A couple days after closing a whopping $259 million series C, Alumis is back, this time with data revealing that the biotech’s lead asset ESK-001 improved skin disease psoriasis in a phase 2 study.
The allosteric tyrosine kinase 2 (TYK2) inhibitor is being evaluated for treating moderate to severe plaque psoriasis, with the new data presented March 9 during a late-breaking session at the American Academy of Dermatology Annual Meeting.
The phase 2 trial, dubbed STRIDE, enrolled 228 participants, who were randomized either to one of five ESK-001 dose groups or to a placebo arm.
STRIDE met its primary endpoint, which was the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) at week 12 compared to placebo. At the highest dose—40 mg twice daily—64.1% of patients achieved a 75% improvement, 38.5% of patients hit 90% and 15.4% achieved 100% on the PASI scale. All measures were statistically significant.
ESK-001 treatment response kept improving over time, with maximum efficacy reached “at week 24 and beyond,” Alumis said in the March 9 data release.
The TYK2 inhibitor was generally well tolerated at all dose levels. The incidence of treatment-related adverse events was similar between ESK-001 and placebo, with most events mild or moderate in severity.
“The phase 2 clinical program was designed to evaluate the effect of different degrees of target inhibition on safety and clinical efficacy in psoriasis. We were pleased to see that ESK-001 was able to maximally inhibit the target safely, and this translated to a high degree of clinical improvement at week 12 that continued to increase over time,” Alumis Chief Medical Officer Jörn Drappa, M.D., Ph.D., said in the March 9 release. “These highly promising data support the potential for a best-in-class profile of ESK-001 in psoriasis."
The data compares to Sotyktu (deucravacitinib), Bristol Myers Squibb’s oral allosteric TYK2 inhibitor that was approved by the FDA in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis.
The approval was based on two separate trials assessing the BMS drug at 6 mg once daily, POETYK-PSO-1 and POETYK PSO-2. At week 16, 58.7% and 53.6% of patients on Sotyktu achieved a PASI 75 response in the respective trials. At week 24, 69% and 58% of patients on the BMS med achieved a PASI 75 response, respectively.
"We believe ESK-001 has the potential to be a best in class oral TYK2 inhibitor and our open label extension study data showing 80-90% PASI 75 suggests its ability to achieve biologic-like efficacy with a favorable safety profile which could potentially set a new bar for oral therapies in psoriasis," Alumis President and CEO Martin Babler told Fierce Biotech in an emailed statement. "Given that all currently used psoriasis therapies show their maximal clinical effect at 24 weeks and beyond, meeting the primary and secondary endpoints of the STRIDE study was an important first step and we are pleased with this result."
Alumis now plans to launch pivotal phase 3 trials for ESK-001 in the second half of this year, studies that will be fueled by the $259 million financing round the biotech closed just a few days prior to the data drop. The series C marked the biggest haul for a private biotech so far this year, according to Fierce Biotech’s Fundraising Tracker.
The new cash will also go toward Alumis’ other clinical trials, which include a phase 2b trial evaluating ESK-001 for patients with systemic lupus erythematosus and a proof-of-concept phase 2 study for the lead candidate in non-infectious uveitis. The biotech is also working to develop a once-daily tablet for ESK-001, according to the company release.
Editor's note: This article was updated at 5 p.m. ET on March 11 to include comment from Alumis' CEO.