Chemistry:3K3A-Activated Protein C

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Short description: Experimental drug for the treatment of stroke

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]

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

  1. ↑ "First Patients Dosed in Phase 2 Trial of 3K3A-APC in ALS" (in en). 2021-12-03. https://www.neurologylive.com/view/first-patients-dosed-phase-2-trial-3k3a-apc-als. 
  2. ↑ "3K3A-Activated Protein C (3K3A-APC)". April 1, 2019. https://www.alzdiscovery.org/uploads/cognitive_vitality_media/3K3A-APC-Cognitive-Vitality-For-Researchers.pdf. 
  3. ↑ Lyden, Patrick; Pryor, Kent E.; Coffey, Christopher S.; Cudkowicz, Merit; Conwit, Robin; Jadhav, Ashutosh; Sawyer, Robert N.; Claassen, Jan et al. (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. PMID 30450637. 
  4. ↑ "Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY-2)". https://clinicaltrials.gov/study/NCT05484154. 
  5. ↑ Piller, Charles (2023-12-02). "NIH puts hold on $30 million trial of potential stroke drug". https://www.science.org/content/article/nih-puts-hold-30-million-trial-potential-stroke-drug. 
  6. ↑ 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. PMID 24372304. 




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