Oslo, Norway, 8 May 2024 – AdjuTec Pharma AS is a privately held company developing antibiotic resistance breakers. The Company has received approval to start its first APC148 phase 1 clinical trial by the Swedish medical products agency.
Adjutec submitted, earlier this year, an application to the Swedish authority for starting a single-dose-ascending study of APC148 in healthy volunteers. The study will give Adjutec valuable human pharmacokinetic and safety data of our lead compound. An approval was anticipated before summer, but the process with the Swedish authority was constructive and smooth, which accelerated the approval.
The manufacturing of APC148 drug product is on-going and the study will commence shortly after the summer at the facilities of Clinical Trials Consultants AB (CTC) in Uppsala, Sweden.
Adjutec submitted, earlier this year, an application to the Swedish authority for starting a single-dose-ascending study of APC148 in healthy volunteers. The study will give Adjutec valuable human pharmacokinetic and safety data of our lead compound. An approval was anticipated before summer, but the process with the Swedish authority was constructive and smooth, which accelerated the approval.
The manufacturing of APC148 drug product is on-going and the study will commence shortly after the summer at the facilities of Clinical Trials Consultants AB (CTC) in Uppsala, Sweden.
"This is excellent news, reaching an important milestone in the short history of Adjutec. With limited resources, we have been able to reach the clinical phase of APC148 development. It has been a fabulous effort from our team and our collaborators. The approval is a great motivation to continue preparations for the upcoming clinical studies in 2025”, comments Bjørg Bolstad, CCRO (Clinical & Regulatory) of AdjuTec Pharma.
About antimicrobial resistance (AMR) – https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
AMR is a global health threat with an estimated 5mill associated deaths, including 1.27mill deaths attributable to bacterial AMR in 2019. WHO has declared that AMR is one of the top 10 global public health threats facing humanity. Misuse of antimicrobials is the main driver in the development of drug-resistant pathogens. AMR results in prolonged hospital stays at intensive care units with increased costs to the healthcare system. Without effective antimicrobials, the success of modern medicine in treating and preventing infections during major surgery and cancer chemotherapy, can be jeopardized.
About AdjuTec Pharma
AdjuTec Pharma is a company that is dedicated to developing and providing novel antibiotic resistance breakers to the global market. The company technology offers a unique mechanism of action that inactivates bacterial defence enzymes and restores bacterial sensitivity to antibiotics. The company’s lead product is APC148, a selective zinc chelator targeting bacterial metallo-ß-lactamase (MBL) enzymes. The technology was invented by Professor Pål Rongved and his group at the Department of Pharmacy, University of Oslo. The Company is located at St. Olavs gate 5, 0165 - downtown Oslo.
For more information, please visit www.adjutecpharma.com
Please contact: info@adjutecpharma.com
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