Friday, September 08, 2023 7:46:28 AM
All study objectives were met, demonstrating safety across dose groups and confirming efficacy and durability at the selected doses against placebo (lidocaine) and active control (steroid).
All RTX doses (7.5 to 20 µg) were well-tolerated, with few severe or serious adverse events (AEs). The majority of reported AEs related to pain post-administration and resolved within hours following treatment. Very few severe AEs were reported across groups (including placebo) with no dose correlation. RTX post-injection administration pain was easily controlled.
RTX 20mcg dose outperformed all other dose groups (including the approved drug for this indication (intra-articular corticosteroids)) for efficacy and durability at and beyond 26 weeks post-treatment. RTX 20mcg and 12.5mcg have been selected as the clinically optimal and minimally effective doses for further phase 2 pivotal or phase 3 trials.?
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