AdjuTec Pharm is first out in the new series “the Start-up Spotlight”, which features the most promising start-ups from the Norwegian health clusters.

The series The Start-up Spotlight and The Scale-up Spotlight are produced in collaboration between the Norwegian health clusters: Norway Health Tech, Oslo Cancer Cluster, The Norwegian Smart Care Cluster, The Life Science Cluster and Biotech North. The initiative was funded by Viken fylkeskommune.

Preparing the company’s First-in-Human phase I clinical trial

AdjuTec Pharma has developed a new antibiotic product in the fight against antimicrobial resistance (AMR), which is now ready to be tested in humans. The final product will be administered intravenously to severely ill patients infected with bacteria resistant to existing treatments.

Read more: A NLS Star 2021: A glimpse of hope in tackling antibiotic resistance

“Antimicrobial resistance is threatening modern healthcare. Physicians are running out of last-resort antibiotics for treatment of high-risk infections and as prophylaxis in for example cancer therapy and major surgical procedures,” commented Bjørn Klem, CEO of AdjuTec Pharma to Oslo Cancer Cluster.

AdjuTec Pharma has developed APC148, an enzyme inhibitor that works on gram negative bacteria. Gram negative bacteria are resistant to multiple antibiotics and listed by the World Health Organisation as the leading cause of deadly bacterial infections in the world. Bacteria defend themselves by producing enzymes that destroy antibiotics. APC148 inhibits these enzymes and thereby protects the antibiotic. This restores the activity of the antibiotic – saving patients’ lives. The technology was developed by Professor Pål Rongved’s research group at the University of Oslo. Rongved is the founder of AdjuTec Pharma and was supported by Oslo Cancer Cluster Incubator to negotiate a licensing agreement with the University of Oslo and for obtaining the initial private funding.

The first results are expected already early 2025.”

The product has already been tested and validated in animal models. Now the phase IA trial will determine how APC148 behaves in the human body (pharmacokinetics) and evaluate the safety of the compound. The trial will involve groups of healthy volunteers who will receive single escalating doses. The first results are expected already early 2025. The phase IB trial starting in 2025 will then investigate how the APC148 works in combination with a broad-spectrum antibiotic.

A unique mechanism-of-action

Bacteria produce two kinds of enzymes, serine-ß-lactamases (SBLs) and metallo-ß-lactamases (MBLs). There are SBL-inhibitor products on the market, however no MBL-inhibitor products.

“APC148 has a unique mechanism-of-action versus other MBL-inhibitor products in pipeline making this a first-in-class product candidate,” said Bjørn Klem.

AdjuTec Pharma has ambitious plans for the enzyme inhibitor, aiming to combine it with various antibiotics.

“APC148 can be combined with different broad-spectrum antibiotics, including carbapenems and cephalosporins. After intravenous administration, APC148 should preferably have comparable pharmacokinetics, meaning plasma profile, distribution and route of elimination from the human body as the antibiotic. There should be no interactions between the compounds,” explained Bjørn Klem.

Source: Sofia Lindén/Oslo Cancer Cluster

Photo of Bjørn Klem: Stig Jarnes