Accropeutics’ drug has hit the goals of a phase 2 psoriasis trial in China, prompting the biotech to pledge to “accelerate” the TYK2/JAK1 inhibitor’s clinical development.
The study saw 145 Chinese patients with moderate to severe plaque psoriasis receive one of three doses of the drug, dubbed AC-201, or placebo. All three of the dose cohorts hit the trial’s primary endpoint as measured by the proportion of patients achieving a 75% improvement on the Psoriasis Area and Severity Score (PASI 75) at Week 12 compared to placebo.
Specifically, the PASI-75 response rate was 31.4% for the 25-mg twice-daily dose cohort, 74.3% for those receiving a 50-mg dose twice a day and and 59.5% for the 100-mg daily dose group, compared to 8.1% for the placebo cohort.
For comparison, Bristol Myers Squibb’s TYK2 inhibitor Sotyktu, which was approved for psoriasis in 2022, triggered 75% or greater improvements in psoriasis area and severity in 53% and 58% of patients in a pair of 16-week phase 3 clinical trials.
Meanwhile, Accropeutics’ AC-201 also hit its secondary endpoint across all three cohorts as measured by PASI 90, with the greatest effect being 48.6% for the 50-mg cohort, the biotech said in a post-market release May 20.
AC-201 was well tolerated, according to Accropeutics, with no serious adverse events or other adverse events that led patients to permanently discontinue the study. The majority of treatment-emergent adverse events were mild or moderate in severity, with the most common being upper respiratory tract infection or high amounts of triglycerides in the blood.
“We are excited to see the positive results from the phase 2 study of AC-201, and we will accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases,” Accropeutics’ CEO and co-founder Xiaohu Zhang, Ph.D., said in the release.
AC-201 is Accropeutics’ most advanced asset. In March, the company secured $12 million in series B funds that was earmarked to continue the clinical development of its RIPK2 inhibitor AC-101, which is currently undergoing a phase 1b trial for ulcerative colitis.
The biotech’s other clinical-stage candidate is a RIPK1 inhibitor dubbed AC-003, which is now being evaluated in a phase 1b trial for the treatment of acute graft-versus-host disease.
Roivant has its own TYK2/JAK1 inhibitor in development in the form of brepocitinib, which the biopharma licensed from Pfizer back in 2022. While Roivant dropped development of brepocitinib in lupus after a phase 2 fail, the company is still evaluating the drug in non-infectious uveitis and dermatomyositis.