Paradigm Biopharmaceuticals Ltd (ASX:PAR) has completed Phase 1 clinical trial of pentosan polysulfate sodium (PPS) for the treatment of allergic rhinitis (hay fever), without any significant safety concerns in treated participants.
The study was conducted on 18 healthy volunteers and is the first ever to evaluate the nasal route of administration for Paradigm’s PPS nasal spray, Rhinosul.
The trial follows a 28-day intra-nasal toxicology study in rats which concluded no adverse effects at any tested dose, with results supporting a safety margin of up to 20 times the estimated human dose.
PPS is a well-established mild anticoagulant and anti-inflammatory agent that has been used for over 60 years.
Paradigm is repurposing PPS for respiratory diseases including allergic rhinitis and allergic asthma, as well as for bone marrow edema lesions following traumatic injury.
Repurposing an existing drug diminishes early developmental risks associated with traditional new drug development and usually means shorter development times, lower development costs and less safety risk.
The current market for allergic rhinitis is about US$11 billion and is dominated by anti-histamines and corticosteroids, for which market surveys highlight patient dissatisfaction.
Paradigm’s PPS product could potentially meet market needs that are not effectively managed by current nasal sprays.
The final report from the Phase 1 study for Rhinosul is due in October 2016.
In the absence of any significant safety concerns in any treated participant, preparation for the Phase 2 placebo controlled study is well underway, targeting a start date in December 2016.
Paradigm is well funded with $3 million in cash as at 30 June 2016.
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