Paradigm Biopharmaceuticals Ltd (ASX:PAR) is in a trading halt with results pending for the company’s Phase 2b placebo-controlled OA/BMEL clinical trial.
The halt has been granted by the ASX and will remain in place until the start of normal trading on Tuesday, December 18, 2018, or when the announcement is released to the market, whichever occurs earliest.
Shares last traded at $1.32 after reaching a new 12-month high of $1.63 earlier this month.
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Paradigm is focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS), a US Food and Drug Administration (FDA) approved drug that has a long track record of safely treating inflammation.
The company is working on several clinical indications for orthopaedic treatment of OA, BMEL, Ross River virus and Chikungunya and plans to establish commercial partnerships with pharmaceutical companies.
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Data was recently received from an additional 38 patients with knee OA that were treated with iPPS.
Combining these results with those previously reported for 145 patients brings the on average reduction in pain scores to 51.4% across the 183 patients.
The results continue to be superior to the typical 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.
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Paradigm’s CEO Paul Rennie said: “We are very pleased to see that since October 2017 and after the report of the seventh group of Real World Evidence patients there is a consistent average knee pain reduction of greater than 50% in the 183 patients.
“Of important relevance is that Paradigm has accumulated data on 183 patients being successfully treated with iPPS for OA associated BMELs.
“The number of patients seeking treatment via the TGA SAS is a strong feedback that the patients are receiving a clinically meaningful benefit from the iPPS treatment.
“Given these patients have a very similar treatment regimen to subjects being treated under the phase II OA randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we now look forward to the read-out of the multi-centre clinical trial.”