Novoclem Therapeutics says that its BIOC51 inhaled antimicrobial has received Qualified Infectious Disease Product (QIDP) designation from the FDA. The company says that BIOC51 could be delivered as either a dry powder or as an inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients.
According to Novoclem, “BIOC51 is a novel polyglucosamine biopolymer covalently modified with N‑diazeniumdiolate nitric oxide (NO) donors to facilitate spontaneous (without the need of enzymes) and controlled NO release.” Submission of an IND and initiation of clinical trials for BIOC51 is expected next year.
Novoclem Therapeutics CEO Anne Whitaker commented, “We are very pleased that the FDA has granted QIDP designation to BIOC51. Chronic, persistent lung infections with Pseudomonas aeruginosa are a major factor impacting the poor quality of life and untimely death in cystic fibrosis patients. The QIDP designation will accelerate the advancement of BIOC51 development as a potential treatment for these patients.”
Formerly known as Know Bio Respiratory, Novoclem is a subsidiary of Know Bio, which is a spin off of Novan Therapeutics.
Read the Novoclem Therapeutics press release.