Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today provided an update on recent positive regulatory interactions on the EDP1815 Phase 2 trial design, resulting in a reduction in the overall development plan timeline to registration.
“The immunological effects of the small intestinal axis (“Sintax”), the connections between the small intestine and the body’s immune system, are the foundation for Evelo’s product candidates. We are harnessing the newly discovered biology of Sintax to develop a new class of oral medicines that modulate clinically validated cytokines to treat all stages of disease. In 2019, we reported positive clinical data with EDP1815 in individuals with psoriasis, which was the first clinical evidence of the promise that Sintax holds as a new drug target. Our strategy is to develop a new standard of care for millions of patients with chronic immunological diseases and cancer,” said Simba Gill, Ph.D., chief executive officer of Evelo.
“EDP1815 has the potential to address the unmet needs of millions of individuals with psoriasis who need an effective, safe, convenient, and affordable treatment option. Based on discussions with global regulatory agencies, including the FDA, we have finalized the design of our EDP1815 Phase 2 trial, resulting in a reduction in the overall development plan timeline to registration. The trial design will enable us to rapidly and efficiently highlight EDP1815’s potential benefits to individuals with psoriasis with a commercially attractive formulation and dose in advance of a potential Phase 3 program,” continued Dr. Gill. “In addition, we continue to explore the breadth of our platform, with further clinical readouts for our existing portfolio across cancer and inflammatory diseases expected this year. We also plan to initiate a Phase 1b trial in asthma for EDP1867, a new clinical candidate for inflammatory diseases. We will pursue these clinical programs alongside our broad research efforts to uncover the full potential of Sintax biology.”
EDP1815 – Phase 2 study in mild to moderate psoriasis
In the second and third quarter of 2019, Evelo reported positive Phase 1b interim clinical data in two cohorts of individuals with mild to moderate psoriasis. EDP1815 was well tolerated at both doses, with no overall difference reported from placebo. There was a reduction in mean Lesion Severity Score and PASI score after 28 days of dosing in both cohorts who received EDP1815. In the high dose cohort alone, there was a continued reduction in both mean Lesion Severity Score (of 24% vs. placebo of 7%) and PASI score (of 21% vs. placebo of 3%) at 42 days – 14 days following the last dose of the drug1. This may indicate a sustained clinical effect and dose response.
Evelo has agreed upon the design of the EDP1815 Phase 2 clinical trial with global regulatory agencies. The dose ranging study will evaluate three doses of a new, improved formulation of EDP1815 versus placebo in approximately 180 individuals. The primary endpoint will be the mean reduction in PASI score at 16 weeks. Evelo expects to initiate the trial in the second quarter of 2020 and to announce interim data by the end of 2020.
Subject to the Phase 2 clinical data, this study design may enable Evelo to advance directly into Phase 3 registrational studies in 2021. Furthermore, the recent regulatory interactions indicate that Evelo may be able to conduct a smaller overall Phase 3 program than expected, thereby reducing the development timeline to registration.
Additional Anticipated 2020 Milestones
EDP1815 – Phase 1b new formulation in mild to moderate psoriasis
- Initial data from an additional cohort in the EDP1815 Phase 1b trial to evaluate a new formulation in up to 24 individuals with mild to moderate psoriasis in the second quarter of 2020.
EDP1815 – Phase 1b new formulation in mild to moderate atopic dermatitis
- Initial data from the Phase 1b clinical trial evaluating a new formulation of EDP1815 in a cohort of 24 individuals with mild to moderate atopic dermatitis in the second quarter of 2020.
EDP1066 – Phase 1b new formulation in mild to moderate atopic dermatitis
- Initial data from the Phase 1b clinical trial evaluating a new formulation of EDP1066 in a cohort of individuals with mild to moderate atopic dermatitis in the first quarter of 2020.
EDP1867 – Phase 1b clinical trial in asthma
- Initiation of a Phase 1b clinical trial in individuals with asthma evaluating EDP1867, a new clinical candidate for inflammatory diseases, in the second half of 2020.
EDP1503 – Phase 1/2 in oncology
- Further data from the ongoing Phase 1/2 clinical trial evaluating EDP1503 in combination with Merck’s anti-PD-1, KEYTRUDA® (pembrolizumab), in individuals with microsatellite colorectal cancer, triple-negative breast cancer or other tumor types who have relapsed on prior PD-1/L1 inhibitor treatment, in the first half of 2020.