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- Paradigm Biopharmaceuticals (PAR) is preparing its investigational new drug (IND) application for Zilosul to submit early next year after receiving feedback from the U.S. Food and Drug Administration (FDA)
- The FDA provided guidance for the design for the pivotal study investigating Zilosul as a treatment for osteoarthritis as well as for a future New Drug Application submission
- Paradigm has already sought guidance from the European and Australian regulatory agencies to ensure the same clinical trial protocol can be used for submissions in all jurisdictions, saving time and resources
- Given the feedback, Paradigm will increase the number of study participants and will share the full details in its R&D day on December 21, 2020
- Shares have been trading 3.9 per cent lower at $2.44 at 11:29 am AEDT
Paradigm Biopharmaceuticals (PAR) is preparing its investigational new drug (IND) application for Zilosul to submit in the first quarter of 2021.
The company recently received feedback from the Food and Drug Administration (FDA) following a Type-C meeting with the U.S. agency in July 2020.
FDA feedback
The FDA provided feedback on the design of the pivotal study for Zilosul as a treatment for osteoarthritis, including the primary endpoint, patient population, analysis plan and safety population.
Paradigm has already sought guidance from the European Medical Association and the Therapeutic Goods Administration to ensure the same clinical study protocol can be used for submissions in all jurisdictions, saving time and resources.
As a result of the feedback, Paradigm will increase the number of participants in the pivotal study and will share the full details in its R&D day on December 21, 2020.
The FDA also provided guidance on non-clinical studies and the retreatment schedule, given osteoarthritis is a chronic condition, which would support of possible future New Drug Application submission.
CEO and Interim Chairman Paul Rennie said Paradigm is now confident it has all the information it needs to make the IND submission for Zilosul in the first quarter of 2021.
“Paradigm has appointed its contract research organisation in the U.S. and Australia. Paradigm can confirm preparatory work on its pivotal phase three clinical trial has commenced but obviously no clinical trial subjects can be treated, with the investigational product, until the FDA IND is open.”
The pivotal study
The pivotal phase three trial, PARA002, will enrol participants at up to 55 sites in the U.S. and 10 sites in Australia from mid next year. The trial will first determine the minimum effective dose and then evaluate both safety and efficacy.
Paradigm anticipates it will be able to report top-line results from the study in the first quarter of 2023.
The phase three study will be followed by a confirmatory study, PARA003, which yield top-line data in the third quarter of 2023, based on the current timeline.
Shares have been trading 3.9 per cent lower at $2.44 at 11:29 am AEDT.
