Oslo, Norway, 28 June 2023 – AdjuTec Pharma AS is a privately held company developing antibiotic resistance breakers. The company recently met with the Swedish Medical Products Agency (MPA) for scientific advice on our planned clinical Phase 1a study. The Swedish MPA comments supported the Company’s non-clinical package and further plans for a Clinical Trial Application (CTA) with APC148.
Adjutec is planning to apply for starting a clinical phase 1a dose-escalating study in healthy volunteers with APC148, end of 2023. This first-in-human (FIH) study will investigate safety and pharmacokinetics to establish a dose for the next phase 1b study. The phase 1b study is also a dose-escalating study but includes a broad-spectrum antibiotic combined with APC148. This study will investigate the safety and pharmacokinetics of the combination, defining a safe dose for entering the phase 2/3 program.
The Swedish MPA asked for clarifications and some additional data, which will be provided to support the applications for the clinical phase 1a and phase 1b studies.
It is important to receive feedback from regulatory medical authorities early in drug development to secure the non-clinical and clinical programs. Adjutec met with both FDA and EMA previously and this time it was important to discuss with the Swedish MPA as the phase 1 program will take place in Uppsala, Sweden.
Adjutec is planning to apply for starting a clinical phase 1a dose-escalating study in healthy volunteers with APC148, end of 2023. This first-in-human (FIH) study will investigate safety and pharmacokinetics to establish a dose for the next phase 1b study. The phase 1b study is also a dose-escalating study but includes a broad-spectrum antibiotic combined with APC148. This study will investigate the safety and pharmacokinetics of the combination, defining a safe dose for entering the phase 2/3 program.
The Swedish MPA asked for clarifications and some additional data, which will be provided to support the applications for the clinical phase 1a and phase 1b studies.
It is important to receive feedback from regulatory medical authorities early in drug development to secure the non-clinical and clinical programs. Adjutec met with both FDA and EMA previously and this time it was important to discuss with the Swedish MPA as the phase 1 program will take place in Uppsala, Sweden.
“This was a scientific advice meeting, and a final review of the documentation will be performed when the application for a phase 1a clinical trial has been submitted. However, the comments from the Swedish MPA were encouraging and supported our plans for a submission end of this year, comments Chief of Regulatory and Clinical Research (CRCR) Bjørg Bolstad.
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
Follow us on LinkedIn and Twitter
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
Follow us on LinkedIn and Twitter