Technology-based pharma company, Verseon, has submitted a Phase I clinical trial protocol for its lead precision oral anticoagulant (PROAC) — VE-1902 — to the Bellberry Human Research Ethics Committee (HREC) in Australia.
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The proposed study will be a double-blinded, randomised, placebo-controlled trial to assess the safety and tolerability of VE-1902 tablets in healthy volunteers who will be given once-daily oral dosing.
It is expected that the Phase I trial will start in the third quarter of the year once approval has been received from the HREC and there has been acknowledgement by the Therapeutic Goods Administration.
“VE-1902 has continued to demonstrate its excellent profile in preclinical testing and successfully completed all regulatory studies leading up to today’s submission for first-in-human clinical trials,” said Dr David Kita, vice president of R&D at Verseon. “We are looking forward to confirming its distinctive profile in human trials.”
This PROAC therapy from Verseon is the first clinical candidate from the company and has shown good efficacy in several preclinical studies without disrupting platelet function. It is this latter feature that may explain the low bleeding risk that has been seen and may enable this class of drug to be the first oral anticoagulants suitable for long-term anti-coagulant-antiplatelet combination therapy.