The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is running higher today after the company announced key clinical trial approvals in Brazil.
The Paradigm share price is currently up 5.5%, trading at $2.10.
Paradigm is currently focused on repurposing pentosan polysulfate sodium (PSS) to treat a range of chronic diseases including osteoarthritis, bone marrow lesions and chronic heart failure.
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Clinical trial highlights
In today's statement, Paradigm has received approval from Brazil's National Health Surveillance Agency for a Phase 2 clinical trial to evaluate the safety of injectable PSS in subjects with Mucopolysaccharidosis type VI (MPS VI).
Paradigm also received an ethics approval from Brazil's National Research Ethics Commission to conduct the Phase 2 clinical trial.
Also known as Maroteaux-Lamy syndrome, MPS VI is a progressive genetic condition that causes tissues and organs to enlarge and become inflamed or scarred. Brazil has the highest concentration of MPS-VI sufferers globally, according to the company.
The company's primary objective in the Phase 2 trial is to evaluate the safety and tolerability of PPS in subjects with MPS VI across 6, 12 and 24 week time frames. It will recruit 12 participants, with 8 subjects receiving PPS treatment and four receiving a placebo.
The company will also assess a number of secondary and exploratory endpoints, including pain and mobility, walking-related plan and quality of life.
What did management say?
Paradigm CEO Paul Rennie said:
We are delighted to achieve this regulatory milestone during a busy period with the IND application process with the US FDA for our lead indication in osteoarthritis.
Paradigm will be monitoring the current COVID situation in Brazil to plan the trial commencement and will update the market once a timeline is determined.
Paradigm share price struggles post-COVID
The company's shares made a meteoric rise from $1.36 to highs of $4.50 between late August 2019 and early February 2020, just before COVID-19 hit.
But after the initial March 2020 selloff, Paradigm shares haven't quite been the same.
The Paradigm share price has slipped 15% year-to-date and is down about 50% from its pre-COVID highs.
