Late last year, AdjuTec Pharma launched a phase I clinical trial for its lead candidate, APC148, targeting antimicrobial resistance, AMR. Recently, seasoned life science executive Jethro Holter stepped into the CEO role. BioStock talked with Holter to discuss his decision to join AdjuTec Pharma, exploring his vision for the company and the role APC148 could play in tackling the global AMR challenge.

AdjuTec Pharma’s competitive edge in the AMR field stems from its specialization in developing β-lactamase inhibitors designed to restore the efficacy of antibiotics against multidrug-resistant bacteria. The company’s lead candidate, APC148, specifically targets Metallo-β-lactamases (MBLs), enzymes that enable bacteria to neutralize antibiotics and render them ineffective.

This positions AdjuTec Pharma as a noteworthy contributor with a niche focus on combating high-priority drug-resistant infections.

A growing threat

More than one million people die from AMR-associated infections annually, a number that is projected to reach 39 million by 2050 unless effective interventions are developed.

The World Health Organization has consistently flagged antimicrobial resistance AMR as a critical global health challenge, with bacteria producing Metallo-β-lactamases classified among the most urgent threats. They are particularly difficult to manage due to limited treatment options. When also factoring in the increased complexity and cost of patient care, it becomes evident that there is a pressing need for sustained investment in research and development.

Anticipating AdjuTec Pharma’s phase I results

Recognizing this urgency, AdjuTec Pharma has focused on creating solutions that can counteract the effects of drug resistance. APC148, when combined with antibiotics and other inhibitors, has shown promising preclinical efficacy against multidrug-resistant bacteria, positioning it as the new kid on the block within the AMR field.

In the latter part of 2024, AdjuTec Pharma commenced its first-in-human single-ascending dose study, which is a part of its ongoing phase I clinical trial for APC148. Conducted by Clinical Trial Consultants (CTC) in Uppsala, the study evaluates safety, tolerability, and pharmacokinetics in healthy volunteers.  The company anticipates receiving the full study results in Q2 this year.

For AdjuTec Pharma, the trial marks a major step forward in demonstrating APC148’s potential as a solution for combating AMR. With initial results anticipated early this year, the data will pave the way for developing a final combination product, APC301, which combines APC148 with an antibiotic and another enzyme inhibitor to create a broad-spectrum enzyme-inhibitor product.

“Our objective is to develop the world’s most effective broad-spectrum antibiotic combination that can be utilised globally to treat complicated hospital-acquired infections caused by multi-drug resistant and highly challenging bacteria” – Jethro Holter, CEO AdjuTec Pharma

Comments from the new CEO

As AdjuTec Pharma progresses with the development of APC148, the company has appointed experienced life science professional Jethro Holter as its new CEO. We spoke with Holter to gain his perspective on what sets their drug candidate apart in a field where many have struggled to succeed.

Could you begin by sharing an overview of your professional background?

– My professional journey began as a researcher in target discovery at Pfizer, UK. I then pursued a Ph.D. in Molecular Neuroscience from Cardiff University, UK. After returning to the industry, I joined Mole Genetics AS, Norway, as the R&D Director. Over the past two decades, I have gained extensive international experience within the life science and diagnostics industry.

– I held the position of Group CEO of ArcticZymes Technologies ASA and CEO of its subsidiaries, ArcticZymes AS and Biotec BetaGlucans AS. I also worked in international business development at Thermo Fisher Scientific. I currently hold the position of chair of the board of directors at Genetic Analysis.

Why is your background a good fit for AdjuTec?

– AdjuTec Pharma is at a pivotal moment, transitioning from research to commercialisation. My background in commercial strategy, investor relations and experience from leading Norwegian life science organisations makes me a good fit. Furthermore, I am passionate about developing and empowering talent teams that contribute to organisational growth and success.

What distinguishes APC148 from its competitors in addressing antimicrobial resistance?

– Currently, there are no commercially available examples of antibiotics combined with metallo-β-lactamase (MBL) inhibitors that are effective against MBL producing bacteria. By design, APC148 possesses a unique mechanism of action that selectively inhibits the most clinically significant MBL enzymes. Our preclinical studies show that APC148, when combined with antibiotics and other inhibitors, is more effective against multidrug-resistant MBL-producing bacteria than competitor drugs tested.

– APC148 uniquely stands out as a highly effective and versatile MBL inhibitor capable of restoring the efficacy of various beta-lactam antibiotics against MBL-producing bacteria. In simple terms, as quoted by CSO Pål Rongved, the inventor of APC148, “it is the crucial missing piece in a jigsaw puzzle”. In short, our goal is to set a new standard in antibiotic treatment.

Can you discuss the ongoing phase I trial and the next steps?

– The SAD study is still ongoing and nearing completion. In all healthy volunteers tested to date, APC148 has demonstrated excellent tolerability. The next step will be to conduct a Multiple Ascending Dose (MAD) clinical study of APC148 in healthy volunteers.

What measures are being taken to secure funding for the upcoming clinical trials?

– AdjuTec Pharma is seeking additional funding to continue its clinical trial program. Efforts are ongoing to secure new funding on two fronts. Firstly, we will build upon our previous success in securing additional non-dilutive funding through national and international grant programs. Secondly, we are currently preparing for a new fundraising round to secure private investment during mid-2025.

What are the potential advantages of developing a broad-spectrum product like APC301?

– Our objective is to develop the world’s most effective broad-spectrum antibiotic combination that can be utilised globally to treat complicated hospital-acquired infections caused by multi-drug resistant and highly challenging bacteria. APC301 will ensure that last-resort antibiotics not only retain their efficacy but also enhance their effectiveness and reliability as a treatment solution, particularly in regions where antibiotic resistance is most prevalent.

Beyond APC148 and APC301, how do you plan to expand the pipeline to combat other resistant bacteria such as acinetobacter?

– We have discovered other novel compounds that are earlier in the pipeline, such as APC247, which is effective against all important bacterial resistance enzymes. Through APC148 and our pipeline, AdjuTec Pharma intends to prioritise addressing the most critical group of bacteria defined on the World Health Organisation (WHO) Bacterial Priority Pathogens List (2024).

Finally, what developments can we expect from AdjuTec in the next six months?

– Our primary objective will be to advance the clinical program and commercialisation of APC301.

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