PARK CITY , UTAH , UNITED STATES , January 17, 2023 /EINPresswire.com/ -- Kinnear Pharmaceuticals, LLC, a subsidiary of N8 Medical, Inc., aka N8 Biosciences (the "Company" or "Kinnear”), is pleased to announce that it filed a pre- Investigational New Drug ("IND") meeting request letter with the U.S. Food and Drug Administration ("FDA") to discuss the drug development plan for its inhaled drug to treat cystic fibrosis patients.

"We are excited to take this important first regulatory step with the FDA for the development of our CSA-based drug for cystic fibrosis " said Carl Genberg, Kinnear’s CEO. "This helps to define the critical path for clinical development and marketing approval of our new cystic fibrosis therapeutic."

About CSA for Cystic Fibrosis

Patients with cystic fibrosis have an impaired innate immune response which deactivates the body’s natural ability to prevent respiratory infections. The key component of the lung’s ability to prevent respiratory infections is a long chain peptide known as LL-37. There are now 40 peer reviewed journal articles that discuss the important role that LL-37 plays in cystic fibrosis. https://pubmed.ncbi.nlm.nih.gov/?term=LL-37+cystic

The unique milieu of the CF lung combines highly viscous mucous and high salt concentrations which together greatly diminish the protective function of LL-37. Kinnear’s CSA drug is a synthetic small molecule non-peptide functional biosimilar to LL-37 which, unlike LL-37, can retain its antimicrobial and antifungal efficacy even in the presence of CF mucous https://pubmed.ncbi.nlm.nih.gov/17584802/

Low levels of CSA are able to prevent biofilm formation by Pseudomonas and high levels are able to eradicate the biofilm. Pseudomonas aeruginosa is a leading CF pathogen. Biofilms are slime-like aggregations of millions of colony

forming units (CFUs) that are highly resistant to conventional antibiotic therapies. The CF Therapeutics Foundation has highlighted the need to develop new therapies to treat CF respiratory infections. The global cystic fibrosis market size stood at USD 5.12 billion in 2019 and is projected to reach USD 31.88 billion by 2027. Kinnear’s research and development is supported by a $3 million grant from the CF Therapeutics Foundation.

About Kinnear Pharmaceuticals, LLC

Kinnear Pharmaceuticals is a subsidiary of N8 Medical, Inc., aka N8 Biosciences. Kinnear is focused on the use of CSA compounds licensed from BYU for use in therapeutics addressing diseases of the oral, lung and gut microbiomes, including CF, IBD, UC, Alzheimer’s disease, Periodontal disease and Kostmann’s syndrome. Kinnear is actively seeking strategic partners.

For more information please contact:

Carl Genberg
N8 Biosciences
+1 702-285-5740
CarlGenberg@N8Medical.com

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