The Paradigm Biopharmaceuticals Limited (ASX: PAR) share price is up 9.03% at the time of writing after the healthcare company reported strong results from its clinical studies. Paradigm's drug Zilosul reportedly reduced chronic pain in osteoarthritis patients by 44.9%.
What does Paradigm Biopharmaceuticals do?
Paradigm Biopharmaceuticals an Australian biopharmaceutical company focused on repurposing the drug pentosan polysylphate sodium (PPS) for the treatment of osteoarthritis. PPS is an FDA approved drug with a 60-year track record of treating inflammation. Paradigm has developed an injectable form of PPS (Zilosul), which is registered in 4 of 7 global pharmaceutical markets.
What is Zilosul?
Zilosul is intended to treat osteoarthritis, which is the most common joint disorder in the United States (US). Symptomatic knee osteoarthritis occurs in 10% of men and 13% of women aged 60 years and over. This population is likely to increase due to the ageing population and obesity epidemic. There are more than 100 million osteoarthritis sufferers in the US, Europe, and Japan.
Clinical trials
Paradigm is conducting a trial into the use of Zilosul to treat osteoarthritis under the FDA's expanded access program. Data from 34 patients using Zilosul showed their chronic pain response demonstrated a mean reduction of 44.9%. Preparations for phase 3 trials are in train with endpoints agreed with the FDA. Two phase 3 trials will be conducted consisting of 750 and 400 patients, respectively.
Paradigm's financials
Paradigm conducted a $35 million institutional placement on 8 April. Proceeds from the placement will be applied to the costs of the second phase 3 osteoarthritis trial. At the end of the March quarter, Paradigm had $74.5 million in cash and cash equivalents, and no debt.
Paradigm spent $2.4 million on research and development during the March quarter, but received government grants and incentives of $3.19 million. In the financial year to date, Paradigm has used $5.37 million in cash on operating activities (including R&D).
Outlook
Paradigm reported that the coronavirus pandemic is unlikely to have a material long term impact on the business. The final patient treated under the expanded access program is scheduled to receive their final dose of Zilosul in May. Results on the first 5 patients are expected this quarter, with results for all patients expected next quarter.
Following completion of its capital raise, Paradigm has reported a strong cash position that will fully fund the company through to the completion of its phase 3 trials.
