Verseon submits phase I protocol for precision oral anticoagulant VE‑1902 to regulatory authorities
Fremont, Calif.—Verseon (AIM:VSN),Verseon, a technology-based pharmaceutical company, today announces that it has submitted a phase I clinical trial protocol for VE‑1902, its lead PROAC (precision oral anticoagulant), to the Bellberry Human Research Ethics Committee (HREC) in Australia. The proposed study is a double-blinded, randomized, placebo-controlled phase I trial to assess the safety and tolerability of VE‑1902 tablets in healthy volunteers with once-a-day oral dosing. The phase I trial is expected to start in Q3 2018, after approval by the HREC and acknowledgment by the Therapeutic Goods Administration.
VE‑1902 is the first clinical candidate from Verseon's novel class of PROACs, which have shown good efficacy in multiple preclinical studies but do not disrupt platelet function. This unique feature could explain the low bleeding risk of these precision anticoagulants and may allow PROACs to become the first oral anticoagulants suitable for long-term anticoagulant-antiplatelet combination therapy.
"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."
About Verseon's PROACs
Verseon's precision oral anticoagulants (PROACs) are potent, highly selective, reversible covalent inhibitors of thrombin. PROACs have shown excellent efficacy in multiple preclinical studies but do not disrupt platelet function. This unique feature could explain the low bleeding risk of these precision anticoagulants and makes them excellent candidates for use in long-term combination anticoagulant-antiplatelet therapy. The lead PROAC VE‑1902 is scheduled to enter clinical trials in mid-2018. VE‑1902 was well-tolerated in regulatory tox studies and has demonstrated very low renal clearance, a highly desirable property for patients with impaired kidney function. A second PROAC is expected to enter the clinic in 2019.
Verseon Corporation
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