Evelo Biosciences Reports that EDP2939, its First Oral Extracellular Vesicle Product Candidate, Commenced Dosing in a Phase 2 Psoriasis Trial
– Completed first blinded, placebo-controlled cohort in human volunteers with no safety or tolerability concerns –
– Dosing in EDP2939 Phase 2 trial in patients with moderate psoriasis has been initiated –
– EDP2939 Phase 2 data in psoriasis anticipated in 2H 2023 –
CAMBRIDGE, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered anti-inflammatory medicines acting on the small intestinal axis, SINTAX, today announced that its first extracellular vesicle (EV) product candidate, EDP2939, has progressed to dosing in a Phase 2 psoriasis clinical trial after completing a safety and tolerability review from a first cohort of human volunteers. Safety and tolerability assessment of multiple ascending dose cohorts continues.
“This is a milestone for both EDP2939 and Evelo’s broader platform of orally-delivered EVs,” said Evelo’s Chief Medical Officer, Duncan McHale, M.B.B.S., Ph.D. “It is the first time that a potential bacterial EV medicine has been delivered orally to humans. Safety and tolerability are a central part of Evelo’s vision to develop medicines to treat all stages and all types of inflammatory diseases. We have now started dosing in the Phase 2 part of the trial in patients with moderate psoriasis.”
Mark Bodmer, Ph.D., President of R&D and Chief Scientific Officer of Evelo added, “EVs and EDP2939 show great promise as a new type of SINTAX medicine with potential for biologic-like efficacy based on three factors: (1) the high intrinsic potency of EVs in preclinical models; (2) the number and concentration of EVs that can be delivered in a single capsule; and (3) the delivery to the target site of the proximal small intestine. We look forward to reporting EDP2939 psoriasis efficacy results, expected in the second half of this year.”
About the EDP2939 Trial
EDP2939-101 is a multi-center randomized, placebo-controlled, Phase 1/2 trial evaluating the safety, tolerability and clinical efficacy of EDP2939. Part A (Phase 1) of the trial is designed to determine safety and tolerability in human volunteers at multiple ascending doses. The primary endpoints of Part A are safety endpoints: AEs, SAEs, vital signs, safety laboratory tests, and ECGs.
Part B (Phase 2) is designed to determine the efficacy of EDP2939 in patients with moderate plaque psoriasis at the proposed therapeutic dose. The primary endpoint is the proportion of patients who achieve an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (a PASI-50 response) after 16 weeks of daily oral administration of EDP2939 or placebo. Secondary endpoints include several physician- and patient-reported psoriasis outcomes, as well as further safety evaluation. The trial will comprise approximately 110 patients randomized 1:1 to receive a single capsule of either EDP2939 or a matching placebo.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered anti-inflammatory medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. The small intestine plays a central role in governing inflammation throughout the body. The Company’s product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles (EVs). Evelo initially is developing EDP1815 in psoriasis and atopic dermatitis and EDP2939 in psoriasis. Evelo’s vision is to create therapies that are effective, safe, well-tolerated, and affordable to improve the lives of the billions of people living with inflammatory diseases. If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease.
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