Active Biotech has secured approval from the European Medicines Agency (EMA) and institutional ethics committees to proceed with its Phase I/II clinical trial evaluating tasquinimod in patients with myelofibrosis who are either refractory to or intolerant of JAK2 inhibitor therapy. This regulatory clearance paves the way for the company to initiate patient enrollment in the near future.
The open-label, multicenter study is designed to evaluate the safety and efficacy of tasquinimod when administered as a monotherapy. The patient population will consist of individuals diagnosed with myelofibrosis who have previously undergone treatment with a JAK2 inhibitor or are deemed unsuitable candidates for such treatment. The primary endpoint is to assess the safety and tolerability of tasquinimod in this patient population.
Rationale for Tasquinimod in Myelofibrosis
According to CMO Erik Vahtola, the trial is underpinned by compelling preclinical evidence suggesting tasquinimod possesses disease-modifying capabilities. The study aims to address a critical unmet need in myelofibrosis patients who do not respond to or cannot tolerate JAK2 inhibitors, which are currently a standard treatment option.
Myelofibrosis is a rare and serious bone marrow disorder that disrupts the body's normal production of blood cells. It is characterized by bone marrow scarring, leading to anemia, fatigue, and an enlarged spleen. Patients who are resistant or intolerant to JAK2 inhibitors have limited treatment options, highlighting the importance of developing alternative therapies like tasquinimod.
