Cadrenal Therapeutics announced that it has completed an End-of-Phase 2 (EOP2) meeting with the FDA and received guidance on the Phase 3 pivotal trial design for CAD-1005, its investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). The FDA provided direction on protocol design, study population, dosing, background therapy, exposure, the size and scope of the safety database, and the primary endpoint of new or worsening thrombotic events. Based on this feedback, Cadrenal plans to proceed directly to a randomized, blinded, placebo-controlled Phase 3 registration study evaluating CAD-1005 added to standard-of-care anticoagulant therapy in patients with HIT.
According to the company, Phase 2 data for CAD-1005 in HIT showed a greater than 25% absolute reduction in thrombotic events when CAD-1005 was added to standard anticoagulant therapy. The planned pivotal Phase 3 trial will enroll approximately 120 patients with suspected HIT across up to 50 clinical centers worldwide and is intended to support a projected New Drug Application submission in 2029. In the study, patients will be randomized to receive CAD-1005 or placebo while on standard-of-care anticoagulant treatment and will be treated for up to 14 days during hospitalization.
The primary endpoint of the Phase 3 trial will be the centrally adjudicated incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one interim analysis planned. CAD-1005 is being investigated for the treatment of immune-mediated thrombocytopenia by targeting underlying pathophysiologic mechanisms not addressed by current therapies, with the goal of interrupting platelet activation in HIT.
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