-- Syntara (ASX:SNT) received positive feedback from the US Food and Drug Administration following a type C meeting, supporting the design of its planned phase 2b clinical trial of amsulostat for the treatment of myelofibrosis, according to a Tuesday filing with the Australian bourse.
The primary endpoint of the phase 2b study will be the achievement of a 50% reduction in the total symptom score following nine months of treatment, with about 100 patients expected to be enrolled, per the filing.
The positive feedback from the US FDA allows for amsulostat's progression into late-stage clinical development and paves the way for further engagement with prospective commercial partners, the company said.
Myelofibrosis is a type of bone marrow cancer where the accumulation of scar tissue leads to a loss of red and white blood cells and platelets.