With progress to secure regulatory approvals underway for its flagship Zilosul treatment, Paradigm Biopharmaceuticals (ASX: PAR) is also gearing up for phase 2/3 clinical trial in the first quarter of next year.
Paradigm is preparing for a joint advice application with the US Food and Drug Administration, and European Medicines Agency (EMA) in Europe to discuss the upcoming phase 2/3 trial for its Zilosul drug in treating knee osteoarthritis with subchondral bone marrow lesions.
According to Paradigm, meeting with the FDA and EMA will provide clarification on the upcoming trial design to underpin regulatory approvals in both regions.
Trial preparations also include Paradigm engaging in a pre-investigational new drug (IND) meeting with the FDA.
Meanwhile, Paradigm anticipates reporting on updated data from the Australian Therapeutic Goods Special Access Scheme program involving approximately 400 knee osteoarthritis patients in the June quarter of next year.
A treatment program under the expanded access program of 10 knee osteoarthritis sufferers with bone marrow lesions will also begin shortly in January.
Conferences and key appointments
In addition to the trial and regulatory plans for 2020, Paradigm will be attending the 38th JP Morgan Healthcare conference next month in Sand Francisco.
While there, Paradigm plans to meet with US Biotech companies and healthcare funds.
The following month in February, Paradigm will be present at the 15th World Symposium 2020 Lysosomal diseases research and conference in Orlando.
Meanwhile, to shore up the company’s efforts in securing regulatory approvals, Paradigm has appointed Dr Donna Skerrett to its team as New York-based chief medical officer.
According to Paradigm, Dr Skerrett has extensive experience in US FDA IND filings.
Next month, Paradigm’s investor relations team will expand with the appointments of Mitch Marrow in the US and Simon White in Australia.
Paradigm noted that both have extensive financial industry experience in addition to being high profile ex elite sportspeople.