BROOMFIELD, Colo. (PRWEB)
August 02, 2022

Aktiv Pharma Group (Aktiv) announced today a grant award from the U.S. Department of Defense (DOD) Defense Health Agency (DHA) Joint Program Committee 6/Combat Casualty Care Research Program (JPC-6/CCCRP) [1] for the continued development of their tranexamic acid (TXA) autoinjector, targeting proposed indications related to prehospital treatment of severe bleeding.

“We are excited to receive this support from the U.S. Government to develop yet another one of the critically important emergency treatment products” said the company founder and CEO, Amir Genosar. “This award will help Aktiv continue advancing the TXA autoinjector towards FDA approval in 2025, which will ultimately be used to help protect both our troops and the civilian population.” To date, Aktiv has met several critical milestones in the TXA autoinjector program, including development of a proprietary formulation, performing stability studies, and completing a number of promising preclinical studies.

Uncontrolled bleeding is the number one cause of death on the battlefield and pre-hospital treatment options prior to evacuation to definitive care are limited [2]. Furthermore, it is estimated that 18,400 preventable deaths occur each year in the U.S. alone due to hemorrhage after injury [3]. “We are proud to develop a product that will be available for the U.S. Warfighter and emergency medical responders to treat patients in the field as close as possible to the time of injury, with an autoinjector that meets and exceeds the most stringent reliability requirements of the U.S. Food and Drug Administration (FDA) for emergency-use injectors”.

The ARAI autoinjector has been developed by Aktiv with the support of the DOD and the U.S. Department of Health and Human Services (HHS) Biotechnology Advanced Research and Development Authority (BARDA) as a next generation autoinjector platform to address the shortfalls of previous autoinjectors, by improving usability, reliability, robustness, and drug stability. ARAI is a versatile platform that can deliver up to 5 ml dose volumes, perform simultaneous injections of multiple, separately stored drug formulations, and automatically reconstitute drugs formulated in dry form. Aktiv is currently expanding the ARAI platform to include a consumer market autoinjector for biopharmaceuticals that will feature the same reliability, robustness, and usability benefits in a smaller form factor and with added data connectivity.

Aktiv is leveraging its superior autoinjector technology to advance the strongest emergency treatment pipeline in the industry, which currently includes atropine, pralidoxime chloride (2-PAM), atropine/2-PAM dual-injection, and scopolamine in development as a treatment for nerve agent poisoning, and is planning to add at least one more emergency treatment to its pipeline by 2023. Aktiv is also collaborating with another pharmaceutical company to develop a reconstitution autoinjector for a long-acting formulation of naloxone. “We are humbled by the opportunities entrusted to us by the U.S. Government to help save lives from trauma injuries, to protect our military and the homeland from unconventional weapon threats, and to improve our response to mass casualty events”, Mr. Genosar added.

The University of Colorado School of Medicine’s CU Anschutz Center for Combat Medicine and Battlefield (COMBAT) Research and Dr. Vik Bebarta’s TRIAD Research Lab are a lead collaborator on this important, practice-changing award that will benefit our warfighters and warrior medics. “These key industry and academic partnerships provide the DOD a timely opportunity to get solutions out the door and into practice” said Dr. Bebarta, the founder and director of the CU Center for COMBAT Research on the CU Anschutz Medical Campus. “The University of Colorado School of Medicine and the CU Center for COMBAT Research in the Department of Emergency Medicine are excited to collaborate with our local Colorado partner, Aktiv, on this effort to change how we care for our service members in garrison and our civilians in our communities.”

About Aktiv

Aktiv is a vertically integrated specialty pharmaceutical company with combination product contract development and manufacturing organization (CDMO) capabilities, developing, manufacturing, and commercializing sterile injectable products in a portfolio of proprietary, value-added, glass-free prefilled delivery systems. Aktiv’s has unique combination product competencies, specifically targeting biopharmaceuticals. The company’s facilities in Colorado include device development, chemistry, manufacturing and controls (CMC), and manufacturing equipment labs, assembly rooms operated under Good Manufacturing Practice (GMP), and sterile fill-finish suites. Aktiv can be contacted at https://aktivpharmagroup.com/contact.

[1] The funding is provided by the Office of the Assistant Secretary of Defense for Health Affairs, through the U.S. Army Medical Research and Development Command under Award No. W81XWH-22-1-0225. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. In conducting research using animals, the investigator(s) adheres to the laws of the United States and regulations of the Department of Agriculture.

[2] Eastridge, Brian J et al. “Outcomes of traumatic hemorrhagic shock and the epidemiology of preventable death from injury.” Transfusion vol. 59,S2 (2019): 1423-1428.

[3] Spinella, Philip Charles. “Zero preventable deaths after traumatic injury: An achievable goal.” The journal of trauma and acute care surgery vol. 82,6S Suppl 1 (2017): S2-S8.

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