Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb) candidate for chronic sinusitis with nasal polyps (CRSwNP), has met its primary endpoint. The study demonstrated the efficacy and safety of SSGJ-611 in treating CRSwNP, a condition affecting an estimated 28 million to 35 million people in China.
The trial’s results indicated that both dose groups of SSGJ-611 (300mg every two weeks, 450mg every four weeks) exhibited a rapid onset of action and showed a trend of response differences compared to the placebo group from the fourth week of administration. The primary endpoint indicators, including the bilateral endoscopic nasal polyp score (NPS) and weekly average nasal congestion score (NCS), were significantly better in the treatment groups than in the placebo group, with statistically significant differences (P values < 0.05 for both). At week 16, the NPS scores for the two treatment groups showed improvements from baseline of -2.12 and -1.61, respectively, while the NCS scores showed improvements of -1.11 and -1.16, respectively. The efficacy response at week 16 was comparable to or even showed a higher trend than that of dupilumab at week 24, although this was not a head-to-head controlled study.
In terms of safety, SSGJ-611 was found to be safe and well-tolerated among CRSwNP subjects, with the majority of treatment-related adverse events being grade 1-2. Chronic sinusitis (CRS) is a prevalent condition characterized by sinus mucosa inflammation lasting more than 12 weeks and is one of the common ear, nose, and throat diseases. Current treatment recommendations for CRSwNP include glucocorticoid-centered medical treatment and functional endoscopic sinus surgery to remove lesions.- Flcube.com
