Revolo Biotherapeutics believes that it possesses the data necessary to continue developing a potential competitor to Dupixent. The biotechnology company was able to correlate its peptide with a “numeric reduction” on the primary outcome of a modest and brief phase 2a allergy trial. This gave the company the confidence to begin looking ahead to future research.
Revolo’s IRL201104 is designed to treat eosinophilic esophagitis (EoE), an inflammatory disorder that leads to inflammation of the esophagus and, in turn, can lead to chest discomfort and difficulty swallowing.
According to an analysis done by Global Data, the market for EoE in the U.S. is expected to expand at a compound annual growth rate (CAGR) of over 25%, reaching $1.5 billion in value by 2030. By contrast, in 2020, the market was valued at just over $156 million.
Although clinicians continue to see a need for novel medications, Sanofi and Regeneron have begun a commercial expansion in EoE that might make the indication the next major growth factor for Dupixent.
Still, Revolo wants to be able to meet the need for innovative drugs. On the basis of the top-line results from phase 2a, it is difficult to assess if it can. In this trial, 36 individuals who were currently experiencing active EoE were given either an intravenous injection of one of two doses of IRL201104 or a placebo once every week for a total of three weeks. The primary outcome that was evaluated by Revolo was the difference in eosinophil count after a period of four weeks.
EoE is caused by an accumulation of eosinophils, a type of white blood cell, in the esophagus. So, lowering the cell count should alleviate symptoms, a notion that hasn’t always been supported in clinical practice. Revolo stated that in the study, the team witnessed “a dose-dependent numeric reduction from baseline in the peak esophageal intraepithelial eosinophil count compared to the placebo group.”
In addition, the impact of the proposed drug on many other indicators, such as regulatory B and T cells, was investigated in this study. Revolo monitored growth in both types of regulatory cells, which are known to dampen immunological responses, and noted the results as a point of difference in comparison to other methods of treating EoE.
There are reasons to believe that IRL201104 will have different impacts than Dupixent and the other drug candidates that are now in phase 3, specifically cendakimab, which is being developed by Bristol-Myers Squibb, and APT-1011, being produced by Ellodi Pharmaceuticals. The asset that Revolo has is based on a naturally occurring immune-regulatory protein called Mycobacterium TB Chaperonin 60.1. This protein has been shown to have positive effects on certain types of allergic inflammation.
Clinical evidence provided by Sanofi and Regeneron that linked the blockbuster drug Dupixent to decreases in eosinophils and developments on a patient-reported indicator of swallowing trouble at Week 24 were the primary factors that led to the acceptance of Dupixent for the treatment of EoE last year. In the experiment being conducted by Revolo, the swallowing evaluation is listed as a secondary endpoint that will be examined after eight weeks. The biotech company has not yet disclosed any information on the endpoint.