Adjutec is set to start its phase I clinical trial for the enzyme inhibitor APC148, marking a significant milestone for the company. The trial begins September 18 with CTC in Uppsala and will focus on assessing the candidate’s safety. With this step, AdjuTec moves from years of preclinical research into clinical-stage development, targeting the global issue of antibiotic resistance.

AdjuTec Pharma is a Norwegian biotech company focused on developing novel treatments for antibiotic-resistant infections. The leading candidate, APC148, is designed to combat bacterial resistance by inhibiting the metallo-β-lactamase (MBL) enzymes – one of two essential tools bacteria use to protect themselves from antibiotics. The other tool, serine-β-lactamases (SBL), is already handled by several existing drugs, while the MBL enzymes remain a problem.

For the last few years, Adjutec has gathered preclinical data to support APC148’s efficacy, safety, and scaled-up manufacturing. Following regulatory approval from the Swedish Medical Products Agency (MPA), Adjutec is moving forward with the phase I program, advancing the product toward the market.

– For three years, Adjutec has worked hard to advance preclinical activities to become a clinical-stage company. With the approval from the MPA and the recent release of the APC148 drug product, we’re excited to start the first administration of APC148 to humans on September 18, says CEO Bjørn Klem.

Expect results in early 2025

The study will be conducted by the clinical trial organization Clinical Trial Consultants (CTC) in Uppsala. The trial is designed as a first-in-human, single-ascending dose (SAD) trial to evaluate the safety of APC148 in healthy adult volunteers. The trial consists of 5 to 6 predefined dose groups, with two participants receiving a placebo and six receiving the active drug in each group.

The drug is administered intravenously over three hours, and each dose escalation will be carefully reviewed to ensure participant safety. Adjutec expects the study to be completed by the first quarter of 2025, after which the company plans to move on to a multiple-ascending dose (MAD) study with repeated dosing over several days.

Good results make for a robust package

The trial’s primary objective is to assess safety by monitoring vital signs and conducting regular blood sampling. The study will generate important pharmacokinetic (PK) data, helping to determine how the drug is processed in the body. This data will be crucial for identifying the optimal APC148 dose for the MAD study, administered thrice over a week or more.

Adjutec is confident that the results from this phase I trial will form a solid foundation for future clinical work and licensing negotiations.

– Success in the phase I trials will not only advance APC148 but also strengthen Adjutec’s position in licensing discussions with other pharmaceutical companies. Combining APC148 with SBL inhibitors and antibiotics (APC301) has already shown promising efficacy in pre-clinical studies, and we believe we will have a solid package to bring to the table in future partnering discussions, says Bjørn Klem.

Working with APC301 in parallel

APC301 is a combination therapy that includes APC148, the antibiotic meropenem, and an SBL inhibitor. The product is designed to offer the medical community a broad-spectrum enzyme inhibitor product to tackle antibiotic resistance caused by multiple bacteria enzymes. APC301 includes both MBL- and SBL inhibitors to counteract bacteria resistant to beta-lactam antibiotics. The triple combination APC301 is set to undergo similar SAD and MAD trials, with the outcome to define the clinical dose to be used in phase II and III clinical programs in patients.

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