Last month, Evelo Biosciences announced its plans to proceed with a Phase III study of EDP-1815 for the treatment of psoriasis (PsO). GlobalData anticipates the trial to be initiated in the fourth quarter of next year. Evelo is a small, US-based biotech developer founded in 2015. The company currently has two drugs in clinical studies and four drugs in preclinical studies. Evelo’s main area of focus is inflammation, which the company aims to treat by developing oral small intestine-targeting medicines. To date, EDP-1815 has been the company’s most progressed candidate, as it is currently in late-stage development for plaque PsO and Covid-19, as well as being in Phase II development for atopic dermatitis.

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 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 colonising 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 a 50% improvement in PASI (PASI50) from baseline at the 16-week timepoint. In addition, safety data were comparable with those for placebo and consistent with what had previously been reported in a Phase Ib study. Based on this data, Evelo intends to enter a Phase III trial of EDP-1815 next year.

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. Considering that Evelo might need 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 branded biologics lose dominance. New therapies will, however, likely need to meet the 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.