Verseon gets approval for VE-1902 clinical trial

13th Sep 2018 08:06

(Sharecast News) - Technology-based pharmaceutical company Verseon has received ethics committee approval and acknowledgement from the Therapeutic Goods Administration in Australia for the phase I clinical trial of VE-1902, it announced on Thursday.The AIM-traded firm said VE-1902 was the first clinical candidate from its novel class of precision oral anticoagulants (PROACs).It said its PROACs, in preclinical testing, showed a "unique combination" of efficacy with low bleeding, potentially making them suitable for stroke prevention in atrial fibrillation or prolonged co-administration with antiplatelet drugs for patients with coronary artery disease."Verseon's precision oral anticoagulants provide an exciting opportunity to develop a safe approach to long-term combination therapy with antiplatelet drugs to reduce strokes and heart attacks in patients with coronary artery disease," said John Deanfield, professor of cardiology at University College London.The primary goal of the double-blinded, randomised, placebo-controlled phase I trial was to study the safety, tolerability, and composite hemostatic profile of VE-1902 in healthy volunteers.Secondary endpoints would assess pharmacokinetic and pharmacodynamic profiles.The study would be conducted in two stages investigating once-a-day oral dosing in tablet form - a single ascending dose stage with a food effect comparison cohort, and a multiple ascending dose stage with seven-day repeat dosing."The clinical evaluation of VE-1902 is an important step in bringing safer antithrombotic treatment to patients worldwide," said Verseon's chief executive officer Adityo Prakash."We look forward to clinical trial results from this program and from others in our growing drug development pipeline."