How can pharma companies advance promising antimicrobials against drug resistance?

The battle against superbugs remains a significant global challenge, as highlighted in a recent report. The lack of effective antibiotics and antifungals to combat antimicrobial resistance (AMR) poses a severe threat to global health. This crisis puts numerous lives at risk, but strategic changes in research and development (R&D) and investment in access and stewardship planning could dramatically influence the fight against AMR.

With many large pharmaceutical companies retreating from antimicrobial R&D, the pipeline for new treatments has dwindled, leaving a critical gap in the market. Nevertheless, a few advanced clinical projects show promise for addressing this crisis.

Promising Developments in Antimicrobial Treatments

Amidst the alarming scenario, several late-stage clinical projects are being closely monitored for their potential to combat resistant infections. Among these are five promising drugs:

1. GSK’s Gepotidacin: This small molecule is leading phase 3 trials focused on treating urinary tract infections. Its progress is significant in addressing bacterial resistance.

2. F2G’s Olorofim: This novel orotomide antifungal is in development for treating invasive and rare fungal mold infections, offering hope for infections that are typically hard to manage.

3. Innoviva’s Zoliflodacin: One of the most promising treatments for gonorrhoea, currently in phase 3 trials. Studies indicate minimal resistance in current strains, and in-vitro experiments have shown it is hard to induce resistance, which is a positive sign.

4. Venatorx’s Cefepime-Taniborbactam: This beta-lactam/beta-lactamase inhibitor combination is being developed for complicated urinary tract infections and hospital-acquired bacterial pneumonia.

5. Pfizer’s Aztreonam-Avibactam (Emblaveo): Recently approved in the European Union, this β-lactam/β-lactamase inhibitor combination is effective against serious infections caused by multidrug-resistant gram-negative bacteria, including those producing metallo-β-lactamase.

Impact on Global Health

These developments could potentially save at least 160,000 lives annually by providing new treatments for drug-resistant infections such as gonorrhoea, urinary tract infections, intra-abdominal infections, respiratory infections, and invasive fungal infections. The diseases addressed by these treatments disproportionately affect women and children, particularly in low- and middle-income countries (LMICs).

Jayasree Iyer, CEO of the Access to Medicine Foundation, emphasizes the critical nature of these efforts: “We have a small, but effective, arsenal in the race to combat drug-resistant infections. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance.”

Strategic Focus and Future Directions

The foundation reports that while companies are employing various strategies in their access and stewardship plans, comprehensive advance planning needs to become the norm. Encouragingly, companies like GSK, Pfizer, Innoviva, and Venatorx are initiating clinical trials that include children, aiming to bridge the gap between adult and pediatric access to these vital medicines.

Commitments for drug registration have been identified in five LMICs: China, India, Mexico, South Africa, and Thailand. However, it remains uncertain whether these treatments will be available in 108 of the 113 LMICs initially upon approval, despite the high burden of diseases in these regions.

Global Health and Policy Recommendations

Marijn Verhoef, director of operations and research at the Access to Medicine Foundation, underscores the complexity of tackling drug resistance: “This includes providing appropriate access and implementing stewardship measures to safeguard the effectiveness of innovative antimicrobials. Failure to do this will limit efforts to tackle drug resistance.”

As global health stakeholders prepare for the 2024 UN General Assembly's High-level Meeting on AMR, this report underscores the urgent gaps that need addressing. The foundation provides actionable recommendations for companies and global stakeholders to promote widespread adoption of advanced access and stewardship planning, essential for combating this pressing global health issue.

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