AdjuTec Pharma AS

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.

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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2024-02-14 13:17