Paradigm Biopharmaceuticals submits responses to US FDA questions regarding Investigational New Drug application

Paradigm Biopharmaceuticals Ltd’s (ASX:PAR) (OTCMKTS:PBIGF) submitted responses to the US Food and Drug Administration (FDA) regarding questions on its Investigational New Drug (IND) application have been received.

In preparing its response, Paradigm consulted with multiple experts, including a US board-certified pre-clinical toxicologist and a senior former FDA physician to review the document and ensure the document contains sufficient information to be completely responsive to the questions raised by the agency.

Paradigm believes the input from these experts increase the likelihood that its response will meet the FDA requirements to be considered complete and sufficient for proceeding.

The FDA will now review Paradigm’s responses over the next statutory 30-day period within which they are required to respond.

Paradigm will notify the market once it has been notified of an outcome by the FDA.

Diligent review process

PAR chief medical officer Dr Donna Skerrett said the company responded to the FDA’s questions following diligent reviews with its internal team and consultants.

She added: “We believe these responses are sufficient to assure the agency the program is supported by non-clinical and clinical data and that the objectives, rationale, and study design will aim to demonstrate the safety and effectiveness of PPS for patients with painful osteoarthritis of the knee.

“There is a clear unmet need for patients who have not had adequate responses to initial therapy for knee OA and have ongoing pain.

“Prior experience with PPS in clinical and non-clinical settings has demonstrated the potential to address this unmet need.”

Progressing clinical studies

Paradigm chief executive officer Paul Rennie said: “I would like to highlight that Paradigm, during the self-imposed 30-day response time to the FDA questions, has progressed pre-clinical studies in two new indications of acute respiratory distress syndrome (ARDS) and heart failure at study centres in Australia and Europe, respectively.

“As recently announced, the orphan drug indication of MPS VI has received regulatory and ethics approval in Brazil for its Phase 2 clinical trial.

“Paradigm continues to execute on its disease-modifying osteoarthritis clinical trial PARA_008.

“The company has also filed two new patents over the use of PPS in new clinical indications with high unmet clinical needs.”

Story by ProactiveInvestors