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”.
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.