Key Takeaways
- Evommune’s EVO756 trial failed to meet its primary endpoint in chronic spontaneous urticaria (CSU), ending its competitive prospects against Novartis.
- Despite the setback, EVO756 remains in testing for atopic dermatitis and migraine prevention.
- Analysts forecast a potential decline in Evommune’s stock value due to the trial failure and suggest low expectations for ongoing studies.
Trial Results and Implications
Evommune’s phase 2b trial of EVO756, an oral MRGPRX2 antagonist, has unfortunately missed its primary endpoint. The trial aimed to evaluate EVO756 against a placebo in adults suffering from moderate-to-severe chronic spontaneous urticaria (CSU), a condition characterized by persistent hives. A total of 160 participants, who had not responded to antihistamine treatments, were enrolled in the study, receiving one of three doses of EVO756 or a placebo. However, none of the treatment doses demonstrated a statistically significant improvement in the Urticaria Activity Score (UAS7) over seven days at the 12-week mark.
This outcome serves as a setback for Evommune and potentially benefits Novartis, which recently gained FDA approval for its BTK inhibitor, Rhapsido, for CSU. With the current trial results, Novartis faces reduced competition in the CSU market, having established a successful U.S. launch for Rhapsido in April 2025.
Future Trials and Market Response
Although the CSU trial did not support the further development of EVO756 for this condition, Evommune plans to continue its research. The biotech is moving forward with a phase 2b study for atopic dermatitis, expecting to release data in the third quarter. Additionally, they aim to begin patient dosing soon for a migraine prevention trial.
The recent failed CSU trial documented that all three doses of EVO756 were safe and well-tolerated, providing some positive insight for ongoing research. However, analysts from William Blair expressed concerns following the trial results. They noted that the failure could diminish investor confidence regarding atopic dermatitis or other itch-related conditions. In a June 29 note, analysts anticipated that expectations for the atopic dermatitis trial are now significantly low.
Dr. Gil Yosipovitch, a dermatology expert, emphasized the challenges related to the complex inflammation pathways involved in atopic dermatitis, making it difficult to treat this condition solely through MRGPRX2 antagonism.
Market Outlook
Analysts had previously assessed a strong chance of success for EVO756 in the CSU indication but noted difficulties faced by Incyte, which acquired the MRGPRX2 inhibitor EP262 in 2024. Incyte paused its EP262 trial due to preclinical toxicity concerns. Recent clinical data for EP262 also revealed limited efficacy compared to placebo in diminishing UAS7 scores.
While market analysts do not anticipate a direct correlation between outcomes in CSU and migraine studies, they warned that Evommune will need to present positive clinical data in the migraine space to restore investor confidence. Following the disappointing trial news, Evommune’s stock dropped 35% in premarket trading, falling from a closing price of $25.20 to $16.45. Analysts projected that continued failures, particularly in CSU, could result in a further share price decline to $15, driven primarily by the standing value of their phase 1 IL-18 program, EVO301.
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