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- Paradigm Biopharmaceuticals has filed its first investigational new drug (IND) submission to the US FDA (Food and Drug Administration) for its Zilosul product
- Paradigm says its product has potential as a first line of treatment of osteoarthritis and other diseases affecting the musculoskeletal system
- The company will trial Zilosul on ten people in the USA which include retired NRL players
Paradigm Biopharmaceuticals has filed its first investigational new drug (IND) submission to the US FDA (Food and Drug Administration) for its Zilosul product.
The Zilosul is an injectable Pentosan Polysulfate Sodium (iPPS) and is currently not registered in Australia but is registered in the four out of seven major global pharmaceutical markets.
Paradigm says its product has potential as a first line of treatment of osteoarthritis and other diseases affecting the musculoskeletal system.
The company will trial Zilosul on ten people in the USA which include retired NRL players who have early on-set osteoarthritis and have failed the standard of care.
Osteoarthritis is a condition which affects the whole joint including bone, cartilage, ligaments and muscles. It leads to chronic pain, disability and a decreased quality of life.
A US study showed that 44.7 per cent of people will have a lifetime risk of developing symptomatic knee osteoarthritis before age 85 years.
“In males under the age of 60, arthritis is over 3 times more prevalent in retired NFL players than in the general U.S. population. This excess of early-onset arthritis may be due to the high incidence of injury in football,” the announcement stated.
Paradigm Biopharmaceuticals is an Australian biopharmaceutical company that focuses on repurposing the drug pentosan polysulphate sodium (PPS) for the treatment of inflammation.
An IND is a request for authorisation from the US FDA to see if the drug or biological product is suitable for humans.
The IND is expected to be cleared in 30 days and if successful the treatment of the ten Americans will occur in September.
The company announced its phase 2b clinical trial indicated several patients receiving iPPS treatment had a clinically meaningful reduction in the grade of their Bone Marrow Edema Lesions (BML) compared to a placebo.
The iPPS group’s reduction was also statistically significant over placebo at 50% vs 27.3% (P=0.03) by Chi-squared analysis.
Currently, Paradigm is undergoing commercial discussions with potential partnership deals and commercial transactions.
