Revolo Biotherapeutics thinks it has the data to keep advancing a would-be challenger to Dupixent. In a small, short phase 2a allergy trial, the biotech linked its peptide to a “numeric reduction” on the primary endpoint, emboldening it to start looking forward to further development.
The disease targeted by Revolo’s IRL201104, eosinophilic esophagitis (EoE), is an allergic condition that drives inflammation of the esophagus that can cause chest pain and make it hard for people to swallow. Sanofi and Regeneron are currently in the early stages of a commercial expansion in EoE that could make the indication the next big Dupixent growth driver, but physicians continue to see a need for new drugs.
Revolo wants to meet that need. Whether it can is hard to say based on the top-line phase 2a data. The study randomized 36 adults with active EoE to receive an intravenous hit of one of two doses of IRL201104 or placebo once a week for three weeks. Revolo’s primary endpoint looked at the change in eosinophil count after four weeks.
Eosinophils, a type of white blood cell, drive EoE when they build up in the esophagus. Reducing levels of the cells should therefore improve symptoms, although that theory hasn’t always held up in the clinic. Revolo saw “a dose-dependent numeric reduction from baseline in the peak esophageal intraepithelial eosinophil count compared to the placebo group.”
The study also assessed the effect of the drug candidate on other markers, including regulatory B cells and regulatory T cells. Revolo tracked increases in both types of regulatory cell, which suppress immune responses, and cited the data as a point of differentiation versus other approaches to treating EoE.
There are reasons to think IRL201104 will have different effects than Dupixent and the two drug candidates that are in phase 3, namely Bristol Myers Squibb’s cendakimab and Ellodi Pharmaceuticals’ APT-1011. Revolo’s asset is based on a natural immune-regulatory protein, Mycobacterium tuberculosis Chaperonin 60.1, which has beneficial effects in models of allergic inflammation.
Sanofi and Regeneron won approval for Dupixent in EoE last year on the strength of clinical data linking the blockbuster drug to reductions in eosinophils and improvements on a patient-reported measure of difficulty swallowing at Week 24. Revolo’s trial lists the swallowing assessment as a secondary endpoint measured after eight weeks. The biotech is yet to share data on the endpoint.