Prescient Therapeutics (ASX: PTX) has been granted fast-track designation by the US Food and Drug Administration (FDA) for its lead candidate, PTX-100, aimed at treating adults suffering from relapsed or refractory mycosis fungoides. This skin condition, a subtype of cutaneous T-cell lymphoma (CTCL), represents a significant unmet medical need. The FDA’s fast-track process is designed to accelerate the development and review of therapies that address serious conditions, facilitating earlier access for patients through improved regulatory pathways for drug manufacturers.
According to Prescient CEO James McDonnell, the fast-track designation underscores PTX-100’s potential as a valuable treatment option for mycosis fungoides. The company has completed the first site initiation visit for a Phase 2a clinical study of PTX-100 in Melbourne, Australia. This open-label trial will assess two dosage levels in approximately 40 patients with relapsed/refractory CTCL across sites in Australia, the US, and Europe. Earlier Phase 1b study results showed a 42% overall response rate among evaluable TCL patients, with a median progression-free survival rate exceeding 10 months, surpassing the standard treatment’s typical PFS. This progress aims to expedite PTX-100 into a registration-enabling trial, supporting accelerated approval and commercialization.
