NEWS | BEAM Alliance


AdjuTec Pharma Submits First Clinical Trial Application (CTA)

Oslo, Norway, 14 February 2024 – AdjuTec Pharma AS is a privately held company developing antibiotic resistance breakers. Today the Company submitted the first CTA to the Swedish Medicinal Product Agency (MPA) to start a clinical phase 1 study with its lead compound APC148.

Adjutec completed the first part of the preclinical program with APC148 in 2023 to support a phase 1 single-ascending-dose study in healthy volunteers. The clinical study will generate important pharmacokinetic and safety data in humans to understand the distribution and elimination of APC148 after intravenous administration. These data will be important to define a safe dose before combining it with a broad-spectrum antibiotic and enzyme inhibitors. The study will be performed at the Clinical Trial Consultants clinic in Uppsala, a specialised phase 1 unit located within the Uppsala University Hospital.

“It has been a fantastic effort from the whole team, working closely with all our service providers to obtain the documentation needed to complete this application. We have been in close contact with MPA to meet their requirements and are looking forward to work with the agency in the approval process. This is a great milestone in the development of APC148 and we anticipate to get the “green light” from MPA before Summer”, comments Bjørg Bolstad, CRCO (Regulatory and Clinical) of AdjuTec Pharma.

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