Acticor Biotech has reported positive results from its Phase I clinical trial of ACT017 to treat acute phase of thrombotic diseases, including stroke and other thrombosis disorders such as pulmonary embolism.
The randomised, double-blind, placebo-controlled single escalating dose study was conducted in QPS’s clinical research centre in the Netherlands.
It enrolled 48 healthy subjects who were distributed in six dose level cohorts with each set comprising eight subjects, with six of them on active and two placed on placebo to receive the subsequent doses of 62.5mg, 125mg, 250mg, 500mg, 1,000mg, and 2,000mg.
The trial met its primary endpoint of evaluating safety and tolerability of ACT017 in the enrolled subjects, with no serious adverse event reported at any of the doses tested.
However, the trial has not achieved the maximum tolerated dose, despite the complete inhibition of collagen-induced platelet aggregation. This means that ACT017 has achieved acceptable Phase ll recommended dose.
Acticor Biotech CEO Gilles Avenard said: “While waiting for the full results of the clinical trial, which should be available in the coming weeks, we are working actively on the design and the organisation of the first Phase II clinical study with ACT017 in the acute phase of ischemic stroke.”
Study results will help Acticor determine the most appropriate ACT017 dosage for new Phase II studies.
ACT017 drug is a humanised monoclonal antibody fragment (Fab) designed to target a platelet glycoprotein (GPVI) involved in thrombosis.