Paradigm Biopharmaceuticals Ltd (ASX:PAR) (OTCMKTS:PBIGF) has received written feedback from the US Food and Drug Administration (FDA) regarding the investigational new drug (IND) submission for its pivotal study evaluating Pentosan Polysulfate Sodium (PPS) in knee OA.
The agency’s feedback contained its positions and questions principally in relation to recently completed non-clinical studies.
US FDA also provided suggested mitigation strategies to address its positions and questions, which included further detailed clinical monitoring.
Response within 30 days
Paradigm’s responses to the FDA questions will include mitigation strategies consistent with the FDA’s suggestions as well as clarification of existing study data.
The company is on track to submit its complete response to the agency within 30 days.
A review and response from the FDA will then be due within 30 days of the receipt of Paradigm’s response.
The IND 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 PPS.
It also describes the GMP manufacture of the active substance and the drug product used for the pivotal phase 3 studies.
Once the IND is ‘Open’ the company may begin recruitment and screening of participants for the study.
Phase 3 study preparation
In parallel, Paradigm is continuing Phase 3 study start-up preparation at sites in the US and Australia.
Additional sites may be added in order to ensure completion of this pivotal study, within the planned commercialisation timelines.
Story by ProactiveInvestors
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