The U.S. Food and Drug Administration has granted Fast Track Designation to mocravimod in combination with allogeneic hematopoietic stem cell transplant for post-remission therapy in patients with acute myeloid leukemia (AML).
Mocravimod is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. S1PR modulators are known to largely reduce egress of T cells from lymphatic tissues. Not being an immunosuppressant, mocravimod maintains the graft-versus-leukemia benefits in patients receiving transplant while inhibiting graft-versus-host disease.
The drug has been assessed in phase I and II trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Mocravimod will be investigated as an adjunctive and maintenance treatment in a phase IIb/III study as a potential treatment for patients with AML receiving transplant.
Source: Priothera Press Release, June 2022