- Paradigm Biopharmaceuticals (PAR) has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA)
- This marks the first major submission for Paradigm’s study of its Zilosul drug in patients with knee osteoarthritis (OA)
- This IND submission keeps Paradigm on track to begin enrolment of patients and 60 of the planned 65 sites have begun preparation for recruitment
- It can also begin clinical trials in EU member countries following a meeting with the European Medicines Agency
- Paradigm is up 5.42 per cent on the market and shares are trading at $2.53
Paradigm Biopharmaceuticals (PAR) has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA).
This marks the first major submission for Paradigm’s study of its Zilosul drug in patients with knee osteoarthritis (OA).
In February 2020, Paradigm attended a pre-IND meeting and met with the FDA to discuss the trial protocol and receive feedback.
The company also met with the European Medicines Agency (EMA) and achieved regulatory engagement, meaning it can begin clinical trials in EU member countries.
“This IND submission is the product of several informative meetings with the U.S. FDA and EMA where Paradigm’s clinical and regulatory teams received critical feedback on the requirements of the data package for submission and overall clinical trial design to ensure it would meet the regulators needs for registration,” Chief Medical Officer Dr Donna Skerrett commented.
This IND submission keeps Paradigm on track to begin enrolment of patients and 60 of the planned 65 sites have begun preparation for recruitment.
Furthermore, upon execution of a successful clinical trial program, Paradigm is confident that it will proceed with simultaneous registration for Zilosul in multiple key regions.
Zilosul, a pentosan polysulfate sodium (PPS), is a semi-synthetic drug that is sulphated to produce a negatively charged product that mimics glycosaminoglycans (large molecules that consist of repeating units).
PPS’s can be used in the treatment on inflammation, deep vein thrombosis and bladder conditions.
“We believe that a harmonised clinical trial program that satisfies the requirement for registration with multiple global regulatory agencies will save Paradigm time and money as we approach registration and commercialisation of Zilosul,” Chairman and CEO Paul Rennie said.
“We look forward to providing further detail on the final study design and timing once the IND has been opened following the 30-day review period with the FDA,” he added.
Paradigm is up 5.42 per cent on the market and shares are trading at $2.53 at 10:44 am AEDT.