Paradigm Biopharmaceuticals has announced the completion of a Phase 1 clinical trial of its Rhinosul pentosan polysulfate sodium (PPS) nasal spray for allergic rhinitis. Paradigm said that none of the 18 healthy volunteers involved in the study experienced any significant adverse effects and that it anticipates the final report in October 2016.
The company also announced results from a 28-day toxicology study in rats “with results supporting a safety margin of up to 20 times the estimated human dose” and said that it plans to initiate a Phase 2 trial in December 2016.
Paradigm Operations Manager Claire Kaufman commented, “It’s an exciting milestone for us at Paradigm to have progressed to this point in a short time frame” and credited “a dedicated network of leading clinical, scientific, and manufacturing partners.”
The company, which was first listed on the Australian Securities Exchange (ASX) in August 2015, lists Aptar Pharma, Monash University, and Pulmatix (led by Paul Young and Daniela Traini) among its partners.
Read the Paradigm Biopharmaceuticals press release.
