In morning trade the Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is climbing higher.
At the time of writing, the biopharmaceutical company's shares are up 2% to $2.59.
Why is the Paradigm share price rising?
Investors have been buying the company's shares this morning after it announced that it has received feedback from the US Food and Drug Administration (FDA). This is in relation to its Zilosul product for the treatment of osteoarthritis.
According to the release, having received the FDA's feedback, the company can confirm that the same clinical trial protocol will be used in the USA, Europe and Australia. Management is optimistic that this has the potential to enable registrations in multiple jurisdictions, saving time and money.
However, in order to achieve regulatory harmonisation across the FDA and European Medicines Agency (EMA), Paradigm will increase the proposed number of clinical trial study participants in its osteoarthritis clinical program.
Investigational New Drug (IND) application.
Paradigm has also revealed that it is now finalising its IND for submission to the FDA in the first quarter of calendar year 2021.
It has already begun the planning and start-up phase for Zilosul and once the IND is open, clinical trial participants from the USA and Australia will be enrolled into its pivotal Phase 3 randomised double-blind, placebo controlled, multicentre, multinational clinical trial (PARA002).
PARA002 will firstly determine the minimally effective dose and then investigate the safety and efficacy of Zilosul in subjects with osteoarthritis.
Management aims 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 calendar year 2023.
Paradigm's CEO and Interim Chairman, Paul Rennie, commented: "Paradigm is grateful to the US FDA for their feedback. 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 Q1 CY 2021."
"Paradigm has appointed its CRO 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," he added.
