Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received positive feedback from the Type-C meeting with the US Food and Drug Administration (FDA) on Zilosul® for the treatment of osteoarthritis.
The late-stage drug development company will now proceed to an Investigational New Drug (IND) submission in the first quarter of 2021.
It will use the same clinical trial protocol in the US, Europe and Australia, potentially enabling registrations in multiple jurisdictions, saving time and money.
To achieve regulatory harmonisation across the FDA and the European Medicines Agency (EMA), Paradigm will increase the proposed number of clinical trial study participants in its OA clinical program.
Preparatory work on Phase 3 trial
Paradigm chief executive officer and interim chairman Paul Rennie said: “Paradigm is confident that it has all the necessary information and clarity for a pivotal Phase 3 program to now make an IND application in the first quarter of 2021.
“Paradigm has appointed its CRO (clinical research organisation) in the USA and Australia.
“Paradigm can confirm preparatory work on its pivotal Phase 3 clinical trial has commenced but obviously no clinical trial subjects can be treated, with the investigational product (Zilosul®), until the FDA IND is open.”
IND application
PAR’s chief medical officer and executive director Dr Skerrett said: “The feedback confirmed the FDA’s views on the primary endpoint, patient population, statistical analysis plan, the safety population, re-treatment of patients with Zilosul (a re-treatment plan is expected as osteoarthritis is a chronic condition) and other general aspects of the clinical trial design including the use of placebo (saline).”
“Given this feedback, Paradigm is confident it can submit its Investigational New Drug (IND) application in the first quarter of 2021 and can continue with our harmonised global registration plans.”
Phase III trial timeline
Paradigm has already started the planning and start-up phase for Zilosul® and once the IND is open, clinical trial participants from the US and Australia will be enrolled into its pivotal Phase 3 randomised double-blind, placebo-controlled, multicentre, multinational clinical trial (PARA002).
The trial will firstly determine the minimally effective dose and then investigate the safety and efficacy of Zilosul in subjects with osteoarthritis.
Paradigm is targeting to enrol the first patient for its clinical program in mid-2021.
Based on this timetable, the company would expect top-line efficacy results in the first quarter of 2023.
It is proposing to have up to 55 sites in the US, with up to an additional 10 sites in Australia.
Confirmatory study in Europe
PARA003 is the confirmatory study for PARA002 and will confirm the safety and efficacy in clinical trial subjects from Europe.
Like PARA002, PARA003 will be a randomised double-blind placebo-controlled, multicentre, clinical trial and has a proposed top-line readout timeline in the third quarter of 2023.
To maximise the commercial value of the OA asset, Paradigm will undertake additional clinical studies, which will run concurrently with the pivotal Phase 3 clinical trials.
Further details will be shared at the company's inaugural Research & Development Day on December 21, 2020.