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Other names | 3K3A-APC |
Routes of administration | Intravenous |
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3K3A-Activated Protein C (3K3A-APC) is an experimental drug for the treatment of stroke developed by ZZ Biotech. It is also being assessed for the treatment of Alzheimer's disease. It is the subject of RHAPSODY, a phase II trial to determine safety and tolerability.
A phase III trial, RHAPSODY-2, to determine safety and efficacy for treatment of ischemic stroke, is planned. 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.
The drug was designed to have more activity at protease-activated receptor 1 (PAR-1) and less anticoagulative effect than activated protein C.
References
- "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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