Faron launches second phase of leukaemia treatment trial

The AIM-traded firm said the trial would focus on evaluating the safety and effectiveness of bexmarilimab, a novel approach to reprogramming myeloid cells for anti-tumour immunity in patients with limited treatment options.

It said the trial targeted patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), a challenging form of myeloid leukaemia.

The condition typically has very few therapeutic alternatives.

Faron said the ongoing phase two portion of the trial was currently enrolling 32 patients who had failed previous HMA treatments, at two different dose levels of bexmarilimab - three and six milligrams per kilogram.

The trial design adhered to the FDA's Project Optimus initiative, with patients randomly assigned to receive either of the two dose levels in a one-to-one ratio.

After evaluating data from the first 20 patients - ten from each dose group - Faron said it planned to finalise the dosing, and initiate discussions with the FDA regarding a potential registrational study.

To expedite the trial's progress, Faron said it was actively opening additional trial sites.

Its primary goal was to accelerate the path to approval for patients with refractory higher risk MDS, who currently lacked effective treatment options.

Building on positive preliminary results, the company also said it was considering extending the scope of bexmarilimab's potential application.

That could include exploring its efficacy in treating low-risk MDS and chronic myelomonocytic leukaemia (CMML) patients currently undergoing HMA-based therapies.

Additionally, Faron said it was exploring partnership opportunities for further development and expansion of bexmarilimab in haematological cancers, with a commitment to advancing cancer treatment options.

“Dosing of the first patients in this advanced part of the BEXMAB study is another significant milestone in the bexmarilimab program, and we want to thank our clinical network again for the rapid advancement of our programme,” said chief medical officer Dr Birge Berns.

“Refractory and relapsed MDS represents a significant therapeutic challenge and based on the recently announced data at ASH from the phase one part of this trial, we believe that bexmarilimab has the potential to save and improve the lives of HMA-failed MDS patients.”

At 1152 GMT, shares in Faron Pharmaceuticals were up 7.29% at 316.5p.

Reporting by Josh White for Sharecast.com.