viewParadigm Biopharmaceuticals Ltd

Paradigm Biopharmaceuticals completes recruitment for knee pain trial

The trial is being conducted at six sites in four states across Australia.

concept representing clinical trial
Notably, iPPS is neither an opioid nor a steroid and is non-addictive

Paradigm Biopharmaceuticals Ltd (ASX:PAR) has recruited 100% of participants for its phase IIb clinical trial evaluating injectable pentosan polysulfate sodium (iPPS).

The randomised double-blind placebo-controlled trial aims to evaluate the effect of iPPS on knee pain in participants with knee osteoarthritis and subchondral bone marrow lesions.

The company expects to report the results of the pivotal phase IIb clinical trial by late in the December quarter 2018.

READ: Paradigm Biopharmaceuticals patients report over 50% pain reduction

Paradigm’s CEO Paul Rennie said: “The Paradigm clinical and regulatory team along with all the clinical trial recruitment and treatment centres have done an extraordinary job to conclude the recruitment of this phase II clinical trial in just over 7 months.

"What further underlines the outstanding job is the Paradigm’s second phase IIa clinical study (Ross River virus) is also nearing completion of recruitment.”

No adequate pain relief available

The iPPS has the potential to be a break-through in the treatment of osteoarthritis, where current therapies do not have adequate pain-relieving effects and are associated with adverse side effects.

Demand for an effective non-addictive alternative pain treatment has been amplified by the opioid epidemic in the US.

US FDA supporting new pain treatments

The US Food and Drug Administration (FDA) is taking steps to address the many facets of the complex opioid public health crisis.

Its goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids.

Quick facts: Paradigm Biopharmaceuticals Ltd

Price: 3.24 AUD

Market: ASX
Market Cap: $728.18 m

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