Feb 11, 2019
Fremont, Calif.—Verseon, the clinical-stage pharmaceutical company developing disruptive life-science technology to advance global health, presented its PROACs (PRecision Oral AntiCoagulants) at last week’s International Stroke Conference in Honolulu, HI. Due to their novel combination of efficacy, low bleeding, and sparing of platelet function that was observed in preclinical testing, PROACs could become the first anticoagulants suitable for long-term co-administration with antiplatelet drugs for patients with coronary artery disease.
Millions of patients worldwide could benefit from safe, long-term therapy combining an oral anticoagulant with one or more antiplatelet drugs (i.e. aspirin, PlavixTM) to prevent stroke or heart attack. With current anticoagulants, however, such combination treatment is generally limited to 12 months because of an increased risk of major bleeding. Verseon’s PROACs have demonstrated significantly reduced bleeding in preclinical studies, which could make them uniquely suited for these patients.
In contrast to conventional pharma companies that typically rely on a single compound per program, Verseon is using its computer-driven drug development platform to generate multiple chemically distinct drug candidates for each disease area. As a result, the company is currently conducting a phase 1 trial on the lead PROAC, VE-1902, and expects to also advance a second PROAC, VE-2851, into clinical trials.
At the International Stroke Conference, Dr. Mohan Sivaraja, Verseon’s Director of In Vitro Discovery Biology, presented the preclinical profiles of both clinical candidates. Dr. Sivaraja presented preclinical efficacy models showing that PROACs inhibit clot formation as effectively as currently available therapies, along with multiple safety studies showing less bleeding and a sparing of platelet function—features that distinguish PROACs from the currently available NOACs and make them promising therapeutic candidates.
“Our preclinical studies have shown that PROACs have a distinct pharmacological profile that sets them apart from NOACs,” said Dr. Sivaraja. “PROACs inhibit clots without disrupting platelet function. This explains their lower bleeding in preclinical models and makes them promising alternatives for a large number of patients who need long-term combination therapy with antiplatelet medication. We are excited to bring these compounds one step closer to patients.”
“A Study of Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of VE-01902 in Healthy Volunteers”
The phase I trial for Verseon’s first PROAC, VE-1902, (trial ID ACTRN12618001509257) is a single-center, double-blinded, randomized, placebo-controlled study of the safety, tolerability, and composite hemostatic profile in 100–120 healthy volunteers. Secondary endpoints will assess pharmacokinetic and pharmacodynamic profiles of VE-1902. The study will include once-a-day oral dosing in two stages: a single ascending dose stage with a food effect cohort and a multiple ascending dose stage with 7-day repeat dosing. The trial is being conducted at Nucleus Network in Melbourne, Australia.
Verseon’s PRrecision Oral AntiCoagulants (PROACs) have shown excellent efficacy in multiple preclinical studies without disruption of platelet function. This unique feature could explain the low bleeding of the PROACs observed in preclinical testing, making PROACs excellent candidates for use in long-term combination anticoagulant-antiplatelet therapy. Lead PROAC VE-1902, which is currently in a phase I clinical trial, was well-tolerated in regulatory toxicity studies and demonstrated low renal clearance, a desirable property for patients with impaired kidney function. A second PROAC is expected to enter the clinic in 2019.
Verseon Corporation (www.verseon.com, AIM: VSN) is a technology-based pharmaceutical company that pairs a proprietary, computational drug discovery platform with a comprehensive in-house chemistry and biology workflow to develop novel therapeutics that are unlikely to be found using conventional methods. The Company is applying its platform to a growing drug pipeline and currently has four active drug programs in the areas of anticoagulation, diabetic macular edema, hereditary angioedema, and oncology.
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