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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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. 

See Also:

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. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.