AdjuTec Pharma is developing solutions to tackle antimicrobial resistance (AMR), a global health threath where bacteria resist antibiotics. If unchecked, AMR could lead to a 100 trillion USD global economic loss and causing 39 million deaths by 2050.
AdjuTec Pharma’s flagship drug, APC148, is a new generation zinc inhibitor targeting Metallo-Beta-Lactamases (MBLs) – enzymes that bacteria use to destroy antibiotics, making infections harder to treat. In late 2024, the company launched its First-In-Human SAD study, conducted by Clinical Trial Consultants in Uppsala, to evaluate APC148’s safety, tolerability, and pharmacokinetics (i.e. how the drug moves through the body) in healthy volunteers. This information is key for determining a safe and effective dosing.
All 46 subjects tolerated the drug well, with full results expected in Q2 2025. These findings will guide the development of an antibiotic product combing APC148 with meropenem (broad-spectrum antibiotic) and another enzyme inhibitor to create a most powerful drug combination (APC301) against multidrug resistant gram negative bacteria.
– APC148 is at core of our MBL-inhibitor platform technology and to witness the success with our first clinical trial was a huge exitement for the company. We are now moving forward with the APC148 clinical program combining it with meropenem and another enzyme inhibitor. – Chief Clinical and Regulatory officer Bjørg Bolstad,
While planning for more clinical trials with APC148 AdjuTec is now preparing for a new fundraising round to secure private investment during mid-2025.
A closer look at the study
The phase I SAD study involved 46 healthy adults split into six groups, each receiving ascending doses of APC148 as intravenously over three hours. The study was double-blinded and subjects were randomized to APC148 and placebo The participants included 34 males and 12 females aged 18-59 years. Subjects were tested for vital signs and blood biochemistry. All participants completed the study without any dropouts, ensuring robust data for analysis.
A promising start
No serious side effects were reported, all events reported were mild and transient The study examined how the APC148 plasma level rose by increasing the dose. The drug blood concentration showed a linear increase through all dose levels, securing predictable dosage regimens. APC148 was reduced in the body by 50% every 2,6 hours on average, mainly excreted through the kidneys.
A potential game-changer
AdjuTec Pharma’s explicit goal is to show that APC148 will stop bacteria enzymes from breaking down antibiotics, restoring treatment efficacy. The human safety data provided by this phase 1 SAD showed APC148 to have an excellent safety profile within the dose interval tested.
Recent preclinical efficacy testing show that combining APC148 with meropenem and another enzyme inhibitor (APC301) gives us the most powerful product in the pipeline at the moment.
Combined with promising preclinical efficacy, this phase 1 study supports APC148’s continued clinical development. In a comment to BioStock, Jethro Holter says:
– Together with the excellent preclinical efficacy data, these phase 1 safety results has reduced project risk of the project significantly and support APC301 as a game-changing new treatment for patients with multidrug resistant infections.
Also read: AdjuTec Pharma’s CEO: “Our goal is to set a new standard in antibiotic treatment”
