Excellent long-term data for TYK2 inhibitor ESK-001 in psoriasis

The investigational TYK2 inhibitor ESK-001 was well tolerated and displayed promising efficacy data in a phase 2 trial including patients with moderate-to-severe plaque psoriasis. A phase 3 study has been launched to further assess this agent in over 600 participants with this skin condition.

Previously, the STRIDE study showed that the TYK2 inhibitor ESK-001 was associated with high Psoriasis Area and Severity Index score (PASI)75 rates in patients with plaque psoriasis at week 12 [1]. At this timepoint, 64.1% of participants treated at the highest dose level (i.e. 40 mg twice daily) reached this endpoint, compared with 0.0% of the participants on placebo. Dr Andrew Blauvelt (Blauvelt Consulting LLC, MD, USA) presented the first results of the subsequent open-label extension study [2]. “Today, I will present efficacy data from the participants who received the highest dose in the induction study and continued on this dose level during the open-label extension study [n=82], and safety data from a broader population of participants [n=164],” Dr Blauvelt explained.

The drug was well tolerated throughout 52 weeks, with most side effects being mild or moderate in severity and self-limiting. “Acne was only reported in 3.7% of the participants, and there were just 2 cases of herpes zoster and 1 case of herpes simplex,” highlighted Dr Blauvelt. In terms of efficacy, PASI rates increased with longer-term use of ESK-001, with PASI75, PASI90, and PASI100 rates of 77.5%, 61.3%, and 38.8% at week 52, respectively.

“We observed that responses improved over time with high-dose ESK-001 without causing serious safety issues,” decided Dr Blauvelt. “The ONWARD study will test this agent in another 600+ patients with plaque psoriasis.”

1. 
   
   1. Papp KA. LB1, 2024 AAD Annual Meeting, 08–12 March, San Diego, USA.
   2. Blauvelt A, et al. ESK-001, a highly selective oral TYK2 inhibitor: 52-week phase 2 study results in moderate-to-severe plaque psoriasis. S028, Late Breaking Research Session 1, 2025 AAD Annual Meeting, 07–11 March, Orlando, FL, USA.

Copyright ©2025 Medicom Medical Publishers



Posted on 17 April 2025