Item 8.01. Other events.

Evelo Biosciences, Inc. (the “Company”) recently updated its business information as follows:

Clinical Responses Observed in the Post-Treatment Period of the Phase 2 Clinical Trial of Oral EDP1815 in Psoriasis

At February 28, 2022the company announced data from the post-treatment follow-up period of its Phase 2 trial of EDP1815 in mild and moderate psoriasis, which included durable and more profound clinical responses.

The Phase 2 EDP1815-201 trial included Part A, when patients received either EDP1815 or a placebo for 16 weeks, and Part B, when patients were followed up to 24 weeks after stopping EDP1815 or a placebo. placebo. Eighty-three patients who received EDP1815 in Part A entered Part B. Thirty of these 83 patients achieved PASI-50 (50% reduction in Psoriasis Area and Severity Index score from baseline) or greater reduction at week 16 of Part A. Eighteen of 30 patients remained at PASI-50 or higher at the end of Part B. Ten of 30 patients had achieved PASI-75 or higher at the end of Part A and 5 remained at PASI-75 or higher at the end of Part B. These lasting results were achieved without any new psoriasis medications being used during this time. Nineteen of the 83 patients had achieved clear skin (PGA 0) or almost clear skin (PGA 1) at the end of Part A and of these, 9 remained at PGA 0/1 at the end of Part A. B.

Of the 30 patients who achieved a PASI-50 at the end of Part A and entered Part B, 10 had already achieved a PASI-75 response by week 16 in Part A. Of the remaining 20 patients, 9 achieved a PASI-75 or greater response during the post-treatment period. These data, combined with durability data, suggest that longer dosing may lead to further deepening of responses in some patients.

Tolerance and safety data for EDP1815 in the trial were comparable to placebo, with the additional finding of no relapse or rebound after discontinuation (which are often seen with other treatments for psoriasis).

About EDP1815-201

EDP1815-201 was a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-testing trial in adult patients with mild and moderate psoriasis. The study consisted of Part A (treatment phase) and Part B (extended follow-up, off-treatment phase).

In Part A of this trial, 249 patients were randomized in a 1:1:1 ratio to one of three parallel cohorts: 1 capsule, 4 capsules or 10 capsules. They were then randomized 2:1 active against placebo before starting dosing. Study drug was taken once daily for 16 weeks, and patients were followed for 4 weeks after treatment ended through week 20. In the trial, PASI scores were assessed at the both by mean changes from baseline and by responder rates. The primary endpoint was mean percent change in PASI between treatment and placebo. Secondary endpoints included the proportion of trial participants achieving a PASI-50 or greater response. The primary endpoint at 16 weeks yielded probabilities of EDP1815 being superior to placebo ranging from 80% to 90% in predefined analyzes and cohorts. 25% to 32% of patients in the three cohorts who were treated with EDP1815 achieved PASI-50 at week 16, compared to 12% on placebo.

All patients had the option of participating in Part B of the trial. The objective of Part B was to assess the durability of response to treatment and the incidence of rebound (eg, increase in PASI score to 125% of baseline or above, or occurrence of new pustular erythrodermic psoriasis within 3 months of stopping treatment) after discontinuation of dosing. Patients in Part B were assessed at follow-up visits at weeks 24 and 28. Only patients who achieved PASI-50 or greater at week 16 were also assessed at week 40. Patients were not not allowed to start other psoriasis treatments or trials during Part B.

Forward-looking statements

This current report contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this current report that do not relate to historical facts should be considered forward-looking statements, including , but not limited to, statements regarding the development of EDP1815 and the promise and potential impact of EDP1815.

These forward-looking statements are based on management’s current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or future achievements expressed or implied by the forward-looking statements. forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on the Company’s business, including the Company’s preclinical studies and clinical trials, and


business continuity of the Company; that the Company has suffered significant losses, is not currently profitable and may never become profitable; the Company’s need for additional financing; the Company’s limited operating history; the Company’s unproven approach to therapeutic intervention; the lengthy, costly and uncertain process of clinical drug development, including potential delays in regulatory approval; the Company’s reliance on third parties and collaborators to expand the Company’s microbial library, conduct clinical trials, manufacture product candidates and develop and commercialize product candidates, if approved; the Company’s lack of experience in manufacturing, selling, marketing and distributing the Company’s product candidates; the inability to successfully compete with other pharmaceutical companies; issues of protection of the Company’s proprietary technology and confidentiality of the Company’s trade secrets; potential lawsuits or claims for infringement of third-party intellectual property or disputes over ownership of the Company’s intellectual property; the Company’s patents being declared invalid or inapplicable; risks associated with international operations; the Company’s ability to retain key personnel and manage growth; the potential volatility of the Company’s common stock; that the management and the main shareholders of the Company have the ability to control or significantly influence the activities of the Company; costs and resources of operating as a public company; unfavorable or non-existent research or analyst reports; and a securities class action lawsuit against the Company.

These and other important factors discussed under “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended September 30, 2021and our other reports filed with the SECOND, could cause actual results to differ materially from those indicated by the forward-looking statements made in this current report. These forward-looking statements represent management’s estimates as of the date of this current report. Although the Company may elect to update these forward-looking statements at some time in the future, except as required by law, the Company disclaims any obligation to do so, even if subsequent events cause a change of opinion of the society. These forward-looking statements should not be taken to represent the views of the Company as of any date after the date of this current report.

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