China-based Jiangsu Hengrui Pharmceuticals (SHA: 600276) has announced positive results from the randomized, double-blind, placebo-controlled, multi-center RSJ10333 (QUARTZ3) Phase III study for SHR0302 in atopic dermatitis. The study, conducted by Hengrui’s subsidiary Reistone Biopharma Co., Ltd, has reached the pre-set primary efficacy endpoint.
Study Details
The RSJ10333 study was designed to assess the efficacy and safety of oral SHR0302 compared with a placebo in the treatment of moderate to severe atopic dermatitis (AD). The study enrolled 336 patients aged 12 years and over, who were randomly assigned to receive oral treatment of 8mg or 4mg of SHR0302 once per day or placebo. The primary endpoint was the proportion of subjects who achieved IGA 0/1 response and EASI 75 response at 16 weeks of treatment. The results showed that at the 16th week, a significantly higher proportion of patients who received SHR0302 in both dosage groups achieved IGA 0/1 response and EASI 75 response, compared with the placebo group. Additionally, SHR0302 demonstrated significantly better efficacy in improving skin itching than the placebo. No new safety signals were identified.
Market Context
SHR0302 is a highly selective Janus kinase 1 (JAK1) inhibitor. Currently, there is no homegrown JAK1 inhibitor on the market in China. Meanwhile, Pfizer’s abrocitinib and AbbVie’s upadacitinib are commercially available globally, generating respective global sales of USD 6 million and USD 1.651 billion in 2021. The positive results from the Phase III study position SHR0302 as a potential new treatment option for patients with atopic dermatitis.
Future Implications
The successful Phase III results for SHR0302 mark a significant milestone for Hengrui Pharmceuticals in its efforts to develop innovative treatments for atopic dermatitis. This move underscores the company’s commitment to addressing significant unmet medical needs and enhancing patient outcomes through advanced pharmaceutical solutions.-Fineline Info & Tech
