Evelo Biosciences' Atopic Dermatitis Study Cohort Misses Primary Goal Again, Shuts Study, Lays Off More Staff

Evelo Biosciences Inc EVLO said its fourth cohort of the EDP1815 Phase 2 trial in atopic dermatitis, consistent with the first three cohorts, failed to meet the primary endpoint of the proportion of patients who achieve an EASI-50 response at week 16.

EASI-50 responses or greater were achieved at week 16 in 37.9% of patients dosed with EDP1815 versus 44.7% on placebo in the fourth cohort.

Following the results, the company decided to cease further development of EDP1815 in atopic dermatitis.

"The faster release formulation of EDP1815, dosed in cohort 4, was generally well tolerated. The potential impact on the efficacy of the faster release formulation cannot be determined from this study," said CEO Simba Gill.

Instead, Evelo will focus its resources on the next-generation extracellular vesicle (EV) platform and EDP2939, its first EV candidate, currently in a Phase 1/2 study in psoriasis.

"We are prioritizing investment in the EV platform and EDP2939 clinical development and are reducing our workforce to save costs," Gill added.

The company said enrollment is complete in the Phase 2 portion of the Phase 1/2 study of EDP2939-101, with topline data expected in Q4 2023.

The safety review committee reviewed data for the completed cohorts 1 and 2 of Phase 1 healthy volunteer portion of the study and reported no notable safety or tolerability concerns.

In February, Evelo Biosciences 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.

Then also the company implemented cost reduction initiatives, including a reduction in the workforce, to extend its cash runway into 3Q 2023.

Price Action: EVLO shares are down 27% at $0.11 on the last check Wednesday.