The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is edging higher during early morning trade. This comes after the company provided an update on its Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).
The application concerns Pentosan Polysulfate Sodium or PPS. It’s an injectable solution that aims to treat musculoskeletal disorders caused by injury, inflammation, aging, degenerative disease, infection or genetic predisposition.
The semi-synthetic drug is packaged as Zilosul and has shown improvements in pain reduction, joint function, and the prevention of cartilage damaging joints.
At the time of writing, the biopharmaceutical company’s shares are up 3.61% to $2.01.
What did Paradigm announce?
In today’s statement, Paradigm advised it has responded to the FDA’s questions about its IND application.
Paradigm stated it consulted with multiple experts for its responses to the questions. This included a United States board-certified pre-clinical toxicologist and a former FDA physician who reviewed the document before submission.
The company believes with the help of these experts, the FDA will be satisfied with its responses. It hopes the matter will be considered complete and can proceed to the next steps of the process.
The FDA has 30 calendar days to decide on whether Paradigm’s submission meets requirements.
Paradigm chief marketing officer Dr Donna Skerrett commented:
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 nonclinical settings has demonstrated the potential to address this unmet need.
Paradigm CEO Paul Rennie also added:
Paradigm 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.
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.
Paradigm share price summary
During the past 12 months, Paradigm shares have lost almost 40% with its year-to-date performance also down more than 20%. The company’s share price reached a 52-week low of $1.87 yesterday.
Based on today’s price, Paradigm has a market capitalisation of around $439 million, with approximately 226 million shares outstanding.