Reistone Biopharma has reported that its SHR0302 ointment met the primary goal of the Phase II MARBLE23 clinical trial in adults and adolescents with mild-to-moderate atopic dermatitis (AD).
SHR0302 is a topical, highly selective inhibitor of Janus kinase type 1 (JAK1).
The randomised, double-blinded, placebo-controlled, seamless and adaptive Phase II/III trial is designed to analyse the safety and efficacy of the SHR0302 ointment in subjects with mild-to-moderate AD.
For the Phase II part, 128 subjects were enrolled and categorised to receive twice-daily 0.5%, 1%, or 2% doses of SHR0302 ointment or placebo.
The percentage change in the Eczema Area and Severity Index (EASI) score of the treatment arms compared with placebo at week eight was the primary goal of the trial.
EASI score is a tool to assess AD extent and severity.
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Doses for the Phase III part will be selected based on safety and efficacy data from the Phase II trial.
Findings showed that all the three doses tested met the primary goal, with a substantially improved percentage change of EASI score from the baseline against placebo at week eight.
Furthermore, SHR0302 treatment offered quick itch reduction onset, offering relief to chronic and nocturnal itching patients.
The ointment was found to be well-tolerated at all dose levels tested in the trial with treatment-emergent adverse events (TEAEs) in line with the vehicle arm.
Reistone CEO and co-founder Min Irwin said: “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.”
The Phase II trial results support the planned commencement of the Phase III programme which will randomise subjects into a 2:1 ratio to give SHR0302 ointment or placebo.
The company noted that the ointment could offer robust synergies to the oral formulation of the drug, which is being analysed in Phase III trials to treat moderate-to-severe AD.
This could also aid in extending more therapy options to patients with varying disease severities.