Paradigm moves on to phase three trials of Zilosul after EMA’s approval
Category: #health  By Saipriya Iyer  Date: 2020-09-28
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Paradigm moves on to phase three trials of Zilosul after EMA’s approval

According to reliable sources, Paradigm Biopharmaceuticals Ltd. has made headway towards the phase three trials of their drug Zilosul, which is used for the treatment of arthritis.

The recent development comes along the heels of a successful meeting with the EMA (European Medicines Agency), a decentralized unit of the European Union (EU) that oversees the supervision and scientific evaluation of the effectiveness as well as safety of medical products.

The EMA has offered a green signal for conducting tests of Zilosul in order to evaluate the drug’s pain reduction properties among osteoarthritis patients, sources claimed.

For the uninitiated, Paradigm Biopharmaceuticals is an Australia-based biopharmaceutical leader that focuses on the repurposing of PPS (pentosan polysulphate sodium), a drug used for the treatment of inflammation.

Reportedly, the EMA provided the company with guidelines, inclusive of the overall structure of the trial, the parameters to be measured and the type of patients to be enrolled.

Sources close to the matter claim that Paradigm will be using saline as a placebo on the patients in the third trial round. The subjects in the trials will include patients suffering from moderate to severe osteoarthritis and the primary endpoint of the trial will be WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index pain and function.

Dr Donna Skerrett, Chief Medical Officer of Paradigm Biopharmaceuticals was reported saying that the company persists to demonstrate the prospects of Zilosul for treating large populations of people suffering from chronic knee pain due to osteoarthritis.

She further stated that the EMA validation is a significant milestone in the global approval of Zilosul and that it will help the company in bringing the medicine closer to the market.

If reports are to be believed, the phase three trials are highly anticipated by Paradigm’s shareholders, which resulted in an 8.33% rise in the company’s shares.

 

Source credits: https://themarketherald.com.au/paradigm-biopharmaceuticals-asxpar-ready-to-launch-zilosul-trials-in-europe-2020-09-28/



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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