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Paradigm Biopharmaceuticals prepares for “pivotal” phase three clinical trial over FY21

Published: 13:11 27 Aug 2021 AEST

Paradigm Biopharmaceuticals Ltd - Paradigm Biopharmaceuticals prepares for “pivotal” phase three clinical trial over FY21

Paradigm Biopharmaceuticals Ltd (ASX:PAR) has tabled its FY21 report, reflecting on regulatory and commercial achievements as it works to develop an analgesic for the most common form of arthritis.

The health stock, which is focused on commercially repurposing drugs in a new, patented therapeutic application, is working to translate a historic candidate known as pentosan polysulfate sodium (PPS) or Zilosul® into a treatment for osteoarthritis pain.

Over FY21, the ASX-lister submitted an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for Zilosil and is working to commence a global phase three trial with the candidate before year’s end.

Looking ahead, Paradigm remains committed to advancing its osteoarthritis clinical program and other pipeline indications in a bid to bring PPS to the market and help improve pain and mobility in millions of people who suffer from joint stiffness.

The company’s regulatory and commercial push comes as the number of people impacted by osteoarthritis is set to increase by two-thirds between 2020 and 2030.

Investing in clinical development

Commenting on the company’s progress to date, Paradigm interim chair and CEO Paul Rennie said: “Much of the investment in FY21 was focused on identifying and then meeting the requirements of the regulatory pathways for clinical development for the lead programs.

“Infrastructure and organisational support were strengthened for current and upcoming clinical trial activities.

“We engaged key opinion leaders and industry experts to work alongside our in-house teams to enhance success in advancing the programs.

“Investment will continue as we progress with both the global clinical pivotal program and projects to optimise commercial and partnering attractiveness for Zilosul®.”

In his CEO report, Rennie continued: “The achievements of FY21 are important in our journey as a company and help set a strong foundation for Paradigm to grow.

“There have been many achievements during FY21, and we look forward to continuing to achieve significant progress over the next 18 to 24 months, a pivotal period for Paradigm.”

Where Zilosul® can fit in the treatment process.

Financials

PAR brought in $20,550 — its first company revenue — from its operations over FY21, as well as roughly $8.9 million in other income.

The biopharma stock tabled a $34.3 million loss over the 2021 financial year, up from the previous year’s $12.3 million dip into the red because of a considerable increase in research and development (R&D) spending.

Paradigm expensed roughly $33.5 million on R&D activities over the period — more than double the $14 million recorded over FY20.

The ASX-lister kicked off the financial year with more than $103.9 million in the bank and ended the period with $71 million to continue operations.

Drive towards commercialisation

Over the 2021 financial year, Paradigm hit several milestones as it worked to build its organisation and support Zilosil®’s development.

In January this year, the biotech underwent a rebrand at the JP Morgan Healthcare Conference, emphasising its repurposing mission when it comes to treatment candidates.

The ASX-lister also incorporated a US entity to back the candidate’s clinical program, with chief medical officer Dr Donna Skerrett appointed to lead the branch’s clinical team.

As it prepared for the phase three trial, Paradigm worked to evolve its commercial function and conducted 26 pre-clinical trials centred on injectable PPS.

The company recorded its first revenue from Zilosul® sales over the financial year by implementing the pay-for-use provision via the Therapeutic Good Administration’s (TGA) Special Access Scheme (SAS).

At present, product sales are expected to be modest because Paradigm is rationing the product available for the SAS to prioritise supply for its pivotal clinical trial program.

However, the SAS does provide an option for patients who are not eligible to participate in Paradigm’s clinical trials to access therapy under the guidance of their physician.

Investigating PPS’ efficacy

In terms of regulatory activities, the biotech submitted its IND application with the US FDA and secured ethics approval for the upcoming phase three trial, which is set to kick off next quarter.

Paradigm also achieved Orphan Drug indication from Brazil’s National Health Surveillance Agency and ethics approval for a phase two trial.

This will investigate PPS’s safety and tolerability compared with a placebo in patients with Mucopolysaccharidosis (MPS) type VI, a progressive condition that causes many tissues and organs to enlarge, become inflamed or scarred, and eventually waste away.

The phase two study will be the largest clinical trial using PPS in patients with MPS, while a study with MSP I patients in Australia has also been initiated.

Paradigm’s MPS program has received Orphan Drug Designation status in the US and European Union for MPS I and MPS VI.

The company has also made preclinical progress with PPS in two new indications, heart failure and acute respiratory distress syndrome (ARDS). Topline results from that research are expected in 2021’s final quarter.

It brings the number of potential PPS indications currently being explored for development to seven.

Looking ahead

Fresh board appointments in FY21 prepared Paradigm for the new financial year, with Helen Fisher and Amos Meltzer joining as non-executive directors and Dr Donna Skerrett appointed as to an executive director role.

The company said Fisher, previously a tax partner at Deloitte; Meltzer who has a background in science and commercialisation and is an intellectual property lawyer; and Dr Skerrett, who has three decades of experience in clinical research and development, bring a wealth of experience to the team.

Rennie said of the new joiners: “These appointments improve the composition of the board in terms of independence, gender diversity and will contribute to the success of Paradigm into the future.”

Capping off the annual report, Rennie concluded: “We remain focused on progressing our Phase 3 osteoarthritis clinical program and other pipeline indications to bring PPS to market to improve pain and mobility for the millions of people who suffer from arthralgia driven by injury, inflammation, ageing, degenerative disease, infection, or genetic predisposition.

“In what has been at times a challenging year with the interruptions that COVID-19 has presented to all the company’s programs, I’d like to thank our dedicated staff for the progress and achievements they have made throughout FY21.

“The company is well placed to continue the development of PPS for treatment of osteoarthritis and other conditions.”

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