Solution Spotlight: Avatrombopag

Dova continues to develop avatrombopag, an investigational second generation oral thrombopoietin receptor agonist that stimulates platelet production. The drug, which has not been approved by the U.S. Food & Drug Administration or other regulatory authorities, has completed two Phase 3 randomized, double-blind, placebo-controlled, clinical studies investigating its use as a potential treatment for thrombocytopenia in patients with chronic liver disease (CLD) undergoing a planned medical procedure.

Thrombocytopenia in CLD Patients

There are approximately 7.4MM patients in the United States with CLD. Given the nature of the disease, a common complication in this patient population is thrombocytopenia, a disorder characterized by platelet counts <150,000 per microliter of circulating blood, which affects approximately 1.1MM of these patients. Approximately 70,000 of these patients have what is known as severe thrombocytopenia, which occurs when platelet counts fall below 50,000 per microliter of circulating blood.

When these patients undergo a routine planned medical procedure such as a liver biopsy, colonoscopy, dental procedure, etc., which typically occurs 1-3 times a year, medical treatment guidelines recommend a platelet transfusion prior to the procedure in order to prevent the risk of bleeding during or after the procedure. These platelet transfusions are associated with both limitations and risks including antibody development risk, infection risk, and patient inconvenience.

There are currently no drug treatments approved by the U.S. Food & Drug Administration or the European Medicines Agency in this setting for this patient population.

Avatrombopag

Avatrombopag, which has not been approved by the U.S. Food & Drug Administration or other regulatory authorities, is an orally administered, small molecule TPO RA, which is intended to address the limitations of platelet transfusions. We believe that our drug candidate, avatrombopag, has the potential to be a first-in-class treatment for patients with thrombocytopenia undergoing planned medical procedures.

Avatrombopag Status

To date, avatrombopag has been evaluated in more than 20 clinical trials involving more than 1,100 subjects and has been observed to be generally well tolerated. We recently completed two identically designed Phase 3 pivotal clinical trials, ADAPT 1 and ADAPT 2, in which all primary and secondary endpoints were met with high statistical significance.

 

  1. Medical procedure refers to a non-emergent, minimally to moderately invasive medical procedure
  2. Surgery includes spectrum of minimally invasive to highly invasive medical procedures. For highly invasive surgeries such as vascular, cardiac, brain or spine surgeries, many medical professional associations’ guidelines recommend that patients have at least 100K platelets / uL