AdjuTec Pharma Kicks Off Phase I Trial For New Antibiotic APC148

AdjuTec Pharma is gearing up to begin its Phase I clinical trial for APC148, an enzyme inhibitor aimed at tackling antibiotic resistance. Set to commence on September 18 in collaboration with CTC in Uppsala, the trial will focus on evaluating the drug’s safety. This marks a crucial step as AdjuTec transitions from preclinical studies to clinical-stage development, addressing the global challenge of antibiotic resistance.

Based in Norway, AdjuTec Pharma specializes in developing innovative solutions for antibiotic-resistant infections. Their flagship drug, APC148, is designed to inhibit metallo-β-lactamase (MBL) enzymes, which bacteria use to shield themselves from antibiotics. While serine-β-lactamases (SBL) are already targeted by existing treatments, MBL enzymes continue to pose a challenge.

Over the past few years, AdjuTec has accumulated extensive preclinical data supporting APC148’s efficacy, safety, and scalability. With regulatory approval from the Swedish Medical Products Agency (MPA), the company is now ready to advance the drug into the clinical phase, bringing it closer to market.

“For three years, Adjutec has worked hard to advance preclinical activities to become a clinical-stage company. With the approval from the MPA and the recent release of the APC148 drug product, we’re excited to start the first administration of APC148 to humans on September 18”, said CEO Bjørn Klem.

The clinical trial for APC148 will be carried out by Clinical Trial Consultants (CTC) in Uppsala, marking the first time the drug will be tested in humans. This single-ascending dose (SAD) study is designed to assess the safety of APC148 in healthy adult participants. The trial will include 5 to 6 dose levels, with each group comprising eight individuals – six receiving the active drug and two on a placebo.

Participants will receive the drug intravenously over a three-hour period. After each dose escalation, a thorough review will be conducted to ensure the safety of those involved. AdjuTec aims to complete the study by early 2025, after which it plans to proceed with a multiple-ascending dose (MAD) trial involving repeated administrations over several days.