Print（PDF/183KB） Jun. 19, 2023 R&D
Joint Research between The Kitasato Institute and Sumitomo Pharma Data on KSP-1007/Meropenem for the Treatment of Carbapenem-Resistant Infections, Presented at the American Society for Microbiology (ASM) Microbe 2023
The Kitasato Institute (Headquarters: Minato-ku, Tokyo; President: Hirosuke Kobayashi; hereinafter “Kitasato Institute”) and Sumitomo Pharma Co., Ltd. (Head Office: Osaka; Representative Director, President and CEO: Hiroshi Nomura; hereinafter “Sumitomo Pharma”) announced today that the Phase I study (hereinafter “the study”) of KSP-1007 (developmental code), in combination with meropenem, has been conducted, demonstrating favorable pharmacokinetics without any serious adverse events. The results of the study were published at the American Society for Microbiology (June 15-19, Houston, USA, hereinafter “ASM Microbe 2023”).
- The abstract of the study results can be found at:
- https://www.abstractsonline.com/pp8/#!/10789/presentation/6827
Additionally, eight poster presentations and one oral presentation have been made with nonclinical pharmacological and pharmacokinetic data.
[Presentations at the ASM Microbe 2023]
<Oral presentation>
| Title | KSP-1007, a Broad-Spectrum Inhibitor of Serine- and Metallo-β-Lactamases for Combination with Meropenem |
|---|---|
| Section No. | Session CTS018 - New Agents (AAR) |
| Information | 4:30 PM – 5:00 PM, June 17, 2023 370 A-F-GRB Center |
<Poster presentations>
Section No.:
P007. AAR08 New Antimicrobial Agents: New Small Molecules? Beta-Lactamase Inhibitors (BLIs)
Information:
10:00 AM - 5:00 PM, June 16, 2023
Exhibit and Poster Hall (Hall BCD)
| Poster No. | Title |
|---|---|
| 519 | Safety, Tolerability, And Pharmacokinetics Of KSP-1007 After Single And Multiple Ascending Doses Alone Or In Combination With Meropenem In Healthy Subjects |
| 497 | The Broad-Spectrum β-Lactamase Inhibitor KSP-1007: Biochemical Characterization of Inhibitory Activity against Various β-Lactamases (BL)s |
| 503 | The Broad-Spectrum β-Lactamase Inhibitor KSP-1007: In Vitro Activity in Combination with Meropenem (MEM) against Gram-Negative Bacteria (GNB) Including Carbapenemase Producers |
| 500 | The Broad-Spectrum β-Lactamase Inhibitor KSP-1007: Bactericidal Activity, Effects of Human Plasma, Serum Albumin, Urine and Medium pH on the In Vitro Activity in Combination with Meropenem (MEM) against Carbapenemase-Producing Enterobacterales (CPE) |
| 505 | The Broad-Spectrum β-Lactamase Inhibitor KSP-1007: In Vivo Activity in Mouse Model of Systemic and Urinary Tract Infection (UTI) Due to Carbapenemase-Producing Gram-Negative Bacteria (CP-GNB) |
| 498 | The Broad-Spectrum β-Lactamase Inhibitor KSP-1007: In Vivo Activity against Carbapenemase-Producing Acinetobacter baumannii (CP-Ab) in a Mouse Lung Infection Model |
| 499 | The Broad-Spectrum β-Lactamase Inhibitor KSP-1007: Pharmacokinetics /pharmacodynamics in Combination with Meropenem (MEM) against Carbapenemase- Producing Klebsiella pneumoniae (CP-Kp) and Acinetobacter baumannii (CP-Ab) in a Neutropenic Murine Thigh Infection Model |
| 501 | The Broad-Spectrum β-Lactamase Inhibitor KSP-1007: Pharmacokinetics, Distribution, Metabolism, And Excretion In Nonclinical Studies |
Reference
About KSP-1007
KSP-1007 was discovered through research and development initiative selected by the Japan Agency for Medical Research and Development (AMED) for its Cyclic Innovation for Clinical Empowerment (CiCLE) program for collaboration among industry, academia, and government. Highly resistant bacteria, which are considered a global problem, produce β-lactamases, which degrades even carbapenem antibiotics. KSP-1007 can broadly and strongly inhibit the β-lactamases. In addition, KSP-1007 is expected to become an effective treatment option against carbapenem-resistant bacterial infections in combination with meropenem hydrate, a carbapenem antibiotic in general use worldwide. (The name of Sumitomo Pharma’s product for the Japanese market: MEROPEN®.)
In August 2022, KSP-1007 was approved by the U.S. Food and Drug Administration as a Qualified Infectious Diseases Product/Fast Track for the treatment of complicated urinary tract and intra-abdominal infections and hospital-acquired/ventilator-associated pneumonia. For details, please refer to the press release as of September 29, 2022 (https://www.sumitomo-pharma.com/news/assets/pdf/ene20220929.pdf).
About carbapenem-resistant bacterial infections
Carbapenem-resistant bacteria infections is a general name for infections due to bacteria, such as Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii with resistance to meropenem and other carbapenem antibiotics, which are important for the treatment of severe infections. These infections are classified as Priority 1 (Critical) in the “List of bacteria for which new antibiotics are urgently needed” published by the WHO.
About Cyclic Innovation for Clinical Empowerment (CiCLE)
CiCLE aims to formulate innovative infrastructure, including human resources, for accelerating research and development and the clinical application of drug discovery outcomes in ways that precisely match the needs of healthcare professionals as well as to create an environment that empowers the development of open innovation in medical research and development by bringing together Japan’s collective strengths through industry-academia-government collaborations. The “Drug discovery research aiming at developing agents against infections from bacteria with antimicrobial resistance (AMR)” joint initiative between Kitasato Institute and Sumitomo Pharma (Representative organization: Sumitomo Pharma) was selected as a research and development project through an open invitation in the first round of CiCLE grant programs in 2017.
About The Kitasato Institute
Kitasato Institute states its mission as: “With profound respect for the sanctity of life, our purpose is to contribute to society by dedicating ourselves to the quest for truth through the application of practical science.” The institute has a long tradition and track record in infection control research that began with Dr. Shibasaburo Kitasato, its founder, and is now being continued by Dr. Satoshi Ōmura, a recipient of the Nobel Prize in Physiology or Medicine. In fulfilling its mission of contributing to society, Kitasato Institute focuses on education, research, and medical care. For more details, please visit Kitasato Institute website(https://www.kitasato-u.ac.jp/en).
About Sumitomo Pharma Co., Ltd.
Sumitomo Pharma defines its corporate mission as: “To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives for people worldwide.” By channeling its total efforts into research and development, it aims to provide innovative and effective pharmaceutical and healthcare solutions to people not only in Japan but also worldwide in order to realize its corporate mission. For more details, please visit Sumitomo Pharma’s website(https://www.sumitomo-pharma.com).
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