Paradigm Biopharmaceuticals to present at the annual JP Morgan healthcare conference next week
The company is focused on the development of a Phase 3 clinical program for its Zilosul® treatment for osteoarthritis.
Company
ASX:PAR
Paradigm Biopharmaceuticals Ltd (ASX:PAR) is a drug repurposing company driven by core competencies and experience at board and executive level in clinical and commercial pharmaceutical development. The company’s approach is to take an existing approved drug, which has demonstrated safety in its approved indications, and repurposing the drug in a new patented therapeutic application. Paradigm’s pipeline indications cover the use of pharmaceutical compound Pentosan Polysulfate Sodium (PPS), supported by full patent and IP protection and its immediate commercial focus is the repurposing of PPS for the treatment of Osteoarthritis (OA).
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The company is focused on the development of a Phase 3 clinical program for its Zilosul® treatment for osteoarthritis.
The coronavirus began the year as a mysterious virus limited to China but ended up the dominant biotech story of 2020.
The same clinical trial protocol will be used in the US, Europe and Australia, potentially enabling registrations in multiple jurisdictions, saving time and money.
The company is continuing the search for a person with extensive financial experience who will also be added to the board as an independent non-executive director.
The late-stage drug development company said the presentation would cover its proposed clinical program, safety and an update on other indications in the company’s R&D pipeline.
The trial will be Paradigm’s first in MPS-I patients and will investigate treatment in a population, including pediatric patients.
Commercial head Beverley Huttmann, chief financial officer Justin Cahill and R&D scientist Catherine Stapledon bring skills and experience that further strengthen the capabilities of management as the company moves toward commercialisation.
Pain reduction in 76 SAS patients (42 new patient data) being treated using the Phase 3 product are consistent with prior reports under TGA SAS.
The exclusive supply of Pentosan Polysulphate Sodium for 25 years following marketing approval provides a greater level of commercial protection for Paradigm as it progresses towards commercialisation of Zilosul® in Europe.
Positive feedback has been received from European Medicines Agency after Paradigm’s recent Scientific Advice meeting, a key regulatory milestone which supports and validates the company’s clinical development and commercialisation plans for
Paradigm’s investigation of PPS for MPS seeks to establish whether PPS may be an effective adjunct/combination therapy with current Enzyme Replacement Therapy treatments.
Each Patient enrolled in the program was screened to measure their baseline pain scores under the WOMAC osteoarthritis index and evaluated with MRI scans.
The company remains focused on its IND submission to the FDA for the remainder of 2020.
Dr Donna Skerrett has more than 30 years in the pharmaceutical industry and has been the company's chief medical officer since September 2019.
Paradigm is an Australian biopharmaceutical company focused on repurposing the drug pentosan polysulphate sodium (PPS) for the treatment of inflammation.
The company is preparing for phase-3 trials in both Osteoarthritis (OA) and Mucopolysaccharidosis (MPS).
The company recently reported a 45% reduction in pain across 34 patients with knee osteoarthritis (OA) using its phase 3 clinical trial product Zilosul.
Businesses are bracing for a recession but data shows pharmaceutical companies are growing due to increased demand from healthcare providers.
Earlier this month, Paradigm reported a 45% mean reduction in pain score across 34 patients with knee osteoarthritis (OA) using Zilosul.
The recent market announcements and $35 million capital raise have provided significant clarity to numerous aspects of the company’s development pathway for Zilusol.