Paradigm Biopharmaceuticals Ltd (ASX:PAR) will host its first research & development (R&D) day presentation on Monday, December 21, 2020, to update investors on Zilosul® in osteoarthritis and other indications.
The late-stage drug development company said the presentation would cover its proposed clinical program, safety and an update on other indications in the company’s R&D pipeline.
Current and potential investors will be able to participate online via https://web.lumiagm.com on their smartphone, tablet or computer.
Details of the meeting are as follows:
The presentation will also include revenue timeline and summary.
Clinical trial program details
It will also offer a detailed explanation of the clinical trial program required to achieve successful global registration for osteoarthritis, based on feedback from the scientific advice meeting with the European Medicines Agency (EMA) in September and the TypeC meeting with the US Food and Drug Agency (FDA) expected in mid-December 2020.
PAR's chief medical officer will present an update on the clinical study plan, patient enrolment and the projected timeline for clinical readout/s as well as target dates for regulatory submissions
Type-C meeting feedback
The company looks forward to detailing the feedback from the Type-C meeting with the US FDA to investors once the written response has been received.
Paradigm had submitted the briefing pack to the FDA on October 23 for a Type C meeting to gather and consolidate feedback from the FDA, EMA and Australia’s Therapeutic Goods Administration (TGA).
The aim is to have a pivotal protocol acceptable to all major jurisdictions and streamline the approval process in multiple key markets.
Paradigm believes if a clear path to registration is established, with the US FDA and EMA’s input, prior to opening the IND and commencement of the Phase 3 clinical program, this will avoid a clinical trial design that does not adequately meet the requirements for registration.