Evelo Biosciences Completes Enrollment to Interim Target in Phase 2 Trial Evaluating EDP1815 for the Treatment of Psoriasis
Evelo Biosciences (Nasdaq: EVLO) has completed patient enrollment ahead of schedule for its Phase 2 trial of EDP1815, aimed at treating mild to moderate psoriasis. The interim data readout will cover initial safety and efficacy results for the first 113 patients. EDP1815 is an oral biologic designed to address inflammatory diseases. The trial evaluates three doses of EDP1815 over 16 weeks, focusing on reduced Psoriasis Area and Severity Index (PASI) scores as the primary endpoint.
- Early patient enrollment for the EDP1815 trial completed ahead of schedule.
- The interim results will provide initial safety and efficacy data, valuable for future developments.
- No immediate financial metrics or results have been disclosed, leaving uncertainty around market impact.
CAMBRIDGE, Mass., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines which act in the small intestine with systemic effects, today announced that it is recruiting ahead of schedule and has completed enrollment of the patients necessary for the interim data readout in the Phase 2 clinical trial evaluating EDP1815 for the treatment of mild to moderate psoriasis. The interim data readout will include initial safety and efficacy data for the first 113 patients enrolled in the trial. EDP1815 is an investigational oral biologic in development for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19.
“We are encouraged by the physician and patient interest in our Phase 2 trial, which has enabled us to complete enrollment to the interim target ahead of schedule despite the ongoing COVID-19 pandemic,” said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. “Based on recent interactions with key opinion leaders, we see a growing understanding of the potential of SINTAX™ medicines to resolve systemic inflammation without immunosuppression, anticipating that EDP1815 may offer an improved profile over existing products and others in development as an orally-administered, safe, and effective medicine to address the needs of the millions of people with psoriasis.”
EDP1815-201 is a double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in 225 patients with mild to moderate psoriasis over a 16-week treatment period. The primary endpoint is mean reduction in Psoriasis Area and Severity Index (PASI) score at 16 weeks. Key secondary endpoints include other clinical measures of disease such as Physician’s Global Assessment (PGA), Body Surface Area (BSA), PGA x BSA, Psoriasis Symptom Inventory (PSI), Dermatology Life Quality Index (DLQI), and Lesion Severity Score (LSS).
About EDP1815 in Psoriasis
EDP1815 is an investigational oral biologic being developed for the treatment of inflammatory diseases. EDP1815 is a strain of Prevotella histicola, selected for its specific pharmacology. In the second and third quarter of 2019, Evelo reported positive Phase 1b interim clinical data in two cohorts of patients with mild to moderate psoriasis. EDP1815 was well tolerated at both doses, with no overall difference reported from placebo. There was a reduction in mean LSS and PASI score after 28 days of dosing in both cohorts who received EDP1815. In the high dose cohort alone, there was a continued reduction in both mean LSS (of
About Psoriasis
Psoriasis is a common chronic immune-mediated inflammatory skin disease, affecting up to
Patients with mild to moderate psoriasis are underserved by current treatments, including topical therapies, which do not control systemic inflammation, have low rates of compliance, or in the case of potent topical steroids, are not recommended for long-term use. The majority of novel therapies, including injectable high-cost biologics, are only approved for patients with moderate to severe disease. Even in this patient population, the majority of eligible patients do not receive biologics, instead opting for topical or oral systemic therapies, which are associated with tolerability issues and/or with monitoring requirements tied to safety concerns.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing oral biologics that act on SINTAX™, the small intestinal axis, 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 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 and cancer.
Evelo currently has five product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.
