The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price rallied 9.6% in morning trade before pulling back to a gain of 0.9% at the time of writing. The rise in the Paradigm share price came after the company reported pain reduction in osteoarthritis patients being treated under a United States FDA (Food and Drug Administration) expanded access program (EAP).
Osteoarthritis is caused by joint damage and is most often experienced by older people. It is a leading cause of disability and impacts 30 million men and women in the US alone.
The US EAP is a compassionate-use pathway for investigative treatments where there is no comparable or satisfactory therapy options outside clinical trials. However, this is monitored by the FDA and requires the cooperation of the healthcare organisation.
Update
In the update, Paradigm reported a 65% pain reduction in patients with osteoarthritis 12 weeks following the initiation of treatment with company's product, 'Zilosul'. This was using the 'WOMAC Pain Subscale'. The WOMAC Pain Subscale is a self-administered measurement tool used to assess the severity of pain.
Pleasingly, patients in the program reported improvements in pain felt whilst performing common daily tasks such as walking, using stairs, sitting and standing. Patients also reported a reduction in night pain.
Additionally, patients reported tolerance to the treatment with no adverse side effects reported. Patients also released testimonials regarding their satisfaction with the program. The company has released videos featuring professional NFL players detailing their experiences with osteoarthritis caused by joint injuries sustained during their careers.
Furthermore, Paradigm believes if replicated in a confirmatory Phase 3 clinical study, Zilosul would provide an alternative to the current treatments of moderate to severe osteoarthritis pain. At present, the treatment is NSAIDs (nonsteroidal anti-inflammatory drugs) and Opioids which have undesirable side effects.
CEO comments
Paradigm's CEO and Interim Executive Chairman, Paul Rennie said "This is a fantastic outcome not only for Paradigm as our first treatment of a cohort of patients in the US under an FDA approved program, but also for all patients that have participated in the program". He went on to say "We are very encouraged with the EAP results which were reported at 12 weeks, with the same pain scoring system Paradigm (we) will use in its Phase 3 clinical trial…".
About the Paradigm share price
Paradigm was listed on the ASX in August 2015. Its focus is on repurposing pentosan polysulphate sodium (PPS). A key feature of PPS is its anti-inflammatory and tissue regenerative properties.
Additionally, injectable PPS is not currently registered in Australia however it is registered in four of seven major global pharmaceutical markets.
Presently, the Paradigm share price is trading at $3.27 which represents a gain of .93% in today's trade.
