The Australian biopharmaceutical company, Paradigm Biopharmaceuticals’ (ASX: PAR) shares went up by 12.5 percent today (i.e., 18 December 2018) after the company announced positive results from its phase 2B clinical trial of injectable pentosan polysulfate sodium (iPPS) in Knee Osteoarthritis pain.
Osteoarthritis is currently a leading cause of disability for people greater than 65 years of age, and it is the last frontier of blockbuster diseases with no treatment. Paradigm’s 2B clinical trial was conducted across six sites in Australia with the aim of evaluating the effects of iPPS on knee pain in subjects with knee osteoarthritis and subchondral bone marrow edema lesions (BMELs).
As per the results, the Clinical trial has met the primary endpoint with a change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) from baseline at Day 53. The outcomes of the trials have confirmed that iPPS (ZILUSOL®) is having the potential of being a safe and effective treatment of knee osteoarthritis pain. The company reported that 46.2 percent of subjects receiving iPPS demonstrated more than 50 percent reduction in pain from baseline as compared to 22.5 percent of subjects receiving Placebo under KOOS pain subscale in the NRS Pain = 4-6 strata. The key outcome from the trial is that clinically meaningful and statistically significant results between Placebo and iPPS were demonstrated across the total subject population and highly clinically meaningful and highly statistically significant results were demonstrated in the NRS pain = 4-6 stratum.
According to Paradigm’s CEO, Mr. Paul Rennie, to achieve clinically meaningful and statistically significant results between Placebo and iPPS, is truly an outstandingly positive trial outcome.
As a result of Paradigm's Phase 2b results, the company is planning to file a New Drug Application (NDA) with USA FDA for a pivotal Phase 3 in Calendar year 2019. It is expected that the outstanding Phase 2b results will reach the higher effect and statistical significance in larger Phase 3 clinical trial.
Now after the release of positive results from phase 2B clinical trial, the company is well positioned to execute many valuable milestones throughout 2019 which include the filing of Investigational New Drug (IND) application for Phase 3 trial in OA/BMEL with the possibility of being granted “fast track status” for the Phase 3 trial. The company is also planning to release Ross River Phase 2a trial results in the first quarter of the calendar year 2019. Further, there is a possibility of earning revenue in 2019 through receiving ‘Provisional Approval’ from TGA to sell Zilosul (iPPS).
In the last six months, the share price of the company increased by 78.38 percent as on 13 December 2018. PAR’s shares traded at $1.485 with a market capitalization of circa $184.55 million as on 18 December 2018 (AEST 2:43 PM).
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