Drug development company Paradigm Biopharmaceuticals (ASX:PAR) has received parallel regulatory and ethics approval for the PARA_OA_002 clinical trial in Belgium, Poland, and the Czech Republic.
The phase three pivotal PARA_OA_002 clinical trial is a randomised, double-blind, placebo-controlled, multi-centre study that will evaluate the dose and treatment effect of injectable pentosan polysulphate sodium (iPPS) in participants with knee osteoarthritis pain.
Paradigm reports the PARA_OA_002 application was submitted via Europe’s recently implemented CTIS for evaluation in these 3 European countries. As such, the company’s iPPS dossier underwent harmonised review by the 3 countries’ regulatory and ethics committees, resulting in a single decision to authorise the trial to proceed.
“Paradigm’s pivotal PARA_OA_002 global clinical protocol continues to gain acceptance and approval by key regulatory bodies”
Paradigm now has all the required approvals in place to begin clinical trial site start-up activities in these countries for the pivotal PARA_OA_002 global clinical trial.
The company reports it has identified sites and is in the process of activating up to 7 sites across the 3 countries to enrol participants with knee osteoarthritis into the PARA_OA_002 study.
Commenting on the approvals, Paradigm Biopharmaceuticals Managing Director Paul Rennie said: “Paradigm’s pivotal PARA_OA_002 global clinical protocol continues to gain acceptance and approval by key regulatory bodies. The company has focused on gaining approval in Poland, Belgium, and the Czech Republic due to the large pool of OA sufferers and a 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 three clinical trial, PARA_OA_003.”
Paradigm reports the CTIS has been established in Europe to support the implementation of Clinical Trial Regulation No 536/2014. The CTIS portal facilitates communication between clinical trial sponsors, 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 31 January 2022 and became mandatory for all clinical trial submissions from 31 January 2023.
Paradigm Biopharmaceuticals is a late-stage drug development company aiming to improve its patients and quality of life by discovering, developing, and delivering pharmaceutical therapies.
The company’s current focus is developing iPPS for the treatment of diseases where inflammation plays a major pathogenic role, indicating a need for the anti-inflammatory and tissue regenerative properties of PPS such as osteoarthritis, and mucopolysaccharidosis.