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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.”

About USAMRIID

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

About Ceragenins

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.]

For more information, see www.N8Medical.com and www.Kinnearpharma.com

Carl Genberg
N8 Medical
+1 702-285-5740
carlgenberg@kinnearpharma.com
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¹ https://www.n8medical.com/

FDA QiDP designation is a significant milestone

PARK CITY, UTAH, UNITED STATES, July 31, 2023/EINPresswire.com/ — Kinnear Pharmaceuticals, LLC, a subsidiary of N8 Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for CSA-131 for the prevention and treatment of life threatening Pseudomonas infections in patients with Cystic Fibrosis. CSA-131 is a synthetic non-peptide mimic of the endogenous antimicrobial peptide LL-37 which forms a key component of the body’s innate immune system which is essential to preventing and treating lung infections. Many patients with Cystic Fibrosis have recurrent lung infections from the potentially lethal Gram negative Pseudomonas aeruginosa bacterial pathogen as the activity of LL-37 is impaired by high salt concentration and sticky CF sputum that is characteristic of Cystic Fibrosis. This is based on the genetic impairment of the chloride ion channel in the mucous membranes of CF patients. Unlike LL-37, CSA-131’s antimicrobial activity is not deactivated by high salt concentrations or sticky mucous. The genetic defect in innate immunity in CF patients has been partially overcome by the development, FDA approval of introduction of Vertex Pharmaceuticals (NYSE:VRTX) revolutionary CFTR modulatory drugs. However, recurrent Pseudomonas bacterial lung infections still remain an important problem in this patient population and the Cystic Fibrosis Therapeutics Foundation has helped fund the development of CSA-131 to help meet this unmet medical need. The leading cause of early death in CF patients is recurrent Pseudomonas infections which destroy the elasticity of lung tissue making it impossible to breath. CF patients have an average life expectancy of 40 years.

“Pseudomonas aeruginosa is a common pathogen for patients with cystic fibrosis and ventilator associated pneumonia. It leads to high rates of morbidity and mortality due to its complex mechanisms of injury and relative resistance to antibiotic therapy. Prevention is key, but we need new approaches and the development of CSA-131 is a welcome advance” said Professor Michael Niederman, Chairman of N8 Medical’s Scientific Advisory Board. “Published research has shown that CSA-131 is highly effective against strains of Pseudomonas that are resistant to Tobramycin and Colistin, two commonly used anti-infective drugs” said Carl Genberg, CEO of Kinnear Pharmaceuticals. “The QIDP Designation shows the importance of CSA-131 for treating serious or life-threatening infections. The QIDP designation grants five years of additional market exclusivity and the potential for fast-track designation. allows us to work even closer with the FDA to bring patients a new treatment faster.”

The QIDP designation is part of the GAIN Act which was enacted to spur antibiotic drug development. It provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA’s Fast Track Designation, and a five-year regulatory exclusivity extension.

About CSA-131 and medical device applications.
CSA-131 is a member of the class of Ceragenin compounds invented by Professor Paul B. Savage, the Reed M. Izatt Professor of Chemistry and Biochemistry at Brigham Young University (BYU, Provo, Utah). CSAs are a platform technology with wide application. Since 2019, Ceragenins have been the subject of overt 100 peer reviewed journal articles of which 50 relate to Cystic Fibrosis. Research has shown that CSA-131 is active against all ESKAPE pathogens as well as COVID-19 and the fungal pathogens Candida auris and Aspergillus. A publicly available selection of peer reviewed journal articles is available at www.n8medical.com/publications.

About our Medical Device Platform to Prevent HAIs.

Aside from the use of CSA-131 as an inhaled drug for CF patients, N8 Medical has also developed a CSA-131 coated endotracheal tube designed to prevent Ventilator Associated Pneumonia (VAP) in mechanically ventilated ICU patients. FDA has designated the CeraShield Endotracheal Tube as a “breakthrough device” pursuant to the 21st Century Cures Act. That device is now approved for routine clinical use in Canada, Brazil and Colombia and other ex-US countries. A large clinical study — the CEASE-VAP study – is currently underway at Kingston General Hospital in Kingston, Ontario led by Professor John Muscedere to evaluate the comparative efficacy of the CeraShield ETT vs. an uncoated ETT with subglottic suctioning feature in preventing VAP. Over 125 patients have been enrolled with a target enrollment of 400 patients. Biofilm fouling of endotracheal tubes has been identified as the causative agent of VAP. Another clinical study is underway at Prime Hospital in the UAE with additional studies planned in Saudi Arabia, Panama and Colombia. As with CF, Pseudomonas aeruginosa is also a leading lethal pathogen in VAP. CDC estimates that 65% of all hospital acquired infections are caused by biofilm fouling of indwelling medical devices. NIH estimates that hospital acquired infections add over 30 dollars annually to the US healthcare expenditures. One of the notable features of CSA-131 is its ability to prevent and eradicate bacterial and fungal biofilms at clinically relevant concentrations.

N8 Medical has also received 3 SBIR grants (two Phase 1 and one Phase 2) to support the development of CSA-131 coated hemodialysis catheters, pedicle screws and pacemaker envelopes to reduce the incidence of hospital acquired infections. “We believe that our Ceragenin technology has the potential to transform the practice of medicine in multiple verticals and we look forward to the day when this technology is widely adopted to save many lives and avoid the billions of dollars in annual costs of bacterial and fungal infections” said Robert D. Mitchell, CEO of N8 Medical, Inc., Kinnear Pharmaceutical’s parent company.

For more information see www.N8medical.com www.Kinnearpharma.com

Contact: Carl Genberg, CEO Kinnear Pharmaceutticals
carlgenberg@kinnearpharma.com
(702) 285-5740 (PDT)

Carl Genberg
Kinnear Pharmaceuticals
+1 702-285-5740
carlgenberg@kinnearpharma.com
Visit us on social media:
LinkedIn