Shionogi's Strategies for Addressing Antibiotic Efficacy and Resistance

At IDWeek, Christine Slover, PharmD, executive medical Director for anti-infectives at Shionogi Inc, discussed leveraging real-world evidence and surveillance data to understand antibiotic efficacy in diverse patient populations. She highlighted a global registry with over 1,000 patients showing clinical response to cefiderocol in difficult-to-treat infections. Surveillance data indicated cefiderocol's effectiveness against multi-drug resistant bacteria like Pseudomonas and Enterobacteriaceae. Slover emphasized the complexity of treating patients with multiple comorbidities and the need for timely, effective antibiotics. She noted the challenges in antimicrobial research and development (R&D) investment and advocated for innovative approaches, including biologics and advanced diagnostics, to combat antimicrobial resistance.

“Real-world evidence data is great because one of the things that it allows us to do is really understand difficult-to-treat infections, different patient populations, things that you don't necessarily capture in randomized, controlled trials,” Slover explained. She emphasized that while real-world evidence is not intended to replace clinical trial data, it provides a deeper understanding of how to use antibiotics effectively.

The global registry, which has been running for several years, revealed that a majority of patients responded positively to cefiderocol. Slover defined clinical response as the “resolution or improvement in the signs and symptoms of the infection, as determined by the treating physician at the end of therapy.”

In addition to real-world data, Shionogi has been actively conducting surveillance studies. “We’ve shown that cefiderocol maintains its activity even in isolates that have cross-resistance to contemporary beta-lactams,” she noted. This includes its efficacy against highly resistant bacteria, particularly those harboring metallo-beta-lactamase genes.

The complexity of treating patients with multiple comorbidities poses significant challenges. “Patients who get these highly resistant infections are usually incredibly complex. They have lots of comorbidities,” Slover stated. “Understanding your patient and their history, as well as your local susceptibility patterns, is crucial. You need to identify an antibiotic that not only can treat the patient but can also effectively target the resistant organism.”

Slover discussed timely intervention, noting, “every hour you delay in getting that right antibiotic on board can impact the outcomes in that patient.” This highlights the critical need for clinicians to synthesize extensive information to select the appropriate treatment.

Looking ahead, Slover discussed the ongoing struggle with antimicrobial R&D investment. “Despite the WHO's annual publication of the top 24 resistant pathogens of concern globally, companies are still pulling back on investment in this space, which is detrimental,” she said. “One of the things I love about working for Shionogi is we're incredibly committed to this area. We’ve recently acquired Qpex Biopharma to expand our R&D capabilities in the US and globally.”

Slover also called for innovative approaches in antimicrobial development. “We need to start thinking outside of the box. Instead of developing small molecules, we should explore biologics, microbiome modulators, and monoclonal antibodies,” she said. Such advancements could complement existing antibiotics or offer alternative treatment options.

Furthermore, Slover highlighted the importance of modernizing diagnostic technologies, noting, “we're still using some technology that's 80 years old,” which can delay critical susceptibility results. Rapid diagnostic advancements, including Shionogi’s recent agreement with Next Gen Diagnostics for sequence-based susceptibility testing, are vital for improving patient care. As the fight against antimicrobial resistance continues, Shionogi's focus is on real-world evidence and new solutions, addresses this global health challenge.