Meiji Seika Pharma’s Nacubactam to Be Featured in 10 Presentations at ESCMID Global 2026 — Including Phase III Integral-2 Results

Meiji Seika Pharma Co., Ltd. (headquartered in Tokyo; President and Representative Director: Toshiaki Nagasato) today announced that at ESCMID Global 2026, to be held from 17 to 21 April 2026, it will present a total of ten studies on its novel β-lactamase inhibitor nacubactam (development code: OP0595), for which a manufacturing and marketing authorisation application is under review in Japan. The presentations include results from Integral-2, an international, multicentre Phase III clinical trial in patients with infections due to carbapenem-resistant Enterobacterales (CRE).

Currently, carbapenem-resistant bacteria pose a global threat because carbapenems are considered last-resort agents for severe infections. The development and approval of effective agents against multidrug-resistant Gram-negative bacteria, including CRE, are urgently needed (WHO Bacterial Priority Pathogens List, 2024). In December 2025, Meiji Seika Pharma submitted an application for manufacturing and marketing approval of nacubactam in Japan and remains committed to contributing to global efforts against AMR—the “silent pandemic.”

The planned presentations are as follows:

• Efficacy and safety of cefepime/nacubactam and aztreonam/nacubactam vs best available therapy in adults with cUTI/AP, HABP/VABP, cIAI due to carbapenem resistant Enterobacterales: Integral-2, single-blind, randomised phase III trial — Oral presentation (O0107); Clinical
• Outcomes of cefepime/nacubactam and aztreonam/nacubactam for treatment of cUTI/AP patients with CRE: subgroup analysis of Integral-1 study — Poster (P2876); Poster Walkthrough (R0058); Clinical
• Outcomes of cefepime/nacubactam and aztreonam/nacubactam in cUTI/AP patients with ESBL-producing bacteria enrolled into prospective phase III randomised clinical study (Integral-1) — Poster (P2864); Clinical
• Efficacy and safety of cefepime/nacubactam and aztreonam/nacubactam compared with imipenem/cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis: Integral-1, a double-blind, randomised phase III trial — Poster (P2857); Clinical
• The in vitro activity of aztreonam/nacubactam and cefepime/nacubactam against molecularly characterised Enterobacterales isolates including those with ceftazidime-avibactam and aztreonam/avibactam resistance mechanisms collected globally from 2021–2023 — Top Rated Poster (P1622); Non-clinical
• Activity of the novel combination therapy cefepime/nacubactam against 17,220 clinical isolates of Enterobacterales collected worldwide during 2021–2024 — Poster (P1197); Non-clinical
• In vitro activity of nacubactam against broad-spectrum β-lactamases — Poster (P2659); Non-clinical
• Probability of target attainment of cefepime/nacubactam and aztreonam/nacubactam for carbapenem-resistant Enterobacterales infections — Poster (P2742); PK/PD
• Population pharmacokinetic analysis of nacubactam, cefepime, and aztreonam and exposure–response analysis of efficacy results from phase III clinical trials — Poster (P2743); PK/PD
• Determination of the nonclinical PK/PD target value for nacubactam in a mouse thigh infection model using carbapenem-resistant Enterobacterales under co-administration of cefepime or aztreonam — Poster (P2744); PK/PD

Following congress selection, O0107 was chosen for an Oral Presentation, P2876 for the Poster Walkthrough session, and P1622 as a Top Rated Poster (top 2%).

About nacubactam (development code: OP0595)

Nacubactam (development code: OP0595) is a novel β-lactamase inhibitor discovered by Meiji Seika Pharma. In combination with existing β-lactam antibiotics such as cefepime or aztreonam, nacubactam is expected to be effective against carbapenem-resistant Enterobacterales (CRE), including carbapenemase-producing strains. In addition, nacubactam inhibits penicillin-binding protein 2 (PBP2), an enzyme involved in the biosynthesis of peptidoglycan in the bacterial cell wall, thereby conferring a property that distinguishes it from other β-lactamase inhibitors.

In the Integral-1 trial, for the primary endpoint of composite clinical and microbiological response at seven days after the end of treatment, superiority of cefepime/nacubactam over imipenem/cilastatin and non-inferiority of aztreonam/nacubactam to the same comparator were demonstrated. With respect to safety, no significant safety concerns were observed (press release dated 14 March 2025).

In the Integral-2 trial, for the primary endpoint of overall composite response at seven days after the end of treatment across all enrolled indications, high efficacy of both cefepime/nacubactam and aztreonam/nacubactam was confirmed compared with best available therapy. With respect to safety, no significant safety concerns were observed.

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