The study will evaluate the MRGPRX2 antagonist in healthy adults and adults with CSU.
Evommune has announced today the initiation of its phase 1 trial of oral EVO756, a MRGPRX2 antagonist, for the treatment of chronic spontaneous urticaria (CSU) in adult patients.
The initiation of this study marks the first-in-human study of EVO756.
The phase 1 study is double-blinded, open label, placebo-controlled, and randomized in nature and will evaluate the safety, pharmacokinetics, and tolerability in this indication. It will feature multiple ascending doses of EVO756 in adults with CSU and otherwise healthy adults.
Researchers will assess efficacy based on outcomes of a skin challenge test, wherein the potential of EVO756 on mast cell degranulation will be analyzed. According to the press release, this method will mimic the impact of EVO756 versus a placebo against induced urticarias in the healthy control group of participants.
If approved, EVO756 has the potential to become a first-in-class oral treatment for CSU and several other mast cell-mediated diseases. Considering its function on peripheral sensory neurons, EVO756 may also be a candidate for pruritus relief in itch-related disorders such as atopic dermatitis.
"As a company committed to developing a pipeline of therapeutics to halt the progression of chronic inflammatory diseases, we are excited to dose the first volunteer in our Phase 1 trial of EVO756," said Eugene Bauer, MD, chief medical officer at Evommune, in the press release.
"By targeting mast cells via the selective modulation of MRGPRX2, we aim to deliver a novel therapeutic with the efficacy of a biologic and the potential for once-daily oral administration, without the safety challenges of alternative mast cell depleting options," Bauer said. "In CSU patients, blockade of the MRGPRX2 receptor and its subsequent downstream effect has the potential to treat the root cause of inflammation, offering greater relief than currently available treatments."
Evommune. Evommune announces initiation of a phase 1 trial of its MRGPRX2 antagonist for the treatment of chronic spontaneous urticaria. PR Newswire. January 18, 2024. Accessed January 18, 2024. https://www.prnewswire.com/news-releases/evommune-announces-initiation-of-a-phase-1-trial-of-its-mrgprx2-antagonist-for-the-treatment-of-chronic-spontaneous-urticaria-302037378.html#:~:text=PALO%20ALTO%2C%20Calif.%2C%20Jan,adults%20and%20adults%20with%20chronic