Adjutec applies for phase I start
Norwegian AdjuTec Pharma prepares for clinical trials with its concept for battling antimicrobial resistance. The company recently raised 16 MNOK and sent a clinical trial application to the swedish regulatory autorities, aming to start phase I this summer. BioStock contacted CEO Bjørn Klem to get an update.
AdjuTec Pharma is at the forefront of addressing the issue of antimicrobial resistance (AMR). The company’s lead compound, APC148, is aimed at inhibiting the activity of metallo-β-lactamases (MBL), a key bacterial defense against antibiotics. When combining APC148 with a serine-β-lactamase (SBL) inhibitor and the antibiotic meropenem, the company has shown encouraging results in both MBL and SBL-producing bacteria strains. This combination product (APC301) will become the most active antibiotic towards multidrug resistant bacteria in the market today. Adjutec has completed extensive preclinical safety studies with APC148, preparing the company for starting the clinical phase I program.
CTA submitted
The next step is to conduct clinical phase studies, first with APC148 alone and later with the triple combination. Adjutec recently sent in a clinical trial application to the Swedish Medical Products Agency, hoping to start phase I trials with the candidate during the second quarter.
The study is to be conducted at the Clinical Trial Consultants clinic in Uppsala and will provide important data on the pharmacokinetics and safety of the substance after intravenous administration of ascending doses of APC148.
“We are currently designing the entire phase I program, with the goal of making it as efficient as possible. Since we need to test both APC148 alone and APC301, we are looking at a relatively large phase I programme in 100 – 150 healthy subjects. Both APC148 and APC301 needs to be tested in single- and multiple dose study designs to decide on a recommended dose before moving to phase II studies with patients”, says Adjutec CEO Bjørn Klem.
Manufacturing for first phase I study on track
Preparing for the phase I study with APC148, the company is collaborating with Malmö-based Rechon Life Science and German CPL Sachse on the GMP manufacturing of drug product and the substance. Work is progressing as expected for delivery before summer.
”It has been a pleasure to work with regional suppliers of drug substance and product. These are competent companies that can scale up production to our needs through the entire clinical program including a market launch”, comments Klem.
Preparing for next step in the phase I programme
At the same time, Adjutec is working on non-clinical activities, preparing for the next clinical study with APC301, the triple combination. This work includes formulation of drug products, further testing in multidrug resistant bacteria and safety studies.
“There is a lot of work preparing for the next phase I studies in 2025. But we have excellent collaborations with long-term partners at RISE Södertälje, Statens Serum Institute Copenhagen and Aptuit Verona. Actually, a lot of the guys at RISE were part of the team developing antibiotics at AstraZeneca back in the days, so they know some of these products quite well”, comments Klem.
Financing for 2024 secured
Clinical development of new drugs is a costly business, and the capital markets have been slow for drug development companies for a while now. Nonetheless, Adjutec was recently able to raise 16 MNOK. Combined with grants from the Norwegian research council and Eurostars totalling 30 MNOK, the new capital injection secures the funding for the activities in 2024.
“We will be looking for an additional capital injection later this year, to fund the second leg of our phase I programme. We hope that the capital markets will warm up a bit going forward, but you never know. So far, we have mainly raised funds from family offices, and now we will focus more on institutional investors. Good safety and efficacy data will be very important to de-risk the project in order to attract institutional players,” says Klem. “We are already in contact with a few institutions, and they are eager to see clinical safety data by end of this year.”
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