Paradigm’s injectable osteoarthritis drug trial shows major reduction in chronic pain

Australian biotech company Paradigm Pharmaceuticals (ASX: PAR) has reported an average 51.2% reduction in chronic knee pain by a group of osteoarthritis patients being treated with its injectable Pentosan Polysulfate Sodium (iPPS) drug.

The group of 20 patients have continued the trend in pain reduction experienced by the remaining 125 other patients who also used the drug via the US Therapeutic Goods Administration Special Access Scheme (TGS SAS).

The trial group – split into six smaller groups treated from October 2017 to September 2018 – included 76 males and 69 females with a median age of 57.4 years who had been clinically-diagnosed with osteoarthritis and subchondral bone marrow edema lesions as determined by magnetic resonance imaging.

Trial pre-requisites

To qualify for the trial, patients were required to have experienced symptoms of osteoarthritic pain for at least six months prior to the commencement of treatment with iPPS, which had not been adequately addressed by standard care such as analgesic, non-steroid anti-inflammatory drugs or corticosteroids.

Of the patients with BMEL, 70% had moderate to severe cases with sizes ranging up to more than 20 millimetres in diameter, and 30% had lesions less than 5mm in diameter.

Patients were administered with two injections of iPPS per week for three to six weeks depending on the severity of their BMEL, with a total of up to 12 injections allowed.

At the conclusion of the self-reporting trial, 126 patients (86.8%) responded with a reduction in joint pain and 132 (91.0%) showed an improvement in knee function.

The positive outcome precedes results from a 110-patient Phase 2b randomised, double-blind, placebo-controlled, multicentre, clinical trial using iPPS for patients with knee osteoarthritis and concurrent bone marrow lesions.

Those results are expected by year end.

PPS availability

Having been used in humans for more than 60 years, PPS is a semi-synthetic complex carbohydrate manufactured from European beech xylans and is well tolerated by the body.

The oral formulation of the drug is FDA-approved and used for the treatment of interstitial cystitis (or painful bladder syndrome) and deep vein thrombosis.

PPS in injectable form is used in Europe for prevention of thrombo-embolisms and acute blood vessel occlusions in humans.

Injectable PPS has not yet been approved for use in Australia however Paradigm has been granted patents to use it for new indications.

Sports treatment

Past and present elite athletes have been treated by their doctors with iPPS via the TGA SAS for osteoarthritis and acute injuries, with concurrent bone marrow lesions.

A growing number of club doctors from a variety of elite Australian sporting codes have also successfully treated their players.

In October, Paradigm announced it had entered into a Heads of Agreement with a US-based retired professional sporting network organisation to identify and assist sportspeople with with existing knee and joint pathologies.

At mid-afternoon, shares in Paradigm Biopharmaceuticals were up 4.71% to $1.000.