Evelo Biosciences Unveils Exciting Clinical Updates!

Evelo Biosciences, Inc. (Nasdaq:EVLO) is taking major strides in the biotechnology industry with its unique platform of orally administered inflammation-resolving medicines. This pioneering platform, called SINTAX, is now making its way through clinical trials, and the company has just released updates on its progress. With this cutting-edge technology, Evelo Biosciences is set to revolutionize the way we treat inflammation.

Evelo’s CEO, Simba Gill, Ph.D., has announced that the primary endpoint of the fourth cohort of the study of EDP1815 in atopic dermatitis has not been met, thereby ceasing any further development of the product.

Despite the disappointment, the faster release formulation of EDP1815 was well-tolerated, and the impact on efficacy of the faster release formulation cannot be determined from this study. The company will now focus its resources on the next generation extracellular vesicle (EV) platform and on EDP2939, their first EV candidate, which is currently in a Phase 1/2 study in psoriasis.

Dr. Gill recently reported on the exciting potential of EDP2939, a new oral treatment for psoriasis and other Th1/Th17 driven inflammatory diseases, such as psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis and inflammatory bowel disease. Preclinical studies have demonstrated substantially more potent activity than EDP1815, and the Phase 2 clinical data in psoriasis with EDP1815 has been positive.

With the Phase 2 study of EDP2939 in moderate psoriasis now fully enrolled, we anticipate topline results to be released early in the fourth quarter of this year, and we believe that EDP2939 may have greater potential activity than EDP1815 in psoriasis, with similar tolerability.

I want to express my sincerest appreciation to the patients and clinicians who have dedicated their time and energy to our clinical development program, as well as our hardworking team for advancing our progress. As we prioritize investment in our EV platform and EDP2939 clinical development, we unfortunately have to reduce our workforce in order to save costs.

Clinical Updates

EDP1815 Phase 2 in Atopic Dermatitis – Topline Data

The fourth cohort of the EDP1815-207 trial sadly failed to meet its primary endpoint of achieving an EASI-50 response – a 50% improvement from baseline in Eczema Area and Severity Index (EASI) score – compared to placebo at week 16. Despite this setback, researchers remain determined to find a successful treatment for eczema.

At week 16, 37.9% of patients who took EDP1815 achieved an EASI-50 response or greater – noticeably higher than the 44.7% response rate among those taking the placebo in the fourth cohort.

The EDP1815 faster release capsule proved to be well-tolerated during trials, with participants experiencing no significant adverse reactions. Its speedy delivery system makes it a great option for those looking for fast-acting relief.

EDP2939 Phase 1/2 in Psoriasis

We are thrilled to announce that enrollment is now finished for the Phase 2 portion of EDP2939-101 – the landmark study of extracellular vesicles in moderate psoriasis. This project represents a major breakthrough in the understanding of this condition and is sure to provide invaluable insight into its treatment.

Phase 2 of the study is expected to provide results in the fourth quarter of 2023, giving us a glimpse into the data that could revolutionize our understanding of the subject.

The safety review committee conducted an extensive evaluation of the data collected from cohorts 1 and 2 of the Phase 1 trial involving healthy volunteers. Thankfully, no serious safety or tolerability issues were observed.

About the EDP1815-207 Trial

EDP1815-207 is a groundbreaking Phase 2 trial designed to uncover the potential of the novel drug EDP1815 in the treatment of atopic dermatitis. The randomized, double-blind, placebo-controlled trial enrolled patients with mild, moderate, and severe atopic dermatitis and investigated the efficacy and safety of EDP1815 when dosed for 16 weeks. Through four distinct cohorts, the study seeks to uncover the potential of EDP1815 in providing relief from the symptoms of atopic dermatitis.

The trial is designed to evaluate the efficacy of EDP1815 as a treatment for eczema. Patients are randomized into four cohorts, with Cohorts 1-3 including approximately 100 patients each and testing different concentrations, dosing regimens and manufacturing processes of EDP1815. Cohort 4, testing the faster release capsule, includes approximately 105 patients.

The primary endpoint of the trial is the proportion of patients who achieve an EASI-50 response of 50% improvement from baseline in their Eczema Area and Severity Index (EASI) score at week 16.

Secondary endpoints include physician-reported outcomes such as Investigator’s Global Assessment (IGA), body surface area (BSA) and patient-reported outcomes such as Dermatology Life Quality Index (DLQI), daily itch using the Pruritus-Numerical Rating Scale (Pruritus-NRS) and Patient-Oriented Eczema Measure (POEM). With the results of the trial, we hope to bring relief to those living with eczema.

About the EDP2939-101 Trial

EDP2939-101 is a groundbreaking multi-center randomized, placebo-controlled trial designed to evaluate the safety, tolerability and clinical efficacy of EDP2939. In Part A (Phase 1), human volunteers will be tested on multiple ascending doses to determine the safety endpoints, including AEs, SAEs, vital signs, safety laboratory tests, and ECGs. By participating in this trial, volunteers will contribute to the cutting-edge advancements in the medical field.

Phase 2 of the trial for EDP2939 evaluates its efficacy in treating moderate plaque psoriasis in patients. The primary endpoint is the proportion of patients who achieve a 50% improvement from baseline in their Psoriasis Area and Severity Index (PASI) score (a PASI-50 response) after 16 weeks.

In this randomized 1:1 trial, approximately 110 patients will receive either a daily single capsule of EDP2939 or a matching placebo. Secondary endpoints include physician- and patient-reported psoriasis outcomes, as well as further safety evaluation. Let’s see if EDP2939 can help patients with moderate plaque psoriasis!

About Extracellular Vesicles (EVs)

EDP2939, Evelo’s first candidate for extracellular vesicles (EVs), is a natural lipid nanoparticle derived from the microbial strain of Prevotella histicola, just like EDP1815. Preclinical studies have demonstrated that these EVs can act in the small intestine, activating systemic regulatory T cells that have the power to reduce inflammation across the body.

About Evelo Biosciences

Evelo Biosciences is revolutionizing the way we view and treat inflammation. By developing a novel platform of orally delivered anti-inflammatory medicines acting on the small intestinal axis, SINTAX, Evelo has the potential to create therapies that are effective, safe, well-tolerated, and affordable to improve the lives of those living with inflammatory diseases.

Its product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles (EVs), with the potential to be effective in diseases such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease. With this new approach to treating inflammation, Evelo is paving the way for a new era of health and well-being.

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