Paradigm Biopharmaceuticals Ltd (ASX: PAR) updated the market today on its phase III trial and product registration in Europe. The news shot the Paradigm share price 8.3% higher to $2.47 at the time of writing. In comparison, the All Ordinaries Index (ASX: XAO) is trading marginally higher today at 0.2% to 6,152 points.
Let's look at what Paradigm announced.
European Medicines Agency meeting
Paradigm received positive feedback from a meeting with the European Medicines Agency (EMA) for its product Zilosul. The company is developing Zilosul to treat chronic knee pain resulting from osteoarthritis (OA). Today's regulatory milestone will provide a clear pathway for Zilosul registration in Europe.
The meeting with EMA covered key elements of Paradigm's phase III trials, pre-clinical and manufacturing processes. EMA agreed on the proposed adaptive clinical trial design, including the conduct of two global, multicentre and randomised studies. This will include moderate to severe patients who have failed to respond to non-steroidal anti-inflammatory drugs and paracetamol. Evaluation will be done through WOMAC pain and WOMAC function, and the use of a saline placebo arm. In addition, Paradigm confirmed that the trial would not include an active comparator.
The meeting is expected to support Paradigm's submission of a marketing authorisation application (MAA) in Europe targeting knee OA.
The company plans to submit the same phase III clinical trial protocol to the United States Food and Drug Administration (FDA). Paradigm hopes to receive similar feedback in its Type C meeting that will assist its IND and subsequent NDA submission. The company advised it will present its Type C briefing book to the FDA in the coming weeks.
What did management say?
Paradigm's chief medical officer, Dr Donna Skerrett, was upbeat about the feedback for Zilosul, saying:
Paradigm is very pleased with the valuable guidance received from the EMA which provides clear direction as we advance our Phase 3 registration program toward bringing Zilosul to market.
The company remains focused on further demonstrating, via our Phase 3 clinical trials, the potential for Zilosul to be a treatment for the huge population of people suffering with chronic knee pain as a result of OA. This is another step toward our aim to have the pivotal protocol acceptable in all major jurisdictions providing Paradigm with a clarified path to global approval of Zilosul should our clinical trials be successful.
About the Paradigm share price
The Paradigm share price reached an all-time high of $4.50 before the onset of COVID-19, falling more than 72% in March. However, the Paradigm share price has since recovered from its 52-week low of $1.08, up 127%.
