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.
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.
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