PHILADELPHIA–(DWPR)–Kaizen Bioscience, Co. (‘Kaizen’), a biopharmaceutical company focused on developing & commercializing assets within Infectious Diseases, is pleased to announce plans for its first NDA submission in 1H 2025. The company also congratulates Ryota Tanaka for receiving the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) 2024 BEST TDM Poster Award for the presentation of PK/PD modeling of amoxicillin/clavulanic acid in vitro effects on bacterial growth and killing and in vivo exposure evaluation in young pediatric patients.
“On behalf of Kaizen Bioscience, we would like to thank Ryota Tanaka, Sander Vinks, Tomoyuki Mizuno, NDA Partners, and the team at Cincinnati Children’s Hospital Medical Center for their support in developing this innovative model, which anchored the model-informed development of Kaizen’s PK trial and confidence in our lead program,” said Keith Dewedoff, Co-Founder & Executive Chair of Kaizen Bioscience.
The model demonstrates that a lower dose of clavulanate could provide effective drug exposure in middle ear fluid while mitigating the risk of adverse events commonly associated with the current amoxicillin/clavulanate formulations, without compromising clinical efficacy.
Kaizen aims to use this PK/PD modeling and simulation data, along with results from its pharmacokinetic trial, to support its NDA application for a novel formulation of amoxicillin and reduced clavulanate to treat children 3 months and older with bacterial infections.
For more details, reference:
1. Hoberman A, et al., “Reduced-concentration clavulanate for young children with acute otitis media,” Antimicrob Agents Chemother, 2017. DOI: 10.1128/AAC.00238-17.
2. Dagan R, et al., “Bacteriologic and clinical efficacy of high-dose amoxicillin/clavulanate in children with acute otitis media,” Pediatr Infect Dis J, 2001. DOI: 10.1097/00006454-200109000-00002.
Contacts
Keith Dewedoff
[email protected]