Reistone Biopharma Announces Positive Topline Results from Phase 2 Clinical Trial Evaluating SHR0302, a JAK1 Inhibitor for the Treatment of Moderate-to-Severe Atopic Dermatitis

• SHR0302 monotherapy achieved positive results on reaching primary endpoints with statistical significance, delivering significant improvements in skin clearance
• Both doses were shown to be superior to placebo for key secondary endpoints
• AEs were manageable and generally transient and reversible
• Efficacy and safety profile support continued advancement in moderate-to-severe atopic dermatitis, with Phase 3 initiation anticipated in early 2021

SHANGHAI, Oct. 26, 2020 /PRNewswire/ -- Reistone Biopharma Co. Ltd. ("Reistone"), an innovative clinical stage biopharmaceutical company focused on developing novel medicines for immuno-inflammatory diseases with high unmet medical needs, today announced that SHR0302, a selective JAK1 inhibitor, met both the primary and secondary endpoints in its Phase 2 Study (QUARTZ2) for the treatment of moderate-to-severe atopic dermatitis (AD). All doses of SHR0302 demonstrated significantly superior response in its primary endpoint measured by the Investigator Global Assessment (IGA) Score and in the secondary endpoint of at least a 75% improvement in the Eczema Area Severity Index (EASI75) compared to placebo at week 12.

QUARTZ2 study investigated the efficacy and safety of SHR0302 monotherapies of 8 mg or 4 mg once-daily compared to placebo in 105 adults with moderate-to-severe AD and has demonstrated significant improvement in skin clearance. On the primary endpoint assessed at week 12, SHR0302 8 mg achieved an IGA score of "clear" and "almost clear" of  54.3% compared to 5.7% for placebo (p<0.001), while 4 mg SHR0302 achieved an IGA success rate of 25.7% (p=0.022). In addition, SHR0302 achieved statistically significant differences compared to placebo in its key secondary efficacy endpoints for EASI75 (8 mg, 74.3% vs placebo, 22.9%, p<0.001; 4 mg, 51.4% vs placebo, p=0.013). QUARTZ2 study has also demonstrated significant improvement in itch symptoms scores, a major complaint that affects patients' quality of life. Itch symptoms were measured using the Pruritus Numerical Rating Scale (NRS) with a reduction =>3 defined as a clinically meaningful change. The percentage of subjects that experienced statistically significant and clinical meaningful improvement in itch symptoms after 1 week of treatment with 8 mg was 60.0%, compared to placebo, 8.6% (p<0.001), and 42.9% (p=0.001) for 4 mg, showing that oral SHR0302 has a fast onset mode of action for AD.  

Safety results showed that both doses of SHR0302 were very well-tolerated, with most adverse events (AEs) characterized as mild and treatment emergent adverse events (TEAEs) were broadly similar between the active treatments and placebo. Three severe adverse events (SAEs) were reported and were deemed unrelated to active treatment. There was no AE of malignancy, death, pulmonary embolism (PE) or deep vein thrombosis (DVT) in this study. The safety results are consistent with the selectivity of JAK1 inhibitor, showing that SHR0302 may exhibit a better safety profile compared to pan-JAK inhibitors.

"We are very pleased with the results of this Phase 2 study, which underscores our belief in the potential for SHR0302 to provide a better solution for patients with moderate-to-severe atopic dermatitis," said Min Irwin, Co-founder, and CEO of Reistone. "These results bring into focus the exciting opportunity for SHR0302, with the possibility to improve immuno-related skin diseases and serious immuno-inflammatory diseases, for an area with high unmet needs for new treatment options. Reistone will soon initiate its phase 3 clinical trial in atopic dermatitis indication. We look forward to building on the insights from this study and SHR0302 to drive the path forward for the company, the target molecules, and patients in need beyond our planned clinical studies and current pipeline."

"Many of our patients with moderate-to-severe atopic dermatitis have persistent challenges managing their condition, which has profound impacts on their quality of lives," said Professor Jianzhong Zhang, Peking University People's Hospital, leading principal investigator of this trial. "We are very excited to learn of the positive results. Apart from meeting its pre-defined endpoints, I am particularly impressed with the itch symptom improvement by week 1, which will truly benefit the patients. The data is compelling and demonstrates clinically, SHR0302, a selective Janus kinase 1 (JAK1) inhibitor, has great potential to be an important treatment choice for patients."

QUARTZ2 (NCT04162899) was a randomized, double-blinded, placebo-controlled study conducted across 23 Chinese sites, evaluating the efficacy, safety, and tolerability of SHR0302 in adult subjects with moderate-to-severe atopic dermatitis. Eligible patients were randomized into two oral doses of SHR0302 (8 mg or 4 mg) or placebo once daily and treated for 12 weeks. The primary endpoint was defined as the percentage of subjects achieving Investigator's Global Assessment Score (IGA) 0/1 with an improvement >= 2 from baseline at week 12.

The detailed analysis of the study data is currently being conducted and will be released subsequently.

About SHR0302

SHR0302 is a potent and highly selective Janus kinase type 1 (JAK1) inhibitor and was in-licensed by Reistone from Jiangsu Hengrui Medicine Co., Ltd. Several late stage clinical studies are on-going with both oral and topical dosage forms for several immune-inflammatory diseases including Ulcerative Colitis, Crohn's disease, etc. The high selectivity of SHR0302 may potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitors.

Atopic Dermatitis (AD)

Atopic Dermatitis (AD) is a chronic inflammatory skin disease that poses a significant burden on not only patients' quality of life but also the health care system. It is a complex disease with a wide spectrum of clinical presentations and combinations of symptoms, including patches of skin that are red or brownish, dry, cracked, or skin that is scaly and itchy, especially at night. AD affects up to 20% of children and up to 3% of adult; recent data has shown that the prevalence in both children and adults is increasing, especially in low income countries. While biologics are an important addition to the treatment landscape, there remains a great need for innovative, easily manageable and affordable therapies for AD patients.

About Reistone

Reistone Biopharma Co. Ltd. is a clinical stage biopharmaceutical company with a pipeline of immunology therapies focused on developing novel medicines aimed at treating autoimmune and inflammatory diseases that have high unmet needs. The company was founded in January 2018 and is headquartered in Shanghai, China with additional operations in Beijing, China, and Chicago and Boston, United States. It currently employs about 130 people in China and the United States. Further information about the company and its drug development programs and capabilities may be found online at http://www.reistonebio.com

Contact Information

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SOURCE Reistone Biopharma

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