Paradigm Biopharmaceuticals Ltd (ASX:PAR) has made the first major submission for its planned Pivotal study in subjects with pain associated with Knee Osteoarthritis (OA) by submitting an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).
The submission includes reports on the phase 1 study in healthy volunteers completed in quarter four of 2020 as well as several non-clinical studies that detail the pharmacokinetics and toxicology of Pentosan Polysulfate Sodium (PPS).
It also describes the GMP manufacture of the active substance and the drug product used for the pivotal phase 3 studies.
This marks a significant milestone for the company with the focus now on the planned Pivotal study (Para_OA_002) and Extension study (Para_OA_006) with PPS (Zilosul®) for the treatment of patients with Knee OA.
Shares have been as much as 6.,7% higher intra-day to A$2.56 while PAR’s market cap is approximately A$575.9 million.
“Timely milestone for company”
The submission of the IND within the current quarter keeps the company on track to enrol clinical trial subjects next quarter.
Paradigm chairman and CEO Paul Rennie said: “It has been incredibly pleasing watching all modules of the IND submission come together and I am very thankful for the highly experienced and skilled Paradigm team for achieving this significant milestone on time for all of our stakeholders.
“We believe that a harmonised clinical trial program that satisfies the requirements for registration with multiple global regulatory agencies will save Paradigm time and money as we approach registration and commercialisation of Zilosul®.”
Ready to begin trial recruitment
Once the IND is ‘Open’ the company may begin recruitment and screening of participants for the study.
Site selection is close to being finalised in the US and Australia with 60 of a planned 65 sites already approved to participate in the clinical trial.
Rennie said: “We anticipate the IND opening will provide further exposure to global investors and partners with the company already receiving an increase in global interest in our Phase 3 clinical program during our attendance this week at the 2021 BIO-Europe Spring Partnering conference where the company has participated in several partnering meetings.
“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”.
“Harmonised global clinical trial design”
The company is confident after seeking this critical feedback from both FDA and EMA, it will proceed with simultaneous registration for Zilosul® in multiple key regions, upon execution of a successful clinical trial program.
Paradigm CMO Dr Donna Skerrett said: “This IND submission is the product of several informative meetings with the US 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.
“This led to adjustments in the OA clinical program to make sure Paradigm would have all necessary data to not only open the IND but also to have a harmonised global clinical trial design.
“We believe the process of gaining this important feedback from multiple regulators has de-risked our overall clinical program giving us confidence that should our Pivotal and Confirmatory studies be successful, the company will have all necessary data required for registration of Zilosul® at a minimum with the FDA, EMA and TGA.”
Based on the EMA feedback, applications to commence clinical trials in EU member countries may begin, with a clear path to product registration.
Story by ProactiveInvestors
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