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Paradigm Biopharmaceuticals finalises Ross River virus trial recruitment

Shares in the company have more than tripled over the past 12 months.

folder titled clinical trial with stethoscope on top
Results from this phase IIa study are due late in the December quarter

Paradigm Biopharmaceuticals Ltd (ASX:PAR) has finalised the recruitment of its phase IIa clinical trial in participants with persistent Ross River virus (RRV) induced arthralgia (painful joints).

Subjects of the randomised, double-blinded placebo-controlled pilot clinical trial will be treated with injectable pentosan polysulfate sodium (iPPS).

Results from this phase IIa study are due to be reported by late in the December quarter of this year.

Paradigm’s CEO Paul Rennie said: “Strategically, this pilot study is aimed at providing the clinical evidence for the design of a larger clinical trial in Chikungunya Virus (CHIKV) induced arthralgia”.

READ: Paradigm Biopharmaceuticals new data shows 60% pain reduction, shares rise

CHIKV is closely related to the Ross River virus, both of the alphavirus genera.

Causing more than three million infections worldwide, CHIKV outbreaks have been reported in parts of Africa, Europe, Southeast Asia, and islands in the Indian and Pacific Oceans.

In 2013, CHIKV was found for the first time in the Americas and has spread to the Caribbean, South and Central America and North America.

No treatments present commercial opportunity

The expanding incidence and the lack of anti-viral agents, vaccines or effective pharmaceutical agents to treat CHIKV make iPPS a valuable product for this unmet medical need.

Similarly, there are currently no registered therapeutics to treat the ten thousand cases of Ross River infections in Australia each year.

Ross River recruitment capped at 20

Paradigm has decided to cap recruitment at 20 instead of 24 participants due to the significantly lower RRV incidence in 2018 compared to the 2017 outbreak.

Paradigm’s key objective of safety in the target population with RRV-induced arthralgia is expected to be met despite the shortfall of 4 participants.

Quick facts: Paradigm Biopharmaceuticals Ltd

Price: 3.16 AUD

ASX:PAR
Market: ASX
Market Cap: $710.2 m
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