OKL-1111 / Alveron Pharma - LARVOL DELTA

A first-in-human study evaluating safety, PK, and PD of a novel universal anticoagulant reversal agent, OKL-1111. (PubMed, Blood Vessel Thromb Hemost) - "In addition, the pharmacodynamic (PD) response to OKL-1111 in the absence and presence of dabigatran or apixaban was assessed ex vivo. However, development of OKL-1111 was discontinued after completion of this first-in-human study because of safety findings in subsequent repeat-dose animal toxicology studies. This trial was registered at www.clinicaltrialsregister.eu as EudraCT2022-003463-19."

First-in-human • Journal • P1 data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Thrombosis

First in-Human Study with Okl-1111, a Novel Small Molecule Universal Anticoagulant and Platelet Inhibitor Reversal Agent (ASH 2024) - "OKL-1111 reversed the action of a wide variety of anticoagulants (dabigatran, apixaban, rivaroxaban, edoxaban, warfarin, enoxaparin and fondaparinux) as well as platelet inhibitors (ticagrelor and clopidogrel) in vivo without any sign of thrombotic overshoot. OKL-1111 at a single dose of 1000mg reduced the dabigatran-induced lagtime increase in TGA. Discussion : OKL-1111, to our knowledge the first fully universal reversal agent and the only clopidogrel reversal agent, can be safely administered to volunteers up to 1000mg, without (serious) adverse events."

First-in-human • P1 data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Thrombosis

First in-Human Study with Okl-1111, a Novel Small Molecule Universal Anticoagulant and Platelet Inhibitor Reversal Agent (ASH 2024) - "OKL-1111 reversed the action of a wide variety of anticoagulants (dabigatran, apixaban, rivaroxaban, edoxaban, warfarin, enoxaparin and fondaparinux) as well as platelet inhibitors (ticagrelor and clopidogrel) in vivo without any sign of thrombotic overshoot. OKL-1111 at a single dose of 1000mg reduced the dabigatran-induced lagtime increase in TGA. Discussion : OKL-1111, to our knowledge the first fully universal reversal agent and the only clopidogrel reversal agent, can be safely administered to volunteers up to 1000mg, without (serious) adverse events."

First-in-human • P1 data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Thrombosis