– Our lead product APC301 has shown excellent preclinical efficacy in a group of bacteria called Enterobacterales that are the main cause of cUTI infections. These patients are the most common, with the highest mortality worldwide and represent a highly attractive commercial opportunity, says Jethro Holter and Bjorn Klem.
Antimicrobial resistance (AMR) is one of the greatest health threats of our time, with the World Health Organization warning of 39 million potential deaths by 2050 if new treatments are not introduced to the market.
AdjuTec Pharma's is positioning itself at the forefront of the fight against AMR with its lead program, APC301, a combination product including the company's metallo-β-lactamase (MBL) inhibitor APC148, designed to combat even pan-resistant Gram-negative bacteria. APC301 blocks bacterial enzymes that typically degrade antibiotics, restoring the effectiveness of the antibiotic.
Preclinical studies have shown that APC301 outperforms existing alternatives in MBL-producing bacteria common in patients with complicated urinary tract infections (cUTI) that are notoriously difficult to treat. These bacteria had alarmingly high death rates during the Covid-pandemic in South-Europe and is commonly seen in East-Europe including Ukrainian war victims. APC301 could potentially have been lifesaving for many of these patients.
Putting APC148 to the test in human trials
In 2024, AdjuTec launched its first-in-human clinical trial with APC148, testing safety and pharmacokinetics (body distribution and elimination) in healthy volunteers. Early results show excellent tolerability across all dose levels, supporting the dose level believed to be effective in patients.
The company has previously secured the FDA's Qualified Infectious Disease Product (QIDP) designation for APC148, securing priority review and fast-track development. Combined with ongoing dialogue with both the FDA and EMA, AdjuTec now has a regulatory pathway that will shorten the time for APC301 to market.
Eurostars consortium: a cross-border collaboration
The Eurostars project, announced August 25, brings together leading European SMEs with complementary expertise: Vivexia (France) will perform in vivo microbiology testing; PureIMS (The Netherlands) will optimize inhalable formulations using its proprietary inhaler; duck CTC (Sweden) will conduct clinical studies to assess delivery of APC148 to the lungs of healthy volunteers.
AdjuTec will coordinate the program, conducting microbiology screening and toxicology studies. The consortium aims to identify the most effective drug combinations and dosing strategies to treat severe hospital-related lung infections caused by multidrug resistant pathogens.
- The signing of the Eurostars consortium agreement is exciting news for AdjuTec Pharma as it will expand our technology platform to a new patient population with severe lung infection, says Bjorn Klem, COO and project coordinator at AdjuTec Pharma.
– Together with our partners we will investigate new drug combinations and formulations to broaden the commercial potential of partner technologies and competencies.
Comments from the CEO and COO
To better understand the collaboration and its implications, we turned to AdjuTec Pharma's CEO, Jethro Holter and COO, Bjørn Klem
What does securing the Eurostars funding mean for AdjuTec's overall strategy?
- The Eurostars funding allows us to broaden the patient indication of APC301 that will have great impact on the commercial prospect of this product. Furthermore, it has the potential to identify other new pipeline combinations for future consideration.
Could you elaborate on the role APC148 will play in this Eurostars project?
- APC148 is the cornerstone of the project as we will test the availability of this compound to the lungs. It is important to secure the correct dosing of APC148 when starting to treat these patients.
Why was lung infection chosen as the focus for this collaboration?
- Patients with complicated lung infections is the largest population with an increasing unmet medical need, which makes it an attractive commercial opportunity. Lung infections account for a 44 per cent share of beta-lactam antibiotic treatment market (Total Addressable Market estimated to reach 29,2 Bil Euro by 2029). These patients often present with slightly different bacteria compared to patients with cUTI and we will therefore combine our APC148 technology with other antibiotics to address this challenge.
How do the consortium partners complement AdjuTec's expertise?
- AdjuTec has competence in how to develop antibiotics together with our advisors. The Eurostars consortium partners are the executors of the R&D activities as AdjuTec lacks the facilities to undertake these tasks.
What are the key milestones expected during the three-year project?
– The key milestones in the Eurostars project are to define the most effective antibiotic product based on microbiology testing in the lab, decide on the most suitable formulation of APC148 with respect to lung administration and finally test this formulation in human volunteers.
How might results from this program influence the global fight against antimicrobial resistance?
– This program addresses the huge challenge of how to treat patients with severe lung infections that are caused by several multidrug resistant bacteria. AdjuTec's lead product APC301 is effective in some of these bacteria. In this project we will address all main bacteria that contribute to these infections. The results will have a major positive impact on the treatment of these patients worldwide.
What are the commercial opportunities for APC301 beyond hospital-acquired lung infections?
– Our lead product APC301 has shown excellent preclinical efficacy in a group of bacteria called Enterobacterales that are the main cause of cUTI infections. These patients are the most common, with the highest mortality worldwide and represent a highly attractive commercial opportunity.
How important is regulatory engagement at this early stage of development?
- Close regulatory contact is key to the development of new antibiotics. This is why we stay engaged with the most relevant authorities and take advantage of their services to reduce the time to reach the market.
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