At time of writing, the Paradigm Biopharmaceuticals Ltd [ASX:PAR] share price is up more than 4%, trading at $2.51.
The PAR share price has largely traded sideways since October:
We look at the details of their IND application to the US FDA, which according to the company keeps them ‘on track’.
Details of PAR’s announcement today
Here they are:
‘• Paradigm has made the first major submission for its Pivotal study in subjects with pain associated with Knee Osteoarthritis (OA) with the submission of its IND application to the US Food and Drug Administration (FDA).
‘• The submission of the IND within Q1 keeps the company on track to enroll clinical trial subjects on previously reported timelines.
‘• Once the IND is “Open” Paradigm may begin recruitment and screening of participants for the pivotal Para_002 study.
‘• The IND application follows a Pre – IND meeting and Type C meeting with the US FDA where the company received valuable feedback from the regulator.
‘• Following a Scientific Advice meeting with the European Medicines Agency (EMA) in September 2020, Paradigm received EMA acceptance on the company’s proposed clinical trial design.
‘• Paradigm is confident after seeking this critical feedback from both FDA and EMA, that the company will proceed with simultaneous registration for Zilosul® in multiple key regions, upon execution of a successful clinical trial program.’
The last point strikes me as the most important with regards to commercialisation of Zilosul®.
Zilosul® is injectable pentosan polysulfate for treatment of osteoarthritis and IND stands for Investigational New Drug.
Preparing the IND application was certainly labour intensive — the company notes it is more than 30,000 pages in length.
However you look at it, this application represents a milestone for the company.
According to PAR:
‘Osteoarthritis (OA) is the most common joint disorder in the United States. Symptomatic knee OA occurs in 10% men and 13% in women aged 60 years or older. The number of people affected with symptomatic OA is likely to increase due to the aging of the population and the obesity epidemic.’
So, some key demographic trends are pushing PAR along.
Outlook for the PAR Share Price
With an NPAT loss of $20 million and limited revenue against a market cap of more than $500 million at time of writing, this would concern value-oriented investors.
But numbers like this are par for the course for a biotech or pharmaceutical company.
Its current market cap speaks to the enthusiasm investors have for a novel treatment in this area of medicine.
Given that the PAR share price is largely range bound since October, this strikes me as a classic biotech/pharma movement as investors wait on bigger news.
Success of failure on trails could generate a big move either up or down.
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For Money Morning