Evelo Biosciences Inc. (NASDAQ: EVLO) has reported promising data from the second phase trial studying EDP1815 compared to placebo treatment for moderate and mild psoriasis.
EDP1815 could potentially treat psoriasis
The study found a statistically significant Psoriasis Area and Severity Index (PASI) score reduction, as measured through the patients’ percentage who improved by at least 50% from baseline after 16 weeks. EDP1815 is an experimental oral biologic in development to treat a variety of inflammatory illnesses, including atopic dermatitis, psoriasis, and COVID-19.
CEO Simba Gill said, “These clinical results represent a significant advancement for those who live with inflammatory disease. This is the first Phase 2 study to demonstrate that we can harness the small intestinal axis to make a clinical impact on patients with an oral product candidate with safety and tolerability data comparable to placebo. Based on these data, we intend to advance EDP1815 towards registration studies in psoriasis. We look forward to discussing our proposed next steps with health and regulatory authorities.”
Study endpoint was PASI percentage change
The company assessed both mean changes of PASI scores from responder rates and baseline. The study’s primary endpoint was the average PASI percentage change between treatment arm and placebo, prespecified in Bayesian analysis. The Bayesian approach offers an estimate showing that is the probability of EDP1815 being superior between 80-90% across prespecified cohorts and analyses relative to placebo.
Study investigator Benjamin Ehst said, “I am very encouraged to see this Phase 2 data of EDP1815 in psoriasis. It advances our scientific understanding of how to treat systemic inflammatory diseases and offers the prospect of a truly novel modality of treatment for patients with psoriasis. A drug with the combination of efficacy and safety results as observed here will likely be well received by dermatologists and their patients with mild and moderate disease, who are often faced with limited treatment options.”