PHILADELPHIA, PA — Kaizen Biosciences, Co., a Philadelphia-based biopharmaceutical firm, is making strides toward regulatory approval for its novel pediatric antibiotic formulation, following the acceptance of new research for presentation at IDWeek 2025 and the release of promising pharmacokinetic data at a recent global scientific forum.
The company’s abstract will be featured at IDWeek, a leading infectious disease conference, highlighting Kaizen’s continued push to improve care for young children facing bacterial infections. The spotlight is on a reduced-clavulanate formulation of amoxicillin designed specifically for infants and toddlers between 3 and 24 months of age.
Earlier this year, Kaizen presented comparative pharmacokinetic data at the International Society of Pharmacometrics (ISoP/ISOM) conference. The findings, delivered by Dr. Carl Peck—former Director of the FDA’s Center for Drug Evaluation and Research—showed that standard pediatric Augmentin ES-600 results in clavulanic acid exposures that surpass adult formulations, potentially raising concerns over optimal dosing for young children. Kaizen’s investigational formula, containing a lower amount of clavulanate, was found to maintain effective antibacterial activity against Haemophilus influenzae strains without the excess exposure.
The company is preparing to submit a New Drug Application (NDA) for the new formulation in September 2025. In parallel, Kaizen plans to apply for consideration under the FDA’s recently announced Commissioner’s National Priority Voucher (CNPV) Program. The program is intended to expedite the review of medicines that meet urgent public health needs while promoting domestic pharmaceutical manufacturing.
Keith-Harrison Dewedoff, Co-Founder and Executive Chair, emphasized the broader significance of the company’s mission. “We’re excited to share this important data with the medical and regulatory communities and we remain committed to pursuing our company philosophy of ‘Change, For the Better,’” he said. “The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA’s new CNPV program, underscores the significance and urgency of our approach.”
With antibiotic resistance and pediatric dosing optimization among the industry’s ongoing challenges, Kaizen’s formulation could mark a meaningful advancement in the treatment of bacterial infections in the most vulnerable age group.
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