Single dose of peptide reduces grass pollen allergic inflammation
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Key takeaways:
- The study involved 63 adults with seasonal allergic rhinitis.
- Treatment increased IL-10+ regulatory T and B cells.
- Key inflammatory and tissue remodeling gene levels normalized.
Patients experienced a rapid reduction in allergic inflammation caused by an intradermal grass pollen challenge after one dose of a first-in-class peptide, according to a press release from Revolo Biotherapeutics.
Known as ’1104, the peptide is derived from mycobacterium tuberculosis chaperonin 60.1, which is a natural immune-regulatory protein involved in resetting the immune system.
The 12-week, randomized, double-blind, placebo-controlled, parallel-design allergen challenge trial was designed to assess the immunologic mechanisms, safety and tolerability of treatment with ’1104 in adults with moderate to severe seasonal allergic rhinitis.
“This study used grass pollen allergy as a model to understand how ’1104 affects the immune system in patients with allergic disease and to further understand its potential as a differentiated treatment for these conditions,” Jonathan Rigby, MBA, CEO of Revolo Biotherapeutics, told Healio.
The 63 patients in the study received 8 mg of ’1104 or placebo and were challenged with grass pollen intradermally. The researchers measured the mean diameter of the intradermal challenge late-phase response 8 hours later. Other metrics were measured throughout the study period as well.
Treatment led to average wheal diameter surface area reductions of 23% with placebo and 40% with ’1104 after 8 hours with no adverse safety signals, according to the press release.
Treatment also was associated with a sustained increase in activated IL-10+ regulatory T (Treg) cells and IL-10+ regulatory B (Breg) cells, which the company called key regulatory immune cells that control allergic response and inflammation.
These increases in activated IL-10+ Treg and Breg cells persisted for at least 28 days but returned to baseline by week 12 with the absence of ongoing allergen exposure, according to the press release.
Further, treatment with ’1104 led to normalization of levels of key inflammatory and tissue remodeling genes that was sustained through the end of the 12-week trial.
Current medicines for allergic disease require frequent dosing without complete symptom relief in most cases, Rigby said.
“In this study, we found that ’1104 regulates the immune system only when there is inflammation induced by the presence of an allergen, restoring the immune system balance,” Rigby said.
“The data also reaffirm its potential to drive long-term disease remission, given its demonstrated sustained immune tolerance effects in a disease with continued allergen exposure,” he said.
In addition to previous research including a recent phase 2a study of the use of ’1104 in treating eosinophilic esophagitis (EoE), these findings support the peptide’s potential for treating multiple allergic diseases, the company said.
Revolo will launch a phase 2b trial for ’1104 in EoE in the first half of 2024 to explore further indications that could benefit from its novel immune tolerance mechanism of action, according to the company.