Flagship-founded microbiome biotech shelves lead asset after another round of cohort data flops

Flagship Pioneering-founded Evelo is moving on from its lead asset after additional dose cohort data in patients with atopic dermatitis mirrored past failures, with more job cuts on the way.

Evelo’s decision to rip the Band-Aid off its pipeline comes after more data from lead asset EDP1815 missed the phase 2 trial’s primary endpoint, according to an announcement from the company Wednesday. The drug was assessed using the proportion of patients who had a 50% reduction in eczema severity compared to placebo. Evelo says 37.9% of treated patients had a 50% reduction by Week 16 following treatment compared to 44.7% who experienced the reduction in the placebo group. 

The results follow similarly disappointing data in three other cohorts released in February

But the latest data are evidently the final straw for Evelo, which has decided to scrap EDP1815 in the indication. Evelo has yet to decide whether to continue developing EDP1815 in psoriasis, a spokesperson confirmed to Fierce Biotech. The company says it will also cut staff to save costs. 

When Evelo first announced in February that the trial had come up short, 48 employees were shed, but CEO Simba Gill, Ph.D., stayed on. Pressure had been mounting after the company shelved phase 1 asset EDP1867 a year earlier after poor results in patients with—you guessed it—atopic dermatitis. 

A spokesperson for Evelo confirmed this will be a new round of layoffs, but the size of the reduction is not being publicly disclosed at this time. 

The company’s already low share price fell yet again Wednesday, down to 13 cents. Evelo received a delisting warning from the Nasdaq in March. 

Now the spotlight turns toward Evelo’s extracellular vesicle platform, which will be prioritized from here on out. Enrollment has been completed for the first treatment from the platform, EDP2939, in the phase 2 portion of a phase 1/2 trial in patients with psoriasis. Evelo expects top-line data from the phase 2 portion to be available by the fourth quarter of 2023. 

Evelo is the latest in a line of Flagship-launched companies that’s failed to tap into the therapeutic potential of the microbiome. Fellow Flagship company Kaleido Biosciences shut down in April 2022 after its pipeline failed to materialize following a warning from the FDA that the company was improperly running trials for one of its assets.