Arcutis Biotherapeutics to Terminate Phase 2a Vitiligo Study

Arcutis Biotherapeutics announced early termination of its phase 2a trial evaluating ARQ-252 as a potential treatment for vitiligo citing to inadequate local drug delivery to the skin.

Arcutis Biotherapeutics announced it had decided to terminate its recently initiated phase 2a clinical trial (NCT04811131) investigating ARQ-252 as a potential treatment for vitiligo.1

ARQ-252 is a topical small molecule Janus kinase 1 (JAK1) inhibitor. Arcutis believes that due to ARQ-252’s high selectivity for JAK1 over JAK2, the topical has the possibility to treat inflammatory diseases without causing hematopoietic adverse effects that are typically associated with inhibition of JAK2, according to the press release.

The decision for termination of the trial is based on analyses of ARQ-252’s formulation in the vitiligo study and a completed phase 2b study investigating the drug as a potential treatment for chronic hand eczema (NCT04378569).

In the chronic hand eczema study, ARQ-253 failed to meet its primary endpoint and none of the ARQ-252 treatment arms achieved statistical significance vs vehicle. Additionally, further analyses of that study indicated the lack efficacy was possibly linked to inadequate local drug delivery to the skin.

“While we are disappointed to terminate this vitiligo study, we believe topical JAK inhibition remains a promising strategy for the treatment of both chronic hand eczema and vitiligo, and that ARQ-252 has potential as a new treatment for both diseases. Published clinical data for other topical JAK inhibitors have shown encouraging results in both indications. Furthermore, the active pharmaceutical ingredient in ARQ-252 — SHR0302 — is a potent and highly selective JAK1 inhibitor that has demonstrated efficacy and safety as an investigational oral formulation in other inflammatory conditions such as rheumatoid arthritis and atopic dermatitis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis Biotherapeutics.

He added, “We have already made good progress in reformulating ARQ-252 to potentially deliver much more active drug to targets in the skin and hope to re-enter the clinic with this reformulated version in the not-too-distant future. We want to thank the patients and investigators in the vitiligo study for their participation.”

Arcutis notes the vitiligo study was not terminated due to any safety or tolerability issues and adds that ARQ-252 has been observed as safe and well-tolerated, with no unexpected safety signals identified.

The company plans on working on a new formulation with goal of greater drug delivery.

Reference:

1. Arcutis provides update on phase 2a clinical trial evaluating arq-252 cream as a potential treatment for vitiligo - arcutis biotherapeutics. Accessed July 6, 2021. https://investors.arcutis.com/news-releases/news-release-details/arcutis-provides-update-phase-2a-clinical-trial-evaluating-arq/