Trial conducted in China by Ascletis, who has licensed development and commercialization rights to all indications in Greater China
