Mocravimod Receives Orphan Drug Designation for AML in US and Europe

Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted orphan drug designation to mocravimod for the treatment of patients with acute myeloid leukemia (AML) undergoing allogeneic stem cell transplantation (SCT).

Mocravimod is a sphingosine 1 phosphate receptor modulator. Previously, the potential of mocravimod to enhance the effects of SCT has been tested in autoimmune indications.

In the second half of 2022, investigators plan to launch a global phase IIb study evaluating the safety and efficacy of mocravimod as an adjunctive and maintenance therapy to SCT in adult patients with AML.

Source: Priothera press release, March 3, 2022.