Evelo Biosciences' Atopic Dermatitis Study Fails, Observes Unusually High Placebo Response Rates

  • Evelo Biosciences Inc EVLO said it observed an unusually high placebo response rate in the first three cohorts of the EDP1815 Phase 2 atopic dermatitis study, resulting in a missed primary endpoint.
  • The company said it is working through the data to understand the very high placebo rates observed in the trial, which occurred with greater prevalence in certain geographic regions. 
  • The trial's fourth cohort, designed to test the faster release formulation, is fully recruited, and data from this cohort is expected in Q2 2023.
  • The first three cohorts of the EDP1815-207 trial failed to meet the primary endpoint, the proportion of patients who achieved an outcome of at least a 50% improvement from baseline in Eczema Area and Severity Index score compared to placebo at week 16.
  • In all three cohorts, EDP1815 was well-tolerated.
  • EASI-50 responses or greater were achieved in 41%, 38%, and 32% of patients with mild to moderate disease at week 16 in cohorts 1, 2, and 3, respectively.
  • Patients on placebo had an overall EASI-50 response of 56%. Placebo responses varied significantly by geography.
  • The company's Board of Directors has asked Simba Gill to remain in his position as CEO, and the company has halted the search for his successor.
  • The company has taken actions to implement cost reduction initiatives, including a reduction in the workforce, expected to extend its cash runway into 3Q 2023.
  • Evelo is actively discussing partnership opportunities across EDP1815, EDP2939, and the EV platform.
  • Price Action: EVLO shares are down 21.19% at $0.8196 on the last check Wednesday.
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