- Paradigm Biopharmaceuticals first IND application has been cleared by America’s Food and Drug Administration within 30-day review period
- It submitted an Expanded Access IND application for pentosan polysulfate (PPS)
- PPS will treat 10 patients with pain associated with knee osteoarthritis
Paradigm Biopharmaceuticals first Investigational New Drug (IND) application has been cleared by America’s Food and Drug Administration within 30-day review period.
The company submitted an Expanded Access IND application for pentosan polysulfate (PPS).
PPS will treat 10 patients with pain associated with knee osteoarthritis with cocurrent bone marrow lesions. These patients have failed to respond to the standard of care for the disease.
The physician treating the patients, under the IND, is an ex-NFL player with the Green Bay Packers. Since his retirement from the NFL, Dr Michels, has worked primarily with sportspeople such as retired NFL Players.
A major risk factor for osteoarthritis is joint injury. Knee injury is a common injury amongst NFL players.
Retired NFL players under the age of 60 are three times more likely to get arthritis than the general U.S. population. According to the company, this could be due to the high injuries in the sport.
Osteoarthritis is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage that cushions the ends of your bones wears down over time.
Paradigm’s Phase 2b clinical trial showed the drug injected pentosan polysulfate sodium (iPPS) was able to reduce pain and improve joint function compared to the placebo.
iPPS is currently not registered in Australia, but it was previously registered in four
of the seven major global pharmaceutical markets. It is registered as an antithrombotic agent.
Osteoarthritis is a major cause of disability for which there are currently no products registered to modify the course of the disease. This represents a major global unmet medical need.
CEO Paul Rennie is pleased with the IND approval.
“This clearance demonstrates the need for effective and safe therapies for the serious chronic disease of osteoarthritis,” he said.
Paradigm is an Australian biopharmaceutical company that focuses on treating inflammation.
“Dr Michels will be treating people with osteoarthritis who have failed to respond to standard of care medications,” Paul said.
“Paradigm now looks forward to the completion of the Expanded Access Programme and reporting on those results in the months ahead,” he added.