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Reistone Announces First Patient Dosed in Phase III Global Study in Atopic Dermatitis
SHANGHAI, May 13, 2021 /PRNewswire/ -- Reistone Biopharma Company Limited (Reistone), a clinical stage biopharmaceutical company focused on developing novel medicines for autoimmune and inflammatory diseases, today announced the first patient has been dosed in their Phase III, global clinical trial (RSJ10333) of SHR0302, a potent and highly selective small molecule inhibitor of Janus kinase type 1 (JAK1) in patients with moderate-to-severe Atopic Dermatitis (AD). The trial is being conducted in Canada and China. The first patients enrolled were from Canada.
RSJ10333 is a randomized, double-blinded, placebo-controlled study to evaluate efficacy and safety of oral SHR0302 in subjects aged 12 years and older with moderate to severe AD. A total of 330 adolescent and adult subjects will be enrolled and treated with 4 mg or 8 mg SHR0302, or Placebo for up to 52 weeks. Subjects taking the placebo will be re-randomized to active treatment (4 mg or 8 mg SHR0302) after the completion of 16 weeks of treatment.
The Phase III program is based on positive results in a Phase II study in patients with moderate to severe AD, in which both doses of SHR0302 showed significant improvement in reducing symptoms and lesion clearance compared to placebo. The results of the Phase II study were presented as a late breaking abstract in this year's AAD VMX meeting, held on Apr. 23 to 25, 2021.
Atopic Dermatitis is a common chronic inflammatory skin disease characterized by recurrent attacks, pleomorphic skin lesions, dry skin, and severe pruritus. The pathogenesis of AD is mainly related to genetic background, environmental stimuli, epidermal barrier defects and immune disorders. Disruption of the epidermal barrier in AD patients stimulates an inflammatory response leading to Th2 cell activation and mast cells and basophils degranulation. The JAK-STAT pathway plays an important role in immune dysregulation in AD, therefore, blocking the JAK-STAT pathway using JAK inhibitors can inhibit the pathophysiological process of AD. Globally, the prevalence of AD ranges from 10% to 20% in children and 2% to 8% in adults, with moderate-to-severe patients accounting for 20% of the cases. Unfortunately, there are a limited number of treatments available for AD. Unmet needs remain high for AD treatment with a growing clinical evidence proving that JAK inhibitors are potential treatments.
"One of the most common treatments for AD are corticosteroids, however, corticosteroid use is limited to 2 to 4 weeks due to side effects and mid-to-high potency corticosteroids are not approved for use on the face and/or intertriginous areas, leaving many patients looking for other treatment options," stated Dr. Min Irwin, Chief Executive Officer of Reistone, "We are very excited about the study and dosing the first subject, which represents another key milestone for Reistone as it marks the first phase III program in dermatology therapy area for this compound."
Aik Han Goh, M.D., Chief Medical Officer of Reistone, noted, "Given that JAK-STAT pathway plays an important role in Th2 cell mediated Atopic Dermatitis pathogenesis, SHR0302, an oral JAK inhibitor has great potential to be an alternative treatment for Atopic Dermatitis. The impact of Atopic Dermatitis goes far beyond skin lesions and pruritus. It causes not only physical, but emotional and social discomfort, including social isolation, embarrassment, and in severe cases leads to anxiety and depression. We are devoted to improving the quality of life in patients with Atopic Dermatitis."
For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT04875169
SHR0302 is a novel, potent, orally administered selective Janus kinase type 1 (JAK1) inhibitor in development as a treatment for various autoimmune and inflammatory diseases. JAK1 selectivity could potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitor. Longer-term clinical studies are ongoing to confirm a favorable risk-benefit of JAK1 selectivity by avoiding the hematological side effects related to JAK2 inhibition. Reistone licensed in the drug from Jiangsu Hengrui Medicine Co., Ltd and owns the global rights for multiple indications of autoimmune diseases.
Reistone Biopharma Company Limited (Reistone) 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, including Alopecia Areata, Atopic Dermatitis, Ulcerative Colitis and Crohn's disease. The company was founded in January 2018 and operates in Shanghai and Beijing, China, as well, Chicago and Boston, the United States. Reistone in-licensed 4 assets from Hengrui Medicine Co., Ltd and from there built a sequential pipeline containing both late-stage and early development programs, currently running 2 Phase III, 5 phase II studies and 2 phase I studies globally.
Aik Han Goh
Chief Medical Officer
Senior Vice President
US Site Head and Head of International Development