- Paradigm Biopharmaceuticals (PAR) is one step closer to launching phase three clinical trials after a meeting with the European Medicines Agency (EMA)
- The arthritis treatment company sought scientific advice from the agency in May and received it in September
- Now, Paradigm has some clear guidelines to kick off a phase three trial
- The company has outlined the trial’s design, primary endpoints, and patient population, based on the EMA advice
- Paradigm says applications to begin clinical trials in the European Union can now begin
- Shares in Paradigm are trading over eight per cent higher this morning and currently worth $2.47 each
Paradigm Biopharmaceuticals (PAR) is one step closer to launching phase three clinical trials after a meeting with the European Medicines Agency (EMA).
The arthritis treatment company will be testing its Zilosul drug in the trials to evaluate the reduction of pain in patients with osteoarthritis.
Paradigm sought advice from the EMA in May about the clinical trials and, after a September meeting with the agency, now has a clear path forward to get Zilosul registered in Europe.
Importantly, the company said applications to begin clinical trials in the European Union can now begin.
European Medicines Agency advice
The EMA is effectively the E.U. equivalent of the Unites States’ Food and Drug Administration (FDA).
The organisation is in charge of evaluating and supervising medical products in the E.U. to ensure they are safe and effective.
On top of this, the EMA gives scientific advice to medicine makers to support the development of new treatments. Essentially, the advice is designed to help these companies make sure they run the appropriate tests and studies so that the evaluation process is as smooth and efficient as possible.
For Paradigm, the company received guidance on the design of the trial, its statistical approach, what kind of patients should be enrolled, what the trial is looking to measure, and what type of placebo will be used.
Paradigm said based on the scientific advice, it will enrol patients who have moderate to severe osteoarthritis who do not respond to conventional approved treatments, and the trial’s primary endpoint will be Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index pain and function.
The company also said it will use saline as a placebo.
Paradigm’s Chief Medical Officer, Dr Donna Skerrett, said the advice from the EMA brings the company closer to taking Zilosul to market.
“The company remains focused on further demonstrating, via our phase three 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 osteoarthritis,” Donna said.
“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,” she said.
It seems shareholders are just as eager for Paradigm to kick off some clincial trials, with shares in the company rising 8.33 per cent in early action following today’s news.
At 10:58 am AEST, Paradigm shares are worth $2.47 each.