3K3A-Activated Protein C explained

Drug Name:3K3A-Activated Protein C
Routes Of Administration:Intravenous
Legal Status:Investigational
Synonyms:3K3A-APC
Cas Number:1421330-93-9

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]

Notes and References

  1. Web site: 2021-12-03 . First Patients Dosed in Phase 2 Trial of 3K3A-APC in ALS . 2023-12-01 . Neurology live . en.
  2. Web site: April 1, 2019 . 3K3A-Activated Protein C (3K3A-APC) . alzdiscovery.org.
  3. 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 . 10.1002/ana.25383 . 1531-8249 . 6342508 . 30450637.
  4. Web site: Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY-2). 2023-12-02 . clinicaltrials.gov.
  5. Web site: Piller . Charles . 2023-12-02 . NIH puts hold on $30 million trial of potential stroke drug . https://web.archive.org/web/20231202224352/https://www.science.org/content/article/nih-puts-hold-30-million-trial-potential-stroke-drug . 2023-12-02 . 2023-12-02 . Science.
  6. Lyden . Patrick . Levy . Howard . Weymer . Sara . Pryor . Kent . Kramer . William . Griffin . John H. . Davis . Thomas P. . Zlokovic . Berislav . Phase 1 Safety, Tolerability and Pharmacokinetics of 3K3A-APC in Healthy Adult Volunteers . Current Pharmaceutical Design . 2013 . 19 . 42 . 7479–7485 . 10.2174/1381612819666131230131454 . 24372304 . 4040367 . 1381-6128.

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