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Paradigm Biopharma (ASX:PAR) has announced its completion of a submission to the US FDA to progress to Phase III of its osteoarthritis treatment ‘program.’
Within the application Paradigm bundled the results of five nonclinical studies as well as data from the company’s recent phase 2 clinical trial.
Further data on 600 participants doses in stage 1 of a clinical program that used another product was also submitted.
Paradigm said on Friday most of the data submitted has not yet been assessed by the FDA.
The company is focused on commercialising the use of injectable Pentosan Polysulfate Sodium (iPPS). Paradigm has reported in the past success in reducing cartilage loss.
The company is hoping to get the greenlight to establish a dosing regimen of 2mg/kg twice weekly for one and a half months, as well as approval to move to Phase III.
The company expects a response from the FDA within the next ninety days or so. It had to send off a revised safety plan in its latest batch of submissions.
At the same time, the company is preparing similar materials for submission to the Australian counterpart to the FDA, the Therapeutic Goods Administration (TGA).
The company also continues to seek to get supporting science published in different academic journals.
“This is important progress for Paradigm as we deliver a significant amount of new data to the US FDA for review to progress to the next stage of the phase 3 OA program,” Paradigm chief Paul Rennie said.
“We have treated close to 700 participants under a clinical trial setting with various iPPS doses, which provides strong justification that 2 mg/kg twice weekly is [ideal].
“We look forward to receiving the FDA’s feedback and … updating on the outcome of the agency’s review and planned execution of the phase 3 clinical program.”
PAR shares opened on Friday at 28.5cps.
