GlobalData anticipates that Evelo Biosciences’ Phase III study of EDP-1815 for the treatment of psoriasis (PsO) will be initiated in Q4 2023. The leading data and analytics company notes that EDP-1815 has been the company’s most progressed candidate, as it is currently in late-stage development for plaque PsO and COVID-19, and is in Phase II development for atopic dermatitis.

Chris Pilis, Immunology Analyst at GlobalData, comments: “Evelo’s EDP-1815 is an oral formulation consisting of hundreds of billions of single-strain microbes called monoclonal microbials, which displayed positive data in the company’s Phase IIb clinical trial in PsO. These strains are selected for their ability to engage cells in the small intestine, which can in turn reprogram the immune system to enter either a pro- or an anti-inflammatory state.

“The effects of monoclonal microbials are dose-dependent, and each modulates multiple clinically validated pathways. After exerting their effect, monoclonal microbials are excreted by the body without colonizing the lumen.

“Evelo’s EDP-1815 Phase IIb trial produced a statistically significant reduction in the Psoriasis Area and Severity Index (PASI) score, as measured by the proportion of patients achieving at least 50% improvement in PASI (PASI50) from baseline at the 16-week timepoint. Moreover, safety data were comparable to placebo and consistent with what was previously reported in a Phase Ib study. Based on this data, Evelo intends to enter a Phase III trial of EDP-1815 in 2023.”

Historically, the PsO market has been dominated by injectable biologics, which will face a major threat in the future from the launch of biosimilars. The plethora of existing PsO drugs limits how much the market can continue to grow in the next ten years.

Pilis continues: “Considering that Evelo might have to conduct at least two large Phase III trials on EDP-1815 for PsO, the competitive landscape might have shifted significantly by the time the product makes it to market. GlobalData anticipates that new drug manufacturers that have therapies with novel mechanisms of action such as Evelo will be able to gain traction as the branded biologics lose dominance.

“However, new therapies will likely need to meet rigorous clinical standards set by the many existing treatments. GlobalData expects the PASI75 endpoint to be the lower threshold moving forward in order to demonstrate adequate efficacy. Primary research conducted by GlobalData suggests that patients may easily adopt a promising first-in-class, microbiome-targeting drug such as EDP-1815, but Evelo will have to convince regulatory authorities and payers to supports its candidate in the PsO market.”