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EADV 2025 News: Evommune, Inc.’s EVO756 Shows Robust and Rapid Improvement in CindU Patients

Evommune, Inc.’s EVO756 continues to show promise in adults with chronic inducible urticaria (CIndU), according to new Phase 2 data presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France.

EVO756 is a potent and highly selective oral small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2) which has been observed to deliver modulation on both mast cells and peripheral sensory neurons.

This multicenter, Phase 2 trial was conducted in 30 adults with symptomatic dermographism (common CIndU subtype) with patients serving as their own control. Patients needed to qualify at both screening and baseline, without demonstrating spontaneous resolution during the 30-day screening window. Enrollment targeted a real-world cross-section of patients with both IgE high (≥100 IU/ml) and low at baseline.

EVO756 was administered orally for four weeks at either 300mg once daily (QD) or 50mg twice daily (BID). Efficacy was measured by FricTest provocation scores and Pruritus Numeric Rating Scale (NRS) and safety assessments were performed at each visit.

Key takeaways include:

  • Robust clinical activity in both 300mg once daily (QD) and 50mg twice daily (BID) doses
  • Clinical responses observed in 93% of patients at just four weeks in either FricTest score or Pruritus-NRS
  • Fully 70% of patients demonstrated an improvement in FricTest score at just four weeks, with 30% of patients achieving a complete response;
  • Reduced Pruritus-NRS observed at week 4 in 78% of patients, with a ≥4-point reduction observed in 41% of patients
  • Improvements in both Pruritus NRS and FricTest scores observed within one week (including three patients with complete responses)
  • Fifty percent of complete responders were IgE high (≥100 IU/mL), demonstrating clinical improvement was not limited to IgE low subjects
  • No serious adverse events or treatment discontinuations due to adverse events

“The full Phase 2 data presented today highlight EVO756’s differentiated mast cell dual mechanism, with responses observed as early as one week and after four weeks of oral treatment,” says Edward (Ted) Lain, MD, M.B.A., a Dermatologist in Austin, TX and clinical investigator. “Additionally, EVO756 was generally well-tolerated, and when taken together with the previously announced top-line data, these data also demonstrate the potential for more improvement with continued dosing beyond four weeks, suggesting that EVO756, if approved, could be a compelling alternative to biologics and other approaches.”

The Company plans to share top-line data from ongoing Phase 2b studies of EVO756, with CSU data expected in the first half of 2026 and AD data expected in the second half of 2026.

 

*Evommune previously announced top-line data from this trial in May 2025.

 

PHOTO CREDIT: DermNet