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Paradigm Biopharmaceuticals (ASX:PAR) - Interim Chairman, Paul Rennie
Interim Chairman, Paul Rennie
Source: Paradigm Biopharmaceuticals/Twitter
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  • Paradigm Biopharmaceuticals (PAR) tables revenue of more than $8.9 million for FY21, up 90.43 per cent on the prior corresponding period (pcp)
  • Unfortunately for the company, it also experienced an increase in loss by 178.86 per cent from the pcp to $34.29 million
  • During FY21, Paradigm made great progress in support of a successful clinical program for its Zilosul product in patients with osteoarthritis
  • According to Interim Chair Paul Rennie, the company intends to begin a clinical trial for Zilosul before the end of the year
  • Paradigm was down 2.54 per cent on the market with shares trading at $1.92

Paradigm Biopharmaceuticals (PAR) has tabled revenue of more than $8.9 million for FY21, up 90.43 per cent on the prior corresponding period (pcp).

Loss totalled $34.29 million, up 178.86 per cent from the pcp.

Paradigm ended FY21 with a cash balance of just over $71 million.

Operations

During FY21, Paradigm made great progress in support of a successful clinical program for its Zilosul product in patients with osteoarthritis.

In its clinical trials to date, Zilosul has proven to have a tolerable safety profile.

It works by exerting anti-inflammatory activity to block the effects of pro-inflammatory cytokines (signalling molecules).

Paradigm is currently working with bene pharmaChem to further understand how pentosan polysulfate sodium (PPS), also known as Zilosul, works.

Osteoarthritis is the most common form of joint disease, affecting up to 16 per cent of the world’s adult population.

Currently, it has no known cure or spontaneous remission and it is often associated with irreversible structural damage.

The prevalence of osteoarthritis is expected to increase in line with the ageing population and the growing rate of obesity.

It is believed that Zilosul will be used as a second-line treatment after nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics like paracetamol.

In March, Paradigm submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for Zilosul.

According to Interim Chair Paul Rennie, there is only one question the FDA has that Paradigm needs to answer which the company states it will do so shortly.

“As at the date of this annual report the FDA has reviewed the IND submission and has one remaining question of the six that it initially raised in response to the company’s IND submission,” Mr Rennie said.

“Paradigm will respond to the FDA by the end of August 2021 and intends to commence the global pivotal trial before the end of CY2021.”

Paradigm was down 2.54 per cent on the market with shares trading at $1.92 at 3:23 pm AEST.

PAR by the numbers
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