- SHR0302 ointment, a topical, selective JAK1 inhibitor, met key primary and secondary endpoints, demonstrating significant improvement in percent change of EASI score from baseline and fast onset of itch reduction compared to placebo
- Results from phase II supports planned initiation of phase III program
SHANGHAI, Oct. 11, 2021 /PRNewswire/ -- Reistone Biopharma ("Reistone"), a leading biotech focused on development of treatments for immune and inflammation related diseases, today announced positive results from a Phase II study evaluating the safety and efficacy of twice daily SHR0302 ointment in adults and adolescents with mild-to-moderate atopic dermatitis (AD). All three doses (0.5%, 1%, 2%) met the primary endpoint, demonstrating significantly improved percentage change of Eczema Area and Severity Index (EASI) score, a tool used to measure extent and severity of AD, from baseline versus placebo at week 8. In addition, treatment with SHR0302 ointment provided rapid onset of itch reduction, providing relief for patients with chronic and nocturnal itching. Approximately 80 percent of AD patients have mild or moderate form of the disease but do not have satisfactory control of the disease from current treatment options. The new topical formulation may provide strong synergies to oral SHR0302, which is currently in Phase III trials for moderate-to-severe AD patients, and thus providing treatment options for patients suffering from all severities of AD.
Atopic Dermatitis (AD) is a common chronic inflammatory skin disease characterized by recurrent attacks, pleomorphic skin lesions, dry skin and severe pruritus (chronic itchy skin). People living with AD report intense, persistent itch that can be severe enough to impact sleep, daily activities, and social relationships. Approximately 16.5 million adults and 9.6 million children under the age of 18 live with AD in the U.S. and approximately 10 million people live with AD in China. Recent data show that the global prevalence of AD has been increasing, especially in low-income countries. While biologics and other oral drugs are being developed for moderate-to-severe patients, a topical treatment will be an important addition to the treatment landscape by providing an easy, manageable, and affordable option for AD patients who are candidates for topical therapy.
SHR0302 ointment was generally well-tolerated at all doses with treatment emergent adverse events (TEAEs) comparable to the vehicle group.
"There continues to be an urgent need for new and safe therapeutic options for patients suffering from atopic dermatitis as it is a chronic disease," said Jinhua Xu, Huashan Hospital. "Although topical corticosteroids are often used for initial treatment, they are associated with a number of side effects that limit their utility for long-term use. SHR0302 ointment has the potential to fulfill this unmet need."
"We are pleased to see the positive results from this study of a new topical therapy," said Min Irwin, CEO and Co-Founder of Reistone. "We believe this topical formulation will be an invaluable addition to the SHR0302 portfolio with potential to help bring a convenient and affordable treatment option to patients suffering from all severities of atopic dermatitis."
MARBLE23 (NCT04717310) is a double-blinded, randomized, placebo-controlled, seamless and adaptive-designed Phase II/III program designed to evaluate the safety and efficacy of SHR0302 ointment in adult and adolescent patients living with mild-to-moderate AD. In Phase II segment, 128 patients were randomized to one of three doses of SHR0302 ointment (0.5%, 1%, 2%) or the placebo group. The primary outcome measure assessed the percentage change in EASI score of the treatment groups versus placebo at week 8. In Phase III segment of the program, Reistone intends to select a dose based on safety and efficacy from the Phase II evaluation and randomize participants in a 2:1 ratio to receive SHR0302 ointment or placebo.
SHR0302 is a potent and highly selective Janus kinase type 1 (JAK1) inhibitor. Several late-stage clinical studies are on-going with both oral and topical dosage forms for several immune-inflammatory diseases including atopic dermatitis, vitiligo, ulcerative colitis, and Crohn's disease. The high selectivity of SHR0302 may potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitors. Oral SHR0302 was granted Breakthrough Therapy designation by China's CDE for treatment in atopic dermatitis in January 2021.
About Reistone Biopharma
Reistone Biopharma Co. Ltd. is a leading biopharmaceutical company 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 180 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