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NASH: Building a Platform Therapy for an Emerging Pandemic

NASH is emerging as the next major epidemic to threaten the health of people around the globe.  Diet and other factors lead to excess fat in the liver driving further lipid production, inflammation and fibrosis.  Left untreated, the damaged liver functions poorly, becoming cirrhotic and even cancerous with time.  The damage can also exacerbate a spectrum of other health problems including cardiovascular diseases.

3-V has used both cell-based and murine models demonstrating the potential to use a FASN inhibitor to treat NASH and restore liver health by reducing liver fat, inflammation and fibrosis.  3-V is currently conducting a Phase 1 study with experts at the University of Missouri to determine the dose of TVB-2640 that inhibits liver fat synthesis in humans. These data will enable a proof-of-concept Phase 2a study in patients with NASH.

 

Oncology: An Opportunity for Targeted Therapy

3-V continues to advance a novel program targeting the fatty acid synthase (FASN) enzyme for the treatment of cancer.  FASN over-expression is associated with aggressive disease in multiple tumor types (including breast, ovarian and KRas mutated non-small cell lung cancer) and provides an opportunity to identify patients most likely to respond to therapy. We designed our proprietary FASN inhibitors specifically to target FASN and minimize off-target effects.  In preclinical studies, our FASN inhibitors have demonstrated potent activity against a number of tumor types, potential synergy with approved cytotoxic agents, and excellent tolerability.  3-V has completed enrollment into a Phase 1 study with our lead FASN inhibitor in patients with solid tumors and early results have been reported at scientific conferences with the final clinical study report due in mid-2017.

 

TVB-2640: first-in-class, once daily, oral inhibitor of FASN

In a Phase 1 trial of TVB-2640 in patients with solid tumors we have established:

  • The safety profile supporting further development
  • Pharmacokinetic profile enabling once daily dosing
  • The maximally tolerated dose
  • FASN inhibition can be demonstrated in patients
  • Clinical activity observed in defined patient populations including breast, ovarian and non-small cell lung cancer with a KRas mutation

Additional details regarding our Phase 1 trial can be found on www.clinicaltrials.gov (NCT02223247) as well as on our Posters/Publications page.

An active clinical study is ongoing to determine the dose of TVB-2640 that inhibits liver fat synthesis in subjects with characteristics of metabolic syndrome (NCT02948569).