The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price has come under pressure on Monday morning following the release of an update on its osteoarthritis (OA) clinical program.
At the time of writing, the late stage drug development company's shares are down slightly to $2.60.
What did Paradigm announce?
This morning the company released an update on its Phase 3 OA clinical program. Paradigm advised that it made the announcement in order to provide clarification to the market on the expected timeline for the proposed clinical program.
According to the release, the company can now confirm that Phase 3 data will be generated by the first quarter of calendar year 2023. After which, the market will be informed of the top-line results once the clinical data has been analysed.
Unfortunately, this is slightly later that expected. Management was previously guiding to the fourth quarter of calendar year 2022. However, COVID-19 related delays in the written response from the US Food and Drug Administration (FDA) Type C meeting are behind this.
Paradigm advised that it submitted its briefing documents to the US FDA Type C meeting on 20 July.
What will the trial consist of?
Management explained that over the past 12 months it has been in regular contact with both the European Medicines Agency (EMA) and FDA regarding the Phase 3 clinical trial design.
In light of these discussions, it advised that the number of clinical trial subjects could be increased to reflect the probable feedback from the FDA Type C response.
Nevertheless, full details of the timing of the Phase 3 data and the numbers in each study will be presented at the company's upcoming research and development day on 21 December 2020. It notes that this is as soon as possible after it anticipates receiving the Type C meeting feedback.
