Paradigm Biopharmaceuticals Ltd (ASX:PAR) has garnered parallel regulatory and ethics approvals from Europe’s Clinical Trial Information System (CTIS) in Belgium, Poland and the Czech Republic for its PARA_OA_002 clinical trial, targeting knee osteoarthritis (OA) pain.
The CTIS is a recently implemented system for the evaluation of clinical trial applications and harmonises regulatory and ethics committee reviews by European countries.
Single decision to proceed
Under the new regime, Paradigm’s iPPS dossier underwent simultaneous review by the three countries’ regulatory and ethics committees, resulting in a single decision to authorise the trial to proceed.
This is the regulatory green light for Paradigm to kick off clinical trial site start-up activities – including identifying and activating sites ahead of participant enrolment.
The company will now set about activating seven trial sites in these three countries.
"Harmonised approval"
“Paradigm’s pivotal PARA_OA_002 global clinical protocol continues to gain acceptance and approval by key regulatory bodies,” Paradigm managing director Paul Rennie said.
“The company has focused on gaining approval in Poland, Belgium and the Czech Republic due to the large pool of OA sufferers and number of experienced clinical trial sites with proven recruitment capabilities.
“This harmonised approval paves the way for further regulatory and ethics applications in additional European countries for the upcoming confirmatory phase 3 clinical trial, PARA_OA_003.”
The multicentre Phase 3 pivotal PARA_OA_002 clinical trial, which is set to take place in the US, Australia, the UK, the EU and Canada, will be randomised, double-blind and placebo-controlled, and will evaluate the dose and treatment effect of injectable pentosan polysulphate sodium (iPPS) in participants with knee osteoarthritis pain.
About the CTIS
The CTIS was established in Europe to support the implementation of clinical trial regulation and facilitates communication between clinical trial sponsors, European Union (EU) member states, European Economic Area (EEA) countries, and the European Commission throughout the lifecycle of a clinical trial.
The CTIS portal went live on January 31, 2022, and became mandatory for all clinical trial submissions from January 31 this year.