Benzinga | Apr 20, 2021 04:07PM EDT

Evelo Biosciences Presents Further Positive Data from Phase 1b Clinical Trial of EDP1815 in Atopic Dermatitis

--Evelo presents late-breaking abstract at the International Society of Atopic Dermatitis Annual Meeting--

--Meaningful improvements over placebo on clinical scores, including new data released on key IGA endpoints--

--Initiation of Phase 2 trial of EDP1815 in atopic dermatitis expected in 3Q 2021--

CAMBRIDGE, Mass., April 20, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today presented full clinical data from the Phase 1b clinical trial cohort evaluating EDP1815 for the treatment of mild and moderate atopic dermatitis in a poster presentation at the International Society of Atopic Dermatitis (ISAD) Hybrid Meeting 2021. The Company previously reported positive data for all 24 patients in the cohort, which is re-iterated in the presentation, together with new data on the Investigator Global Assessment (IGA) score.

The primary endpoint of the Phase 1b trial was safety and tolerability. As previously disclosed, EDP1815 was well tolerated, with no treatment-related adverse events of moderate or severe intensity and no serious adverse events. The full results reinforce the data released on January 20, 2021, demonstrating that treatment with EDP1815 resulted in clinically meaningful improvements in both patient- and physician-reported outcomes. At the day 70 follow-up visit, 31% more EDP1815-treated patients achieved an IGA score of 0 or 1 greater than placebo. At this same time point, 19% more EDP1815-treated patients reached an IGA score of 0 or 1 with a two-point improvement from baseline greater than placebo. This, in addition to the treatment differences seen within the Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and IGA times Body Surface Area (IGA*BSA) clinical endpoints as shown in the image below, suggests the potential of EDP1815 to be an effective, safe, well-tolerated, oral treatment for patients with mild and moderate atopic dermatitis.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/ba936911-286c-47fb-956e-411a4bcd10b4

https://www.globenewswire.com/NewsRoom/AttachmentNg/496f2e9d-4400-4f8a-8c95-591de9233f31

"We are pleased to present this complete dataset from our Phase 1b cohort at the ISAD conference, as it demonstrates the strong potential of EDP1815 as a therapy for patients with atopic dermatitis -- many of whom are underserved by a lack of effective, convenient, safe treatment options," said Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke's Hospital and Immunology Clinical Lead of Evelo. "We are further encouraged by the IGA data, which showed that EDP1815 has the potential to provide clinical benefit to patients. We look forward to initiating our Phase 2 atopic dermatitis trial in the third quarter of this year in patients with mild, moderate and severe atopic dermatitis."