The new investigational drug, also known as KRP203, is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator.
It has been evaluated in Phase I and Phase II trials for tolerability, efficacy, and safety in several autoimmune indications.
The drug will also be assessed as an adjunctive and maintenance treatment in the MO-TRANS global Phase IIb/III study of AML adult patients receiving allogeneic HSCT.
The company is working to begin the MO-TRANS study in Europe, US, and Japan. The trial is expected to commence in the second half of this year, with preliminary data anticipated by the end of 2024.
Priothera Regulatory Affairs head 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 and 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 this year, the US FDA and the European Medicines Agency (EMA) granted orphan drug designation (ODD) to mocravimod to treat AML in patients receiving HSCT.
ODD by EMA for the drug was granted after receiving a recommendation from the Committee for Orphan Medicinal Products (COMP).