N8Medical has entered into a CRADA with USAMRIID in support of Core Antibiotic Screening Program. Will test CSAs against biodefense pathogens including Anthrax.
PARK CITY, UTAH, UNITED STATES OF AMERICA, August 17, 2023/EINPresswire.com/ — USAMRIID will test 6 of N8 Medical’s Ceragenin1 compounds. N8 Medical and its drug development subsidiary Kinnear Pharmaceuticals has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Md. Under this CRADA in support of the Core Antibiotic Screening Program, USAMRIID will initially test 6 different CSA against five different biodefense pathogens (30 strains each), including anthrax, to determine which, if any of the compounds will progress to animal testing models at USAMRID and potentially FDA approval.
“We are pleased to have USAMRIID as a partner to test the potential utility of our Ceragenin compounds” stated Carl Genberg, CEO of Kinnear Pharmaceuticals. “The expertise of USAMRIID researchers in testing our agents to combat infectious diseases offers the best opportunity to evaluate compounds for these important applications.”
Since 1969, USAMRIID has provided leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Institute is the only laboratory in the Department of Defense equipped to safely study highly hazardous viruses requiring maximum containment at Biosafety Level 4. Research conducted at USAMRIID leads to vaccines, drugs, diagnostics, and training programs that protect both Warfighters and civilians. The Institute’s unique science and technology base serves not only to address current threats to our Armed Forces but is an essential element in the medical response to any future biological threats that may confront our nation
Ceragenins are small molecule non-peptide mimics of endogenous antimicrobial peptides that form a key part of the human body’s innate immune system that have broad spectrum antimicrobial activity and secondary immunomodulatory activities. Kinnear Pharmaceuticals is developing an inhaled drug to prevent/treat Pseudomonas lung infections that afflict Cystic Fibrosis patients with funding support from the Cystic Fibrosis Foundation. The FDA recently granted CSA-131 a QIDP designation pursuant to the GAIN Act for Pseudomonas lung infections in CF patients. CSA-131 is also used to coated indwelling medical devices such as endotracheal tubes to prevent biofilm fouling by pathogenic agents that may lead to Ventilator Associated Pneumonia, a common, costly and deadly complication of ICU mechanical ventilation. The FDA has designated our CeraShield Endotracheal Tube as a “breakthrough device’ pursuant to the 21st Century Cures Act and the device is currently approved in Canada, Brazil, Colombia and other ex US countries.
About the “Animal Rule”
Certain applications may proceed to FDA approval pursuant to the “animal rule” as it is unethical to expose humans to bioterror pathogens to evaluate efficacy. Approval for such applications is based on showing efficacy in the animal model and safety in healthy humans. Compounds that obtain FDA approval for such medical countermeasures (MCMs) are eligible for Priority Review Vouchers, see https://www.fda.gov/media/110193/download. PRV vouchers are available for medical countermeasures, neglected tropical diseases and certain pediatric drugs. Sarepta recently sold its PRV voucher for $102 million for its rare pediatric disease drug. https://www.businesswire.com/news/home/20230705080072/en/Sarepta-Therapeutics-Announces-Sale-of-Priority-Review-Voucher-for-102-million.
[The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.]
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