Paradigm Biopharmaceuticals (ASX:PAR) has had the preclinical study validating the efficacy of its drug, pentosan polysulfate sodium (PPS), published in a peer-reviewed scientific journal.
The study validated the efficacy of PPS as a non-steroidal agent in allergic rhinitis, also known as hay fever and was published by the journal named Immunity, Inflammation and Disease.
PPS is a new, multi-acting treatment for hay fever, bone bruising and viral arthritis, all of which have very large addressable markets estimated at US$14+ billion.
Paradigm’s PPS-based nasal product, Rhinosul® has the potential to be the first-in-class, non-steroidal intranasal spray to treat the early and late phases of hay fever.
Paul Rennie, CEO, commented:
“The novelty of Paradigm’s Rhinosul, in comparison to current allergic rhinitis medications on the market, is its dual action.
“Rhinosul has both mast cell stabilising activity, which controls histamine release and anti-inflammatory properties in a single pharmaceutical product.
“This suggests that Rhinosul has the potential to be the first-in-class dual acting non-steroidal intranasal spray to treat hay fever.
“This peer-reviewed publication provided the basis for Paradigm’s clinical development program to assess its PPS based nasal product, Rhinosul, in a Phase 2a clinical trial.”
Addressable market
The current market for allergic rhinitis is about US$11 billion and is dominated by anti-histamines and corticosteroids with market surveys highlighting patient dissatisfaction and the need for effective therapy.
Rhinosul has unique properties consisting of both histamine stabilising and anti-inflammatory properties without the known side effects of antihistamines and steroids.
The company believes its product can meet market needs that are not effectively managed by current nasal sprays.
Next steps
The Phase 2a study is a double blind, placebo controlled, cross-over allergen challenge study treating subjects with hay fever and is being conducted under the leadership of Dr Lennart Greiff at Skane University Hospital in Sweden.
Dr Greiff has previously conducted similar clinical trials, using the established allergen challenge clinical model for hay fever, for major international pharmaceutical companies.
The last clinical participant out of the trial occurred in March 2017 and data analysis has commenced with the read-out from the clinical trial expected at the end of June 2017.