Amplia Therapeutics (ASX:ATX) is progressing thee Phase 2a stage of the ACCENT trial involving its FAK-inhibitor narmafotinib in combination with gemcitabine and abraxane.
In late 2023, the company reported on the completion of the Phase 1b stage of the trial. Fourteen (14) patients were dosed over three dose levels. Seven patients remained on trial for more than 6 months, with two being on trial for more than 10 months. The company said six patients have now recorded a partial response as the best response, with the remaining eight recording stable disease. Three patients remain on trial from the Phase 1b cohort.
The Phase 2a stage will initially enrol 26 patients over the coming months at six trial sites in Australia and five trial
sites in South Korea. Eleven patients have now been recruited.
The company said an interim analysis of efficacy will be conducted around the third quarter of 2024.
Amplia CEO and managing director Dr Chris Burns said, “The clinical responses we are seeing in patients from
the Phase 1b stage is very promising. The duration on trial, given the aggressiveness of the disease in these patients, is also extremely encouraging. As reported at the end of our Phase 1b trial, the drug
safety and tolerability also appears to be very acceptable for this patient group. We look forward to
reporting on further data from the trial as the Phase 2a patients are assessed.”