Revolo Presents New Preclinical Data Validating '1104 for Atopic Dermatitis

Revolo Biotherapeutics Limited has announced promising new data from preclinical studies highlighting the potential of its lead clinical asset, ‘1104, as a treatment for atopic dermatitis (AD). The findings validate the broad clinical applicability of ‘1104, showcasing its ability to significantly impact various measures of skin disease and a wide range of inflammatory cytokines and chemokines linked to AD pathology.

In a chronic allergen-driven murine model of AD, ‘1104 demonstrated a substantial reduction in skin pathology indicators and serum biomarkers of AD. These improvements brought levels close to those seen in naïve control individuals and were comparable to those treated with the anti-inflammatory drug dexamethasone. Specific reductions were observed in skin thickness, erythema, and skin erosion. Moreover, ‘1104 lowered 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. It also affected non-Th2 cytokines like tumor necrosis factor (TNF) alpha, IL-1 beta, interferon (IFN) gamma, and IL-17.

Additionally, ‘1104 reduced key serum biomarkers typically associated with AD pathology, including chemokine ligand 17 (CCL-17), CCL-22, and the Th2 cytokine IL-31. IL-31 is particularly noted for its association with pruritus (itching) and disruption of the skin barrier.

Kari Brown, M.D., Chief Medical Officer at Revolo, emphasized the unique and impressive ability of ‘1104 to impact a wide range of inflammatory mediators linked with allergic disease while addressing disease pathology. Brown noted that these data support the initiation of a clinical trial evaluating ‘1104 in patients with atopic dermatitis. Current treatments often target inflammation after it occurs, but ‘1104 aims to address the underlying inflammatory response, potentially offering a more effective treatment option for patients.

Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo, highlighted the company's commitment to developing a product with increased efficacy and dosing convenience for patients with allergic diseases. The compelling preclinical data on atopic dermatitis further validate the potential of ‘1104 across various allergic conditions, including both Th-2 and non-Th2 diseases. Bryan expressed anticipation for the upcoming clinical trial in AD and the continued development of ‘1104, building on positive data from a completed Phase 2 study in eosinophilic esophagitis.

‘1104 is a first-in-class peptide that plays a role in restoring immune homeostasis, impacting both regulatory and effector arms of the immune system. Revolo has advanced ‘1104 through two Phase 2a trials, one in patients with eosinophilic esophagitis (EoE) and another in those with allergen sensitivity. The company plans to develop a commercially differentiated subcutaneous dosage form for clinical studies in EoE and other type 2 allergic conditions.

Revolo Biotherapeutics is focused on developing therapies that act upstream in the immune cascade for treating autoimmune and allergic diseases without the immune suppression seen with current therapies. Their drug candidates, ‘1805 and ‘1104, aim to restore immune homeostasis and prevent the chronic pro-inflammatory immune response that leads to autoimmune or allergic diseases. This mechanism of action provides a platform for developing treatments for multiple autoimmune and allergic conditions.

Revolo looks forward to advancing ‘1104 in clinical trials and exploring its potential to offer more effective treatments for various allergic diseases.