The early-stage trial will study safety, pharmacokinetics, and pharmacodynamics of VE-1902 in 100-120 participants. The blood thinner is the first PRrecision Oral AntiCoagulant (PROAC) of the US-based pharma company to enter into clinical development.
Verseon said that PROACs during preclinical testing demonstrated a unique combination of efficacy with lower bleeding. It further said that PROACs, in particular, have shown the ability to stop the formation of blood clots without disrupting the function of platelets.
The company said that the preclinical data indicate that PROACs could turn out to be the first anticoagulants that can be used for long-term co-administration with antiplatelet agents for preventing stroke and heart attack in coronary artery disease (CAD) patients.
According to the clinical-stage company, VE-1902 was well-tolerated in regulatory toxicity studies and had shown low renal clearance, which is a desirable property for patients with impaired kidney function.
The phase 1 clinical trial, which is a single-center, double-blinded, randomized, placebo-controlled study, will also evaluate the tolerability, and composite hemostatic profile of the company’s lead candidate.
Secondary endpoints of the trial will evaluate VE-1902’s pharmacokinetic and pharmacodynamic profiles.
The phase 1 trial of the PROAC will include daily-once oral dosing in two stages. The first will be a single ascending dose stage with a food effect cohort while the other will be a multiple ascending dose stage with seven-day repeat dosing.
Verseon expects to continue dosing patients with Verseon PROAC through Q3 2019 with first results expected to come out in the fourth quarter of this year.
Verseon R&D VP David Kita said: “The start of subject dosing is an exciting milestone for Verseon.
“PROACs have the potential to change the standard of care for millions of CAD patients who would benefit from long-term combination therapy with antiplatelet drugs. We look forward to the results of VE-1902 in this first-in-human trial.”
Verseon expects another of its PROACs to enter into clinic development this year.