China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China.
Study Design and Patient Enrollment
The randomized, double-blind, double-simulation, three-arm, multi-center, parallel-controlled Phase III study enrolled 535 patients aged 12 and above with SAR. Participants were randomly assigned to the GSP 301 NS treatment group and two original positive control drug treatment groups, namely olopatadine nasal spray (Patanase NS) and mometasone nasal spray (Nesuna NS), in a ratio of 1:1:1. The patients underwent a 14-day treatment period, with symptom improvement scores collected for the evaluation of GSP 301 NS’s efficacy, safety, tolerability, and pharmacokinetics.
Positive Results and Clinical Significance
The results demonstrated that the GSP 301 NS group experienced a greater decrease in the average morning and afternoon total reflexive nasal symptom score (rTNSS) over a 12-hour period compared to both the Patanase NS group and the Nesuna NS group. These differences were both clinically and statistically significant, indicating that GSP 301 NS outperformed the originator drugs in terms of efficacy. Additionally, GSP 301 NS met the default clinical endpoints for safety, tolerability, and pharmacokinetic characteristics.
Global Approvals and Potential Impact
GSP301 NS, a fixed combination of olopatadine and mometasone, was first approved in the US in January 2022 and has since gained approvals in Australia, South Korea, Russia, the UK, and the EU. The success of the Phase III study in China further solidifies the drug’s potential as a treatment for SAR patients globally.-Fineline Info & Tech
