Oslo, Norway, 19 September 2024 – AdjuTec Pharma AS, a privately held company developing antibiotic resistance breakers, today announces the initiation of its phase 1, first-in-human clinical trial of its lead compound APC148 in healthy adult volunteers.
Adjutec has reached an important milestone in the commercialisation of its enzyme inhibitor technology. From years of preclinical development, the company has demonstrated APC148 to be safe and efficacious. Manufacturing of APC148 has successfully been scaled up to support the entire clinical program. After meetings with FDA, EMA, Swedish and Norwegian medicinal product agencies, Adjutec recently received the green light from Swedish authorities to initiate the phase 1 program. This week the company successfully administered the first intravenous dose of APC148 to volunteers at a clinic in Uppsala. The study is a single-dose-ascending study with the objective to evaluate the safety, tolerability and pharmacokinetics of APC148. Eight participants are included in each cohort, six subjects receiving APC148 and two subjects receiving placebo.
Adjutec has reached an important milestone in the commercialisation of its enzyme inhibitor technology. From years of preclinical development, the company has demonstrated APC148 to be safe and efficacious. Manufacturing of APC148 has successfully been scaled up to support the entire clinical program. After meetings with FDA, EMA, Swedish and Norwegian medicinal product agencies, Adjutec recently received the green light from Swedish authorities to initiate the phase 1 program. This week the company successfully administered the first intravenous dose of APC148 to volunteers at a clinic in Uppsala. The study is a single-dose-ascending study with the objective to evaluate the safety, tolerability and pharmacokinetics of APC148. Eight participants are included in each cohort, six subjects receiving APC148 and two subjects receiving placebo.
Having reached this phase 1 study is an exciting milestone for Adjutec and will give us important safety data and knowledge about how the human body handles APC148. The study is the first step to determine the dose to be used in patients with severe infectious disease for the phase 2-3 program. It will significantly derisk the project and trigger partnering activities in selected territories”, said Bjørn Klem, Chief Executive Officer.
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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