Faron announces promising MDS trial results

Faron Pharmaceuticals announced promising interim phase two results from its ‘BEXMAB’ trial on Wednesday, targeting relapsed or refractory myelodysplastic syndrome (r/r MDS) patients.

The AIM-traded firm said the results, which confirmed earlier findings from phases one and two, would be presented at the 66th American Society of Hematology (ASH) annual meeting next month.

It said the trial was focussed on patients who had failed prior treatment with hypomethylating agents (HMAs), a population with historically limited therapeutic options.

Among 20 evaluable patients treated with a combination of Faron's bexmarilimab and azacitidine, the objective response rate (ORR) reached 80%.

That marked a significant improvement compared to the 0% to 20% ORR typically observed with existing alternatives for this patient group, Faron noted.

Patients in the BEXMAB trial also demonstrated a median overall survival (mOS) of around 13.4 months, more than double the five to six months typically observed under standard care.

The combination therapy was well tolerated, with no dose-limiting toxicities reported.

Faron said the findings underlined the potential of bexmarilimab, its novel immunotherapy, to deliver deep and durable responses in a patient population with significant unmet needs.

Recruitment for the BEXMAB trial was continuing as planned, with a full efficacy data readout anticipated by the end of the first quarter of next year.

“It is remarkable seeing the ORR continuing to be so strong even as the patient population grows, as it would typically be expected to settle at a lower level,” said chief executive officer Dr Juho Jalkanen.

“For patients, I believe these results are truly exciting as we take another step closer to providing an additional option for their poorly met treatment needs.

“With our repeatedly strong data, we are very much looking forward to our continuing discussions with regulatory agencies and partner candidates.”

At 1044 GMT, shares in Faron Pharmaceuticals were up 6.41% at 170.25p.

Reporting by Josh White for Sharecast.com.