Novoclem Therapeutics announced its lead inhaled antimicrobial drug candidate, BIOC51, has been designated as a "Qualified Infectious Disease Product" (QIDP) by the U.S. Food & Drug Administration (FDA). The QIDP designation, granted for treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, will make BIOC51 eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the FDA, BIOC51 is eligible for an additional five-year extension of market exclusivity.
"We are very pleased that the FDA has granted QIDP designation to BIOC51," said Anne Whitaker, Chief Executive Officer of Novoclem Therapeutics. "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."
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. The level of NO release from BIOC51 has proved sufficient for eradicating planktonic and biofilm-based bacteria, and can be delivered to the lungs as a dry powder or solution (e.g., nebulization).
Cystic Fibrosis (CF) is a rare life-threatening hereditary disease characterized by the production of thick, hard to clear mucus within the lung, leading to recurrent lung infections and loss of lung function. Antibiotic therapy, routinely used to treat lung infections in people with CF, becomes ineffective as bacterial resistance develops. The thick mucus within the lungs also makes it difficult for antibiotics to penetrate bacterial colonies so there is a great need to develop alternative agents that can treat bacterial infection in people with CF.