As it advances its injectable Pentosan Polysulfate (iPPS) drug towards commercialisation, Paradigm Biopharmaceuticals (ASX: PAR) has noted a clinically meaningful decrease in bone marrow lesions in hip, knee caps and ankles for patients enrolled in the company’s phase 2b clinical trial.
Under the Therapeutic Goods Administration’s special access scheme, patients who have received iPPS injections have reported reduced bone marrow lesions in other sites of the body other than the knee, which has been the primary focus of clinical trials.
The decrease in bone marrow lesions was also accompanied by lower pain scores across these sites.
“While the company is focused on the treatment of osteoarthritis of the knee for its upcoming phase 3 trial, this is further real-world evidence of iPPS potential for treatment on all sites of the body effected by bone marrow lesions,” Paradigm stated.
Additionally, Paradigm is also looking at “whole of body” impact from iPPS – where a patient has been treated with the drug at one site such as the knee but has also experienced relief in other sites like hands or back.
Paradigm has now completed manufacturing iPPS for its upcoming phase 3 osteoarthritis and mucopolysaccharidosis (MPS) trials to meet TGA special access and Food and Drug Administration compassionate use requirements.
The company plans to lodge its FDA compassionate use application in the coming weeks. If the application is successful, Paradigm will be able to treat up to 50 past NFL football players in the US with its iPPS.
In readiness of approvals, Paradigm has 10 NFL players who have already agreed to be treated with first results anticipated later this year.
To fund the clinical trials and advancing iPPS, Paradigm has completed a $77.9 million capital raising.
Meanwhile, Paradigm has also reported its main competitor’s drug for treating osteoarthritis Pfizer and Lilly’s Tanezumab has failed the phase 3 trial, with results revealing neither dosage level met all co-primary efficacy goals and both doses faring worse than the placebo on safety.
By mid-morning, shares in Paradigm had lifted almost 2% to $1.56.