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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“These critical findings provide confidence in PPS as a potential world-first CHIKV therapy,” said Dr Lara Herrero.
Biotechnology companies by and large look to develop and bring to market drugs or treatments for a cavalcade of conditions, and there’s plenty to be found on the ASX.
“The achievements of FY21 are important in our journey as a company and help set a strong foundation for Paradigm to grow,” says interim chair and CEO.
Zilosul® was made available during the second quarter to physicians with SAS approval to treat patients experiencing chronic arthralgia from Ross River virus (RRV) infection.
Pentosan polysulfate sodium (PPS) is currently being evaluated by Paradigm for potential registration for the treatment of osteoarthritis and other inflammatory diseases in the US and other major global markets.
Securities will remain halted until Tuesday, August 3, 2021, or when an announcement is released to the market.
The late-stage drug development company has a mission to develop and commercialise Pentosan Polysulfate Sodium for the treatment of pain associated with musculoskeletal disorders.
This will be the largest clinical trial conducted using PPS in any MPS type subjects, and will evaluate the safety and tolerability of the drug as well as its effects on mobility, urinary GAG levels, walking-related pain, quality of life an
The company is on track to respond to questions from the US Food and Drug Administration around its Investigational New Drug application within 30 days.
Under the pay-for-use SAS program, Paradigm has already received five prescriptions for Zilosul® from physicians and the five patients will commence Zilosul® treatment in the coming week.
The FDA was unable to provide all questions within the initial IND review period and has advised it will submit further questions to Paradigm within the next 30 days.
The study will investigate changes in knee synovial fluid biomarkers associated with pain, inflammation and disease progression of knee Osteoarthritis.
Under the new agreement, both parties have agreed to jointly fund the R&D and work collaboratively on new Intellectual Property creation, which Paradigm will commercialise.
Once the IND is ‘open’, the company can begin recruitment and screening of participants for the Pivotal Para_002 clinical study – subject to institutional ethics committee approvals.
The data produced in the pilot study provide clinical evidence that PPS may offer patients a treatment option for a disease that has little or no therapeutic options for chronic RRV infection.
Paradigm is a late-stage drug development company with the mission to develop and commercialise Pentosan Polysulfate Sodium for the treatment of pain associated with musculoskeletal disorders driven by injury and inflammation.
The Phase 2 study will evaluate the treatment effect of Pentosan Polysulfate Sodium (PPS) (Zilosul®) compared with placebo on synovial fluid biomarkers in participants with knee osteoarthritis pain.
The company continues to progress toward submission of the investigational new drug for Zilosul® and is focused on implementation of the osteoarthritis clinical program to support commercialisation.
In the 89 patients treated with Zilosul®, 75.3% reported at least a 25% reduction in WOMAC pain with 56.2% of patients reporting a greater than 50% reduction, while in subjects with knee OA, it shows a very consistent reduction in pain of n
Paradigm will be focused on Phase 3 trials of its drug Zilosul® during 2021, COO Jeannie Joughin told Proactive.
