Faron Pharmaceuticals Limited (AIM:FARN) said it plans to meet with the US Food & Drug Administration earlier than planned in the hope of fast-tracking its lead drug, which has shown huge promise in treating a type of rare blood cancer.
This is one of the key priorities of the incoming CEO, Dr Juho Jalkanen, set out in an update issued on Tuesday.
Faron said it would seek what's called a scientific advice meeting with the regulator "regarding its registrational study plan in order to coordinate and finalise plans that may lead to marketing approval" for its key asset, bexmarilimab.
The move follows promising data from the phase I trials involving patients with myelodysplastic syndrome (MDS) who were unresponsive to a class of drugs called hypomethylating agents (HMAs).
"There is a tremendous need for an effective treatment in HMA-failed MDS patients and so we are very keen to ensure we get this treatment option to patients as soon as we can," said Jalkanen.
In the update, investors were told Faron is set to release initial phase II data from its BEXMAB trial during the week starting May 20.
This study was designed to assess the effectiveness and safety of bexmarilimab combined with the standard in this group of HMA-failed MDS patients.
The results are crucial for Faron's discussions on potential partnerships and will be a focal point at major industry events such as the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention in June.
"2024 is set to be a pivotal year for Faron in the delivery of key milestones that will be critical to the further development of bexmarilimab," said Jalkanen.
"In my new role as CEO I am excited to start executing on some of these key activities and to accelerate important discussions with the FDA as we map our future plans for bexmarilimab together."