Priothera has announced plans to commence the pivotal Phase IIb/III MO-TRANS clinical trial of its investigational drug, mocravimod (KRP203), in acute myeloid leukaemia (AML) patients undergoing allogeneic hematopoietic stem cell transplant (HSCT).

The company plans to commence the trial in the second half of this year with preliminary findings anticipated by the end of 2024.

The latest move comes after the US Food and Drug Administration (FDA) granted clearance for the company’s Investigational New Drug (IND) application to initiate the trial.

Mocravimod is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator compound.

To be launched in Europe, US and Japan, the global trial will analyse the safety and efficacy of mocravimod as an adjunctive and maintenance treatment in adult AML patients. 

The sole potentially curative option for AML patients is allogenic stem cell transplantation but existing therapy options are still linked to an increased number of side effects and death rates. 

Priothera co-founder and CEO Florent Gros said: “The FDA IND clearance to initiate the MO-TRANS study assessing mocravimod in AML patients undergoing allogeneic HSCT is another major milestone for Priothera. 

“We are on track to initiate this pivotal Phase IIb/III clinical trial and are looking forward to working alongside a large team of enthusiastic investigators across the US, Europe and Asia, who share our goal of bringing mocravimod to patients as an adjunctive and maintenance treatment for AML and potentially other hematologic malignancies.”

Mocravimod was previously evaluated in Phase I and II trials for safety and tolerability, as well as for efficacy in various autoimmune indications. 

Promising findings were obtained from a Phase Ib/IIa trial in individuals with haematological malignancies, facilitating the company to further develop the drug for blood cancers.