AdjuTec Pharma enters phase I with novel AMR treatment
AdjuTec Pharma has launched a phase I clinical trial for its leading candidate, APC148, targeting a critical unmet need in combating antimicrobial resistance. This move into human trials is a significant milestone in demonstrating the safety and therapeutic potential of APC148, positioning AdjuTec as a key player in the fight against high-priority drug-resistant infections. CEO Bjørn Klem comments on the company’s strategy going forward.
Founded in 2019 and originating from research at the University of Oslo, AdjuTec Pharma focuses on creating novel β-lactamase inhibitors that restore the effectiveness of antibiotics against multidrug-resistant bacteria. The company’s lead candidate, APC148, targets Metallo-β-lactamases (MBLs), a group of enzymes some bacteria use as a defense mechanism to render many last-resort antibiotics ineffective.
The World Health Organization (WHO) has highlighted MBL-producing bacteria as one of the most pressing issues within antimicrobial resistance (AMR) today. In its recently updated Bacterial Priority Pathogens List for 2024, WHO categorized these pathogens as critical, emphasizing the urgent need for new treatments.
With more than 1 million people succumbing to antibiotic-resistant infections every year, The Lancet estimates that AMR-associated deaths could accumulate to 39 million by 2050. The worrying development hasn’t gone unnoticed, with the UN General Assembly recently arranging a High-Level Meeting on the topic.
Phase I trial design and objectives
Taking on this high-priority challenge, AdjuTec has presented promising preclinical data showing that APC148 is highly effective against several multidrug-resistant bacteria strains. Recently, the company initiated the single-ascending dose (SAD) part of its phase I trial, designed to evaluate the candidate’s safety and tolerability in healthy volunteers.
The study is conducted by Clinical Trial Consultants (CTC) in Uppsala, Sweden. It consists of 6 predefined dose groups, with participants receiving APC148 or placebo intravenously over three hours. The data will be used to identify a safe and anticipated effective dose for the subsequent multiple-ascending dose (MAD) part of the study.
The primary objective of the phase I trial is to establish APC148’s safety profile, while secondary objectives include pharmacokinetic assessments to understand how the drug behaves in the human body.
Looking for continued funding
The launch of the phase I study follows a recent NOK 16 million financing round, supporting preparations for the next phase I studies in 2025. AdjuTec is actively engaging in discussions with investors to secure additional funding to continue the phase I and II clinical programs.
With results from the first clinical study of APC148 expected in early 2025, AdjuTec aims to advance the development of the final combination product (APC301). APC301 combines APC148 with an antibiotic and another enzyme inhibitor to create a broad-spectrum enzyme-inhibitor product.
– The financing of our first phase I study is secured. In the next round, we want to raise capital for the phase I and II APC301 program, which will run from 2025 to 2027. Our preferred partners are venture capitalists who can help us reach the import value inflection point after phase II. At the same time, we are actively applying for non-dilutive funding, AdjuTec CEO Bjørn Klem tells BioStock.
Advances combination product
In addition, AdjuTec is looking to raise grant money for a project aimed at creating yet another combination product.
– APC301 targets Enterobacterales, including E. coli and Klebsiella bacteria, which are the biggest killers. We are now encouraged to develop a product that targets Acinetobacter, a bacterium that is not as common as the others but has shown the highest level of resistance to modern antibiotics.
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