Home biotech Phase 2 data for chronic inducible urticaria

Phase 2 data for chronic inducible urticaria

Image: Envato

Evommune, Inc. has presented additional positive data from its phase 2 trial of EVO756 in adults with chronic inducible urticaria (CIndU) in a late-breaker oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France.

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

“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. 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,” said Edward (Ted) Lain, a dermatologist and clinical investigator.

EVO756 is a potent and highly selective oral small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2). By targeting MRGPRX2, Evommune believes EVO756 has industry-leading potential with a differentiated approach to treating disease. EVO756 has been observed to deliver modulation on both mast cells and peripheral sensory neurons, representing a new potential therapeutic option to reduce inflammation and provide rapid relief of itch (pruritus).

The0 multicentre 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. Enrolment targeted a real-world cross-section of patients with both IgE high 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 data highlights include:

Robust clinical activity in both 300 mg QD and 50mg BID doses: Clinical responses observed in 93% of patients at just four weeks in either FricTest score or Pruritus-NRS; 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%

Rapid onset: Improvements in both Pruritus NRS and FricTest scores observed within one week (including three patients with complete responses)

Broad applicability: 50% of complete responders were IgE high (≥100 IU/mL), demonstrating clinical improvement was not limited to IgE low subjects

Well-tolerated: No serious adverse events or treatment discontinuations due to adverse events

“These encouraging data demonstrate that by targeting MRGPRX2, EVO756 modulates both mast cells and peripheral sensory neurons, representing a new potential therapeutic approach that can impact the underlying disease by both reducing inflammation and providing rapid relief of itch. Today’s presentation marks the first detailed clinical data publicly presented on this dual mechanism,” said J. Mark Jackson, VP, clinical development at Evommune.

“Despite different triggers, aberrant mast cell activation is common to CIndU, CSU and AD and early relief of the hallmark symptom of itch in CIndU has the potential to translate similarly in CSU and AD. We look forward to sharing top-line data from our 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.”

Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.

Exit mobile version