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Evelo Biosciences Completes Enrollment to Interim Target in Phase 2 Trial Evaluating EDP1815 for the Treatment of PsoriasisCAMBRIDGE, 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 About Psoriasis 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 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. For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn. Forward Looking Statements These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our management and principal stockholders have the ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Contact |