The Food and Drug Administration (FDA) has granted fast-track designation to Priothera’s mocravimod combined with allogeneic Hematopoietic Stem cell Transplant (HSCT) for post-remission therapy patients with Acute Myeloid Leukemia (AML) patients.
Mocravimod or KRP 203 is a novel synthetic, sphingosine 1-phosphate receptor modulator. Its safety profile, tolerability and efficacy have been evaluated for several autoimmune indications in phase 1 and II clinical studies.
The drug is designed to enhance the curative potential of HSCT for AML patients. The company plans a global MO-TRANS Phase IIb/III study on around 250 patients receiving allogeneic HSCT. The clinical trial will include patients from Europe, US, and Japan, and is expected to begin late this year. The preliminary findings from the study are expected by the end of 2024.
The head of Priothera’s regulatory affairs, Karen Von Graevenitz, said: “The Fast Track designation grant for mocravimod in combination with allogeneic HSCT is an important milestone and underlines the significant unmet need in AML patients undergoing HSCT, a serious disease where currently no available therapy exists. The designation means mocravimod will be eligible for expedited review. We will work closely with the US FDA to advance the global Phase II/III trial, which is due to start in the second half of 2022.”
In March early this year, the FDA and European medical agency (EMA) had assigned orphan status to mocravimod.