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.

Reistone Biopharma’s SHR0302 ointment performed well in a Phase 2 study of patients with mild-to-moderate atopic dermatitis (AD), the company reports.

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

All three doses (0.5%, 1%, 2%) met the primary endpoint, demonstrating significantly improved percentage change of Eczema Area and Severity Index (EASI) score 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.

The new topical formulation may provide strong synergies to oral SHR0302, which is currently in Phase III trials for moderate to severe AD patients. Oral SHR0302 was granted Breakthrough Therapy designation by China's CDE for treatment in atopic dermatitis in January 2021.

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," says Dr. Jinhua Xu, chief of dermatology at Huashan Hospital in Shanghai, China, in a news release. "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," says 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.