
Helixomer Completes Landmark Study: Hex01 Shows Cross-Species Efficacy, Antiplatelet Activation Activity, and a Clear Path to IND to Finally Replace Heparin-Protamine
David Harrell
Friday, May 15, 2026
Helixomer has completed a comprehensive preclinical study covering two years of work on Hex01 (anticoagulant) and Hex02 (matched reversal agent), with a manuscript now headed for journal submission.
Key results:
Cross-species activity: Hex01 demonstrated anticoagulant activity in blood from seven mammalian species — human, monkey, dog, pig, rabbit, rat, and mouse. Hex02 reliably and immediately reversed it in all cases.
Superior potency: In human blood, Hex01 was approximately 25 times more potent than bivalirudin at inhibiting platelet activation and aggregation — the first time a single molecule of this class has demonstrated simultaneous anticoagulation and anti-platelet activity.
In vivo efficacy: In a standard murine ferric-chloride carotid challenge, Hex01 at 4 mg/kg prevented clotting as effectively as standard heparin dosing. Dose-dependent responses were demonstrated for both molecules.
Extended half-life, PEG-free: In rabbits, Hex01 achieved a half-life of 2–4 hours depending on dose, via RNA Origami architecture — without PEG. TNF-alpha and IL-6 remained normal throughout; no immune activation observed.
Tolerability: At maximum feasible dose with seven-day repeat dosing in rats, both Hex01 and Hex02 showed 100% survival and were well tolerated.
Shelf stability: Hex01 is stable at room temperature for more than 15 months in solution — eliminating the porcine supply chain vulnerability that continues to drive heparin shortages into 2028.
Existing anticoagulation and its reversal in acute critical care remains a problem; Hex01 and Hex02 designed to transform that.
Approximately 12 million Americans receive heparin annually. Roughly 8.5% develop heparin-induced thrombocytopenia (HIT), and 18% of HIT patients die. Clinicians have sought a controllable, synthetic, nonimmunogenic alternative for decades.
Hex01 and Hex02 are a credible, data-backed answer. We are advancing toward pivotal GLP toxicology studies required to file our IND. Reach out to learn more about our control-without-compromise approach.
