The trial will enrol nearly 20 myelofibrosis patients. Credit: Arek Socha from Pixabay.

Imago BioSciences has dosed the first subject in the Phase II clinical trial of bomedemstat plus ruxolitinib (Jakafi) in myelofibrosis (MF) patients. 

Being carried out at the Department of Medicine, Queen Mary Hospital and the University of Hong Kong, the investigator-sponsored, open-label trial will enrol nearly 20 subjects.

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These MF patients should be either naïve or refractory to JAK inhibitor, relapsed or not tolerant to ruxolitinib.

It will evaluate the safety and efficacy of bomedemstat plus ruxolitinib for 28 days.

A lead product candidate of the company, bomedemstat is an investigational oral small molecule inhibitor of lysine-specific demethylase 1 (LSD1). 

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Bomedemstat has received Orphan Drug and Fast Track Designation from the US Food and Drug Administration (FDA) for treating essential thrombocythemia (ET) and MF. 

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A kinase inhibitor, ruxolitinib has received the US Food and Drug Administration (FDA) approval to treat various indications, including intermediate or high-risk MF.

Imago BioSciences CEO Hugh Rienhoff said: “We are excited that the University of Hong Kong has interest in exploring the potential use of bomedemstat in combination with ruxolitinib for the treatment of myelofibrosis. 

“Bomedemstat, through the inhibition of LSD1, regulates stem cell activity as well as the maturation of megakaryocytes, both of which are key to the pathophysiology of MF. 

“This study explores the possibility that this new combination regimen will serve as a treatment option for patients who have had inadequate symptom relief or spleen volume reduction with ruxolitinib alone.”

In Phase II trials underway, bomedemstat showed to be well-tolerated and offered substantial improvement in symptoms in MF and ET patients.

In December 2020, the company extended the international Phase IIb trial of bomedemstat into Hong Kong.