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AdjuTec advances toward phase I with regulatory green light

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AdjuTec advances toward phase I with regulatory green light

27 maj, 2024

Preparing to hit the clinical stage with its antibiotic resistance breakers, Norwegian AdjuTec Pharma recently got a goahead from the Swedish Medical Products Agency. The company now hopes to begin single ascending dose studies after the summer break.

– The team has done a great job in preparing the clinical trial application. We have had a good dialogue with the Swedish authorities and the process has been really smooth, CEO Bjørn Klem tells BioStock.

AdjuTec Pharma´s development revolves around the issue of antimicrobial resistance (AMR). This resistance stems from bacteria using enzymes like metallo-β-lactamases (MBL) and serine-β-lactamase (SBL) to protect themselves from antibiotics. With the lead project APC148, AdjuTec is developing a selective MBL inhibitor and the end goal is to create a combination product (APC301) with APC148, the antibiotic meropenem and an SBL inhibitor.

– Antimicrobial resistance is on the rise, so it´s a race against time to find new products to help us in the fight against new strains of resistant bacteria, says AdjuTec CEO Bjørn Klem. Specifically, there is an ever-growing need for new types of combination treatments.

The ability to inhibit MBLs would mark a significant stride in the AMR treatment landscape, as a specific inhibition of these enzymes is currently not possible.

– The spread of MBL- and SBL-producing bacteria is widening; on top of that, some bacteria have also gained the ability to produce both MBLs and SBLs at the same time.

Regulatory green light for phase I

With the recent go-ahead from the Swedish Medical Products Agency, AdjuTec is currently preparing to move into clinical phase I studies with APC148, hoping to start trials after the summer break.

– I´m very pleased to get a green light for the start of our phase I study already now. It´s been a quick process, which shows that we have been well prepared and had a good dialogue with the authorities.

The phase I study will evaluate the tolerability and safety of APC148. The company is estimating that approximately 40 healthy volunteers need to be enrolled for the single ascending dose (SAD) part of the study. At the same time, non-clinical development is on-going to prepare for starting up a APC301 SAD study quickly after completion of the APC148 SAD study.

– We´re aiming to optimise the clinical development as much as possible. After completing the SAD stage with APC148 and APC301, we will prepare both APC148 and APC301 for the multiple ascending dose (MAD) stage.

Looking for more funding

In terms of financing, AdjuTec recently raised NOK 16 million and together with Norwegian and European non-dilutive funding, the company secured funding into first quarter 2025. With that, the company is able to get APC148 through the SAD stage, but for the other parts of the phase I programme, more funding is needed.

– This is something we are working with actively already now. We will increase those efforts during the fall, aiming to do a new capital raise early next year, says Bjørn Klem.

Ongoing strategy work

One key ingredient going into the upcoming capital raise will be the positioning of the final product. The AdjuTec board is currently working on that strategy, to create the most value going forward.

– APC301 is designed as a broad-spectrum drug, that can target both MBL- and SBL-producing bacteria. One option would be to aim for the entire addressable market. That way we target a large population, but it would also mean that we fight all other market participants. Targeting markets with a high prevalence of MBL-producing bacteria e.g. in Asia is also interesting as there are very limited treatment options with these infections.

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