AdjuTec Pharma has developed a new antibiotic product (APC148) in the fight against AMR. APC148 is an enzyme inhibitor that works on gram negative bacteria. Gram negative bacteria are resistant to multiple antibiotics and listed by the World Health Organisation (WHO) as the leading cause of deadly bacterial infections in the world. Bacteria defend themselves by producing enzymes that destroy antibiotics. APC148 inhibits these enzymes and thereby protects the antibiotic. This restores the activity of the antibiotic – saving patients’ lives.

The technology was developed by Pål Rongved’s research group at the University of Oslo. Pål Rongved is professor at the Department of Pharmacy at the University of Oslo (UiO) and founder and CSO of AdjuTec Pharma. In order to attract further funding, with help from Oslo Cancer Cluster Incubator, Rongved and coworkers decided to establish AdjuTec Pharma in 2019. “It was necessary to establish a team to drive development of the company forward,” says Rongved to NLS.

New antibiotics nearly always suffer from bacteria developing resistance mechanisms for protection.

The company’s vision is to develop and provide a platform of novel antibiotic resistance breakers in order to retain efficacy and facilitate reduced use of antibiotics.

“New antibiotics nearly always suffer from bacteria developing resistance mechanisms for protection. Initial studies in meropenem resistant bacteria strains do not indicate that this is the case with the combination of APC148 and meropenem, no new resistance genes for the adjuvant was found. This possibly relates to the fact that APC148 has no effect on the bacteria themselves, only on their defence enzymes. In addition, initial efficacy and safety data, both in-vitro and in-vivo, show good efficacy on clinical resistant bacteria strains and with an excellent safety profile,” says Rongved.

Related article

#WAAW: Mini-interview SNIPR Biome

All over the Nordics the innovative power is gearing up to put new products, therapies, and preventive measures on the market that will tackle Antimicrobial resistance (AMR) from various angles. 

An urgent need

The need for new technologies to fight AMR is urgent. Resistance to carbapenem antibiotics, the last line of defense for many patients, is increasing globally.

It is alarming. This silent pandemic is estimated to take an increasing number of lives, from 700,000 today to possibly ten million deaths annually by 2050.

“It is alarming. This silent pandemic is estimated to take an increasing number of lives, from 700,000 today to possibly ten million deaths annually by 2050 according to global reports (O’Neill, 2017),” says Rongved.

The most important measure, he believes, will be to reduce misuse of antibiotics, both in agriculture and human medicine. “In addition, development and commercialization of new therapeutics needs to be incentivized to broaden the armament of society to fight bacteria resistance,” he adds.

He believes emerging adjuvant technologies, like AdjuTec’s, will become important products in combination with marketed antibiotics. “Market research shows that these technologies are more attractive to investors than traditional new antibiotics,” he says.

The global antibiotic market is estimated to reach USD 62.06 billion in 2026, with the largest market in North America but the fastest growing market in Asia Pacific.

Related article

#WAAW: New Nordic consortia in antimicrobial resistance

NordForsk has decided to fund six Nordic research networks that will apply for EU calls in the field of antimicrobial resistance (AMR).

Reduce the risk of beginner mistakes

Pål Rongved has 22 years of previous leading positions in R&D/IPR at Nycomed Imaging/GE HealthCare and as advisor in Birkeland Innovation (now Inven2) in Oslo. “As an entrepreneur, access to funding is a necessity, as well as mentorship when it comes to rigging a company and establishing a team to commercialize your lead,” he says.

It was essential to get external competence from TTO/incubators, including patenting and identifying investors, management and board, he continues. “In addition, to reduce the risk of beginner mistakes and to point out the best direction of development, early advice from key opinion leaders (KOL) is very important. Also, be sure to have negotiated an unlimited freedom to handle your IP to attract investors.”

Norway has a flourishing life science community with available public grants for projects and start-ups, according to Rongved. “During the last 30 years Norwegian investors, traditionally coming from shipping, petroleum and fish farming, have seen the opportunity in healthcare that benefits an increasing number of start-ups.”

The company’s First-in-Human phase I clinical trial

AdjuTec Pharma is now ready to test it product in humans. The final product will be administered intravenously to severely ill patients infected with bacteria resistant to existing treatments. The first results are expected already early 2025.

The phase IB trial starting in 2025 will then investigate how the APC148 works in combination with a broad-spectrum antibiotic.

The product has already been tested and validated in animal models. Now the phase IA trial will determine how APC148 behaves in the human body (pharmacokinetics) and evaluate the safety of the compound. The trial will involve groups of healthy volunteers who will receive single escalating doses. The first results are expected already early 2025. The phase IB trial starting in 2025 will then investigate how the APC148 works in combination with a broad-spectrum antibiotic.

A unique mechanism-of-action

Bacteria produce two kinds of enzymes, serine-ß-lactamases (SBLs) and metallo-ß-lactamases (MBLs). There are SBL-inhibitor products on the market, however no MBL-inhibitor products.

“APC148 has a unique mechanism-of-action versus other MBL-inhibitor products in pipeline making this a first-in-class product candidate,” says Bjørn Klem, CEO to Oslo Cancer Cluster (OCC).

AdjuTec Pharma has ambitious plans for the enzyme inhibitor, aiming to combine it with various antibiotics.

“APC148 can be combined with different broad-spectrum antibiotics, including carbapenems and cephalosporins. After intravenous administration, APC148 should preferably have comparable pharmacokinetics, meaning plasma profile, distribution and route of elimination from the human body as the antibiotic. There should be no interactions between the compounds,” Klem says to OCC.

World AMR Awareness Week

A global action plan to tackle the growing problem of resistance to antibiotics and other antimicrobial medicines was endorsed at the 68th World Health Assembly in May 2015. One of the key objectives of the plan is to improve awareness and understanding of AMR through effective communication, education and training. The World AMR Awareness Week takes place 18th to 24th November 2024.

Antimicrobial resistance

Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines, making infections harder to treat and increasing the risk of disease spread, severe illness and death. As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become increasingly difficult or impossible to treat.