Evelo Biosciences Announces Dosing of First Patient in Phase 2 Trial

Evelo Biosciences, Inc. recently announced the first patient has been dosed in EDP1815-207, its Phase 2 randomized clinical trial of EDP1815 for the treatment of patients with mild, moderate, and severe atopic dermatitis.

“We are pleased that dosing has begun in the Phase 2 trial to evaluate the potential of this novel product candidate to benefit people worldwide who are living with atopic dermatitis,” said Jonathan Zung, PhD, Chief Development Officer of Evelo. “Our previously released Phase 1b data, together with the positive results we recently released from our Phase 2 trial in mild and moderate psoriasis, demonstrate that EDP1815 has the potential to be a safe, effective, well tolerated, oral, inflammation resolving therapy.”

“Patients and prescribers are in need of a therapy that is safe and well tolerated, as well as orally delivered, for the treatment of atopic dermatitis,” said Benjamin Ehst, MD, PhD, Board-certified Dermatologist, Investigator and Clinical Associate Professor with the Oregon Medical Research Center, and Chief Investigator of EDP1815-207. “The integrated safety, tolerability, and efficacy data seen in the Phase 2 trial of EDP1815 in psoriasis, along with its oral administration and potential to be affordably priced, could provide meaningful change to the treatment paradigm for patients living with atopic dermatitis.”

Topline results from the Phase 2 clinical trial are expected in 1H 2023.

EDP1815-207 is a 16-week, multi-center, double-blind, placebo-controlled Phase 2 trial for the treatment of mild, moderate, and severe atopic dermatitis. Approximately 300 patients will be randomized, across approximately 60 sites globally, into one of three cohorts – each cohort has ~100 patients randomized in a 3:1 ratio (75 to EDP1815 and 25 to placebo). Cohort 1 will be administered a dose of 1.6 x 10¹¹ total cells of EDP1815, or matching placebo administered as two capsules once daily. Cohorts 2 & 3 will be administered a dose of 6.4 x 10¹¹ total cells of EDP1815, or matching placebo administered as two capsules once daily or one capsule twice daily, respectively. The primary endpoint is percentage of patients achieving an EASI-50 at week 16. Key physician-reported secondary endpoints are IGA (Investigator Global Assessment) and BSA (Body Surface Area). Key patient-reported secondary endpoints are DLQI (Dermatology Life Quality Index), POEM (Patient-Oriented Eczema Measure), and Pruritus-NRS (Numerical Rating Scale).

EDP1815 is an investigational oral medicine being developed for the treatment of inflammatory diseases. It is a non-live pharmaceutical preparation of a strain of Prevotella histicola, selected for its potential to provide systemic pharmacological effects after oral administration with gut-restricted distribution. Being non-live, it has not been observed to colonize the gut or modify the microbiome. Preclinically, EDP1815 had anti-inflammatory effects in models that cover multiple pathways of inflammation, Th1, Th2, and Th17. Clinical results from multiple independent cohorts provide evidence supporting EDP1815’s potential to address Th1, Th2 and Th17-mediated inflammation.

Evelo Biosciences is a clinical stage biotechnology company developing orally delivered product candidates that are designed to act on the small intestinal axis, SINTAX, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases.

Evelo currently has three product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases. Evelo is advancing additional product candidates in other disease areas. For more information, visit www.evelobio.com.