The primary endpoints were total nasal symptom score and peak nasal respiratory flow using the current nasal formulation.
The company anticipates receiving the final report shortly.
The Phase 2a trial investigated the intra-nasal effect of pentosan polysulfate sodium (PPS) on postchallenge nasal symptoms using the allergen challenge model in subjects with seasonal allergic rhinitis.
Paul Rennie, CEO, commented:
“Whilst this is an unexpected outcome, it should be noted that Paradigm conducted the Phase 2a clinical trial to the highest possible quality standards and was professionally executed on budget and on time.
“As part of the protocol, extensive clinical and laboratory data was collected and the analysis of this data will provide valuable insights into the effects of PPS and guide our future directions.
“In the coming weeks, Paradigm will receive the final report and the drug master file, allowing for an independent expert to conduct an in-depth investigation, in order to determine the next steps for our allergic rhinitis program.
“Early indications suggest that the formulation used in the allergic rhinitis clinical trial may need to be optimised.”
Other PPS-related programs on track
It is important to note that Paradigm’s other programs are proceeding as planned.
The Phase 2a bone marrow lesion clinical trial continues to recruit and is scheduled to read-out in the September quarter of 2017.
The Phase 2a Ross River clinical trial has received ethics approval and is scheduled to enrol its first subjects in the September quarter of 2017.
In addition, the upcoming peer-reviewed publication of a TGA SAS case-study demonstrating PPS’s clinical effect in osteoarthritis associated with bone marrow edema is due in the September quarter of 2017.