EDP2939 / Evelo Biosci - LARVOL DELTA

Evelo Biosciences Announces Top-Line Results From its Phase 2 Clinical Study with EDP2939 in Moderate Psoriasis (GlobeNewswire) - P2 | N=146 | "Evelo Biosciences, Inc...today announced top-line results from its Phase 2 clinical study with EDP2939 in moderate psoriasis. The study’s primary endpoint, the difference in the proportion of patients who achieved an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (a PASI-50 response) between EDP2939 and placebo after 16 weeks of daily treatment, was not achieved....Although there was no statistically significant difference between the proportion of patients who achieved a PASI-50 response on EDP2939 compared to placebo, it was notable that such numeric proportion went from being inferior to placebo at week 16 (19.6% on EDP2939 vs 25% on placebo) to being superior at the week 20 follow-up visit (33.9% on EDP2939 vs 26.9% on placebo). Ongoing analysis of the secondary endpoints continues....Based on these results, Evelo has initiated a process to explore strategic alternatives."

P2 data • Immunology • Psoriasis

Evelo Biosciences Closes $25.5 Million Private Placement (GlobeNewswire) - "Evelo Biosciences, Inc...announces that it closed the previously announced private placement, resulting in gross proceeds of approximately $25.5 million from the sale of 11,025,334 shares of its common stock at a purchase price of $2.31 per share. The offering was led by Evelo’s founder, Flagship Pioneering, with participation from other existing and new investors. Net proceeds from the private placement will be used to fund completion of the Company’s ongoing Phase 2a trial of EDP2939 in moderate psoriasis, to pay down approximately $5 million of debt and for general corporate purposes."

Financing • Immunology • Inflammation • Psoriasis

Evelo Biosciences Announces $25.5 Million Private Placement (GlobeNewswire) - "Evelo Biosciences, Inc...today announced that it has entered into a securities purchase agreement with investors in a private placement to sell 11,025,334 shares of its common stock (the 'Shares') at a purchase price of $2.31 per share, which would result in gross proceeds of approximately $25.5 million....Evelo intends to use the net proceeds from the private placement to fund the readout of its Phase 2a trial of EDP2939 in moderate psoriasis, to pay down approximately $5.0 million of its existing debt and for general corporate purposes."

Financing • Immunology • Psoriasis

Evaluation of the Immunopharmacology of EDP1815 and EDP2939 (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Evelo Biosciences, Inc. | Recruiting ➔ Completed | N=72 ➔ 38 | Trial completion date: Apr 2023 ➔ Oct 2022 | Trial primary completion date: Apr 2023 ➔ Oct 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dermatitis • Inflammation

Evelo Biosciences’ Atopic Dermatitis Study Cohort Misses Primary Goal Again, Shuts Study, Lays Off More Staff (Yahoo Finance) - P2 | N=421 | NCT05121480 | Sponsor: Evelo Biosciences, Inc. | "Evelo Biosciences Inc...said its fourth cohort of the EDP1815 Phase 2 trial in atopic dermatitis, consistent with the first three cohorts, failed to meet the primary endpoint of the proportion of patients who achieve an EASI-50 response at week 16. EASI-50 responses or greater were achieved at week 16 in 37.9% of patients dosed with EDP1815 versus 44.7% on placebo in the fourth cohort. Following the results, the company decided to cease further development of EDP1815 in atopic dermatitis....Instead, Evelo will focus its resources on the next-generation extracellular vesicle (EV) platform and EDP2939, its first EV candidate, currently in a Phase 1/2 study in psoriasis....The company said enrollment is complete in the Phase 2 portion of the Phase 1/2 study of EDP2939-101, with topline data expected in Q4 2023."

Discontinued • P1/2 data • P2 data • Atopic Dermatitis • Dermatology • Immunology

Evelo Biosciences Announces Fourth Quarter and Full Year 2022 Financial Results and Business Highlights (GlobeNewswire) - P2 | N=405 | NCT05121480 | P1 | N=72 | NCT05682222 | Sponsor: Evelo Biosciences, Inc. | "EDP1815 – Atopic Dermatitis; Data from a fourth patient cohort of the Phase 2 study in atopic dermatitis evaluating the faster release capsule is anticipated in 2Q 2023. Cohorts one, two and three did not meet the primary endpoint of EASI-50 improvement as compared to placebo, due to an unusually high placebo response. No conclusions regarding the cause of the high placebo response have been identified....EDP2939 – Psoriasis; A safety and tolerability review was conducted in a first cohort of healthy volunteers in the Phase 1 portion of the trial, with no safety or tolerability concerns identified and resulting in approval to start the Phase 2 part of the trial. In February 2023, Evelo began dosing psoriasis patients in the Phase 2 portion of the trial, with data expected 2H 2023."

P1 data • P2 data • Trial status • Atopic Dermatitis • Dermatology • Immunology • Psoriasis

Evaluation of the Immunopharmacology of EDP1815 and EDP2939 (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Evelo Biosciences, Inc.

New P1 trial • Dermatitis • Immunology • Inflammation

A study to investigate EDP2939 in healthy volunteers and participants with moderate psoriasis. (clinicaltrialsregister.eu) - P2 | N=146 | Ongoing | Sponsor: Evelo Biosciences, Inc.

New P2 trial • Dermatology • Immunology • Psoriasis • Rheumatology

Evelo Biosciences Reports Second Quarter 2021 Financial Results and Business Highlights (GlobeNewswire) - "Evelo announced that it has finalized the design of the EDP1815 Phase 2 clinical trial in atopic dermatitis. The trial will be a 12-week, double-blind, placebo-controlled, multiple cohort trial in patients with mild, moderate, and severe atopic dermatitis....All trial participants who complete the 12-week trial will be eligible to enroll into an open-label extension trial where they will receive EDP1815....Upcoming Key Milestones....EDP1815 – Atopic Dermatitis: Data from Phase 2 trial anticipated in 3Q 2022....EDP2939 – Inflammation: Initiation of clinical development in 2022."

Clinical protocol • New trial • P2 data • Atopic Dermatitis • Dermatology • Immunology

[VIRTUAL] Orally-delivered microbial extracellular vesicle induces anti-inflammatory activity in mice (IMMUNOLOGY 2021) - "We now extend these observations to EDP2939, a bacterial extracellular vesicle (EV), that has potent anti-inflammatory activity in preclinical models...EVs are particularly effective at engaging host cells in the gut to modulate distal inflammation. These data point to oral EVs as a new class of immunotherapeutic drugs."

Preclinical • Immunology • Inflammation • Systemic Inflammatory Response Syndrome

Evelo Biosciences Announces Pricing of Public Offering of Common Stock (GlobeNewswire) - "Evelo Biosciences, Inc....announced the pricing of an underwritten public offering of 4,500,000 shares of its common stock, at a public offering price of $15.00 per share...Evelo intends to use the net proceeds from the offering, in addition to its existing cash resources, for the following purposes: (i) continue the development of EDP1815 in a Phase 2 trial in psoriasis and initiate a Phase 2 trial of EDP1815 in atopic dermatitis; (ii) prepare to advance EDP1815 in multiple Phase 3 trials in psoriasis and atopic dermatitis...(iii) continue the Phase 2 and Phase 2/3 clinical trials of EDP1815 for the treatment of hyperinflammation caused by SARs-CoV-2; (iv) advance EDP1867 in a Phase 1b trial in atopic dermatitis; (v) progress its first bacterial extracellular vesicle product candidates into the clinic, including EDP2939 for inflammation and EDP1908 for oncology."

Financing • Atopic Dermatitis • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Psoriasis