Evelo Biosciences Completes Enrollment in Phase 1b Clinical Trial Cohort Evaluating EDP1815 in Atopic Dermatitis
“Topical therapies are the mainstay of treatment for mild and moderate atopic dermatitis but patient satisfaction and compliance is low, as many find existing regimens too inconvenient or unsatisfactory to support long-term use,” said
“We are pleased to announce that we have completed enrollment in our Phase 1b cohort evaluating EDP1815 in atopic dermatitis ahead of schedule, and are grateful to the patients who are participating in the trial, especially in the midst of the ongoing COVID-19 pandemic,” said
EDP1815-101 is a double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety and tolerability of EDP1815 in healthy volunteers and patients with psoriasis or atopic dermatitis. The atopic dermatitis cohort enrolled 24 patients with mild to moderate atopic dermatitis, randomized 2:1 to receive oral administration of 2.76g of the enteric capsule formulation of EDP1815 or placebo once daily, for 56 days. The primary endpoint is safety and tolerability. Secondary endpoints include key validated markers of atopic dermatitis, including the Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Dermatology Life Quality Index (DLQI), and Pruritis Numerical Rating Scale (Pruritis NRS).
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 two separate cohorts of a Phase 1b clinical trial in psoriasis, EDP1815 was well tolerated with no overall difference reported from placebo. Clinical activity observed included a reduction in mean Psoriasis Area and Severity Index (PASI) scores vs placebo, as well as a reduction in Lesion Severity Score (LSS). Two weeks following the completion of the dosing period, at day 42, the high dose cohort showed continued reductions from baseline in both mean PASI and LSS, which may be indicative of a sustained clinical effect and dose response. EPD1815 was also observed to limit the systemic production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1, which are well-established mediators of potentially harmful effects in patients with inflammatory diseases.
About Atopic Dermatitis
Atopic dermatitis, also known as eczema, is a common chronic inflammatory skin disease that affects both children and adults, with a prevalence of up to 10% in adults worldwide. It typically presents as a red, intensely itchy rash that may cause lifelong symptoms. Due to the chronic nature and frequency of relapses, atopic dermatitis is associated with a substantial physical and psychosocial burden on patients and their families. It can also occur alongside other atopic diseases including food allergy, asthma, and allergic rhinitis, as these conditions are all associated with an imbalance towards a Th2 inflammatory response – an immune pathway on which EDP1815 has been shown to have potent pre-clinical activity.
Patients with atopic dermatitis are often treated with topical medications, which are inconvenient and burdensome in application, leading to poor adherence and reduced efficacy in a real-world setting. Beyond topicals, patients have limited treatment options, especially patients with mild to moderate disease who may not have access to high-cost, injectable antibody therapies or may be uncomfortable with the toxicity concerns and monitoring requirements of systemic immunosuppressants. There is a large need across the spectrum of disease severity, and especially for these midline, pre-biologic patients, for a safe and well-tolerated oral medicine that resolves the systemic inflammation that drives atopic dermatitis.
Evelo currently has four product candidates in development: EDP1815, EDP1867 and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements concerning the timing and results of any clinical trials or readouts for EDP1815, our development plans, and the promise and potential impact of any of our therapies.
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
Source: Evelo Biosciences, Inc.