- The U.S. Food and Drug Administration has notified Paradigm Biopharmaceuticals (PAR) it will need longer to review its IND application
- Last month, Paradigm submitted an investigational new drug application (IND) for a pivotal study of Zilosul in treating knee osteoarthritis
- During the 30-day review period, the clinical-stage biopharmaceutical company responded to several questions from the FDA
- However, the regulator has informed Paradigm it will need more time to put forward queries and will do so in the next 30 days
- PAR is trading 4.1 per cent lower at $2.45
The U.S. Food and Drug Administration (FDA) has notified Paradigm Biopharmaceuticals (PAR) it will need longer to review its application.
Last month, Paradigm submitted an investigational new drug application (IND) for a pivotal study of Zilosul, or Pentosan Polysulfate Sodium, in treating knee osteoarthritis.
Once the IND application is ‘open’ and institutional ethics approvals are received, the company can begin recruiting patients to participate in the Para_002 clinical study which will take place at a planned 65 sites in the U.S. and Australia.
During the 30-day review period, the clinical-stage biopharmaceutical company responded to several questions from the FDA on the 30,000-page submission.
The regulator has, however, informed Paradigm it will need more time and will submit additional questions to the company in the next 30 days.
In addition to osteoarthritis of the knee, Paradigm is repurposing Pentosan Polysulfate Sodium as a treatment for other conditions — bone marrow lesions, chronic heart failure and alphaviral arthritis — due to its tissue regenerative and anti-inflammatory properties.
PAR is trading 4.1 per cent lower at $2.45 at 10:12 am AEDT.