Revolo Biotherapeutics Limited (“Revolo”) today announced new data from preclinical studies that validate atopic dermatitis (AD) as a target indication for the Company’s lead clinical asset, ‘1104. The data reinforces the broad clinical applicability of ‘1104, through a novel upstream mechanism of action (MOA), demonstrating its impact across skin disease measures and a wide range of inflammatory cytokines and chemokines associated with AD pathology.
Key results include:
- In a chronic allergen-driven murine model of atopic dermatitis, ‘1104 significantly reduced skin pathology indicators and serum biomarkers of AD to levels close to naïve control individuals and comparable to positive control individuals treated with the anti-inflammatory dexamethasone.
- This includes a reduction in skin thickness and a reduction of skin pathology indicators such as erythema and skin erosion.
- ‘1104 reduced allergen-specific immunoglobulin E (IgE) levels and key T helper 2 (Th2) cytokines in serum, such as interleukin 4 (IL-4), IL-5 and IL-13, in addition to non-Th2 cytokines like tumor necrosis factor (TNF) alpha, IL-1 beta, interferon (IFN) gamma, and IL-17.
- ‘1104 also reduced key serum biomarkers classically associated with AD pathology such as chemokine ligand 17 (CCL-17), CCL-22, and Th2 cytokine IL-31, which is associated with pruritus and disruption of the skin barrier.
“The ability of ‘1104 to affect a broad range of inflammatory mediators associated with allergic disease, while also impacting disease pathology, is both unique and impressive,” said Kari Brown, M.D., Chief Medical Officer at Revolo. “These new data support the initiation of a clinical trial evaluating ‘1104 in patients with atopic dermatitis. ‘1104 has the potential to offer patients a treatment that addresses the underlying inflammatory response, rather than just targeting inflammation after it occurs, which differentiates it from current treatments.”
Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo, added, “At Revolo, our priority has been to develop a product for patients with allergic diseases that can offer increased efficacy and dosing convenience. This compelling dataset in a preclinical model of atopic dermatitis is yet another convincing validation of the potential that ’1104 has across an array of allergic diseases, including Th-2 and non-Th2 conditions. We look forward to evaluating ‘1104 in a new clinical trial in AD and continuing to build on the positive data shown in the completed Phase 2 study of ‘1104 in eosinophilic esophagitis.”
About ‘1104
‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through two Phase 2a trials: one in patients with eosinophilic esophagitis (EoE) and one in patients with allergen sensitivity while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions.
