Despite heightened awareness and stricter antibiotic stewardship, treatment options against antimicrobial resistance (AMR) are rapidly diminishing as pathogens evolve faster than new antibiotics can be developed. Global crises, including conflicts and pandemics, are accelerating this challenge. During the COVID-19 pandemic, up to 80 percent of hospitalized patients received prophylactic antibiotics, contributing to a 15 percent surge in resistance in the U.S. in 2021 alone, according to U.S. Centers for Disease Control and Prevention (CDC) data.
In war-torn regions, the situation is even more dire. A 2023 study in The Lancet Infectious Diseases analysed infections among Ukrainian war victims, finding that 58 percent of bacterial isolates were resistant to the last-resort antibiotic meropenem, and 49 percent of 107 strains were resistant to cefiderocol. Most alarmingly, 6 percent of Klebsiella isolates were resistant to all tested antimicrobials. The collapse of healthcare infrastructure, diagnostic limitations, and inadequate infection control amplify resistance in conflict zones. With global travel and climate-driven migration on the rise, resistant pathogens are now also spreading across borders at an unprecedented rate.
AMR is increasing significantly in Europe
The situation is also deteriorating in Europe. According to the European Centre for Disease Prevention and Control (ECDC), resistance to last-line antibiotics, such as carbapenems, continues to spread among pathogens like E. coli and Klebsiella pneumoniae. These bacteria now pose a high-to-critical risk of further spread across the EU/EEA.
Even in Norway, historically a low-AMR country, the number of patients infected with multidrug-resistant pathogens has quadrupled over the last four years, as reported by the Norwegian Institute of Public Health in April 2025. This surge not only threatens individual patients but also undermines the entire arsenal of modern antibiotics.
A new frontier in antibiotic rescue therapy
In response to this growing threat, AdjuTec Pharma is developing APC301 – a triple-combination therapy designed to combat even pan-resistant Gram-negative bacteria. APC301 combines three components: the company’s metallo-β-lactamase (MBL) inhibitor APC148, a β-lactam antibiotic, and a second β-lactamase inhibitor. This synergistic approach neutralizes key resistance mechanisms by blocking enzymes that degrade antibiotics.
Preclinical data from a global collection of MBL-producing Klebsiella and E. coli isolates demonstrate that APC301 significantly outperforms currently available alternatives in restoring antibiotic efficacy. Notably, the 25% of Klebsiella isolates from Ukrainian war victims that were pan-resistant could potentially have been treated with APC301, based on preclinical comparisons.
From phase I to regulatory momentum
AdjuTec Pharma launched its first-in-human clinical trial of APC148 in 2024. The single ascending dose (SAD) phase I study in healthy volunteers evaluates safety, tolerability, and pharmacokinetics. According to Chief Regulatory and Clinical Officer Bjørg Bolstad, the candidate has shown excellent tolerability across all dose levels tested so far. The results will shape the next phase of APC301’s development.
Meanwhile, AdjuTec Pharma has proactively engaged with the FDA and EMA to streamline the regulatory pathway. The FDA’s Qualified Infectious Disease Product (QIDP) designation for APC148 grants priority review, fast-track status, and rolling review, accelerating the path to market.
Q&A with Jethro Holter, CEO of AdjuTec Pharma
To discuss AdjuTec Pharma’s approach to tackling AMR, we spoke with CEO Jethro Holter and his team to learn about his perspective on APC301’s potential, the critical gaps in AMR treatment, and the company’s vision for advancing antibiotic therapy.
What parallels do you see between APC301’s mechanism for targeting metallo-β-lactamases (MBLs) and the multidrug resistance profiles of bacteria?
— We see that multidrug resistance caused by beta-lactamases increasingly include MBLs. There are very limited therapeutic options available for treating these infections that have alarmingly high mortality rates.
How does the triple-combination therapy APC301 work to restore antibiotic efficacy?
— The bacteria produce enzymes that destroy antibiotics. When antibiotics are combined with products that inhibits these enzymes, the antibiotic is protected and can continue fighting the bacteria.
How could APC301 have impacted patient outcomes in war-torn Ukraine?
— War victims from Ukraine are often exposed to multidrug resistant bacteria, including MBLs and SBLs. With very few options available to treat MBL-producing bacteria, APC301 would have been a perfect drug to offer these patients.
What are the most urgent gaps in AMR treatment today?
— AMR challenges differ with respect to world regions and the quality of health care services. Countries with strict use of antibiotics, including the Nordic countries, are doing far better compared to countries in south-east Europe and many low-middle-income countries. The treatment gap of AMR today is caused by lack of therapeutic alternatives to meet MBL-producing bacteria. In addition, we see an increase in bacteria that fight antibiotics through multiple mechanism-of-actions, including Acinetobacter and Pseudomonas.
What preliminary insights have emerged from the APC148 phase I study?
— The phase 1 study showed us that APC148 is well tolerated at anticipated therapeutic doses. Secondly, blood analyses showed us that the substance has distribution and elimination properties that comply well with the proposed antibiotics and enzyme inhibitors to be combined with APC148.
How important is FDA’s QIDP designation for AdjuTec’s strategy?
— The QIDP designation is an important signal from the FDA that our product has priority in serving a significant unmet medical need. This will give us access to scientific meetings when needed and accelerated review time for an approval in the USA.
What role could your technology play in future pandemic preparedness?
As pandemics result in increased use of antibiotics that accelerate AMR, APC301 will offer excellent treatment to patients with multidrug resistant infections, reducing the number of deaths.
How is AdjuTec Pharma preparing for larger trials with APC301?
— After completing the phase 1 program in healthy volunteers, we will run a phase 2 and 3 clinical program in patients, most likely in collaboration with international partners. We are now preparing the study designs to be discussed with US and European medicinal authorities to secure optimal clinical development program.
What type of partnerships are you actively pursuing?
— AdjuTec Pharma seeks both investors to finance the clinical program, as well as international partners that can support the late-stage clinical program but also commercialize and distribute APC301 in global markets. We are already in discussions with international companies in emerging markets that take interest in developing APC301 to their own territories. Furthermore, we are strategically partnering in research collaborations with other pharmaceutical companies such as Venus Remedies in India (read more here.)
Where do you see AdjuTec five years from now?
— We very strongly believe that an MBL-inhibitor technology will be integrated within the products becoming available for treatment of these infections in the years to come. AdjuTec Pharma’s technology is well positioned to take the lead together with its partners in bringing to market the world’s most effective broad-spectrum antibiotic.
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