3K3A-Activated Protein C (3K3A-APC) is an experimental drug for the treatment of stroke developed by ZZ Biotech.[1] It is also being assessed for the treatment of Alzheimer's disease.[2] It is the subject of RHAPSODY, a phase II trial to determine safety and tolerability.[3]
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| Other names | 3K3A-APC |
| Routes of administration | Intravenous |
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A phase III trial, RHAPSODY-2, to determine safety and efficacy for treatment of ischemic stroke, is planned.[4] However, on November 16, 2023, the National Institutes of Health (NIH) paused the start of the human trial of 3K3A-APC after an investigation by Science Magazine.[5]
The drug was designed to have more activity at protease-activated receptor 1 (PAR-1) and less anticoagulative effect than activated protein C.[6]
References
edit- ^ "First Patients Dosed in Phase 2 Trial of 3K3A-APC in ALS". Neurology live. 2021-12-03. Retrieved 2023-12-01.
- ^ "3K3A-Activated Protein C (3K3A-APC)" (PDF). alzdiscovery.org. April 1, 2019.
- ^ Lyden, Patrick; Pryor, Kent E.; Coffey, Christopher S.; Cudkowicz, Merit; Conwit, Robin; Jadhav, Ashutosh; Sawyer, Robert N.; Claassen, Jan; Adeoye, Opeolu; Song, Shlee; Hannon, Peter; Rost, Natalia S.; Hinduja, Archana; Torbey, Michel; Lee, Jin-Moo (January 2019). "Final Results of the RHAPSODY Trial: A Multi-Center, Phase 2 Trial Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC, A Recombinant Variant of Human Activated Protein C, in Combination with Tissue Plasminogen Activator, Mechanical Thrombectomy or both in Moderate to Severe Acute Ischemic Stroke". Annals of Neurology. 85 (1): 125–136. doi:10.1002/ana.25383. ISSN 1531-8249. PMC 6342508. PMID 30450637.
- ^ "Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY-2)". clinicaltrials.gov. Retrieved 2023-12-02.
- ^ Piller, Charles (2023-12-02). "NIH puts hold on $30 million trial of potential stroke drug". Science. Archived from the original on 2023-12-02. Retrieved 2023-12-02.
- ^ Lyden, Patrick; Levy, Howard; Weymer, Sara; Pryor, Kent; Kramer, William; Griffin, John H.; Davis, Thomas P.; Zlokovic, Berislav (2013). "Phase 1 Safety, Tolerability and Pharmacokinetics of 3K3A-APC in Healthy Adult Volunteers". Current Pharmaceutical Design. 19 (42): 7479–7485. doi:10.2174/1381612819666131230131454. ISSN 1381-6128. PMC 4040367. PMID 24372304.
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