Revolo Biotherapeutics Limited (“Revolo”) today announced new preclinical data demonstrating the potential of its lead allergic-disease treatment candidate, ‘1104, as a SL formulation. The data shows that when administered sublingually via a dissolvable tablet in a lung model of allergic disease, ‘1104 achieves comparable positive results across multiple inflammatory immune cells and other markers of allergic inflammation to those seen with SQ or IV injections of ‘1104.
Additionally, the data continues to demonstrate the differentiated upstream MOA of ‘1104, restoring immune homeostasis by impacting both the effector and regulatory arms of the immune system with a persistence of effect for multiple weeks.
Specifically, SL dosing of ‘1104 resulted in reduced inflammatory cell infiltration, including eosinophils and neutrophils, comparable to SQ and IV routes. SL dosing of ‘1104 also led to a reduction of key T2 cytokines and allergen specific immunoglobulin (Ig)E, similar to reductions seen with SQ and IV administration.
“If successfully translated to the clinic, a sublingual option could represent a breakthrough in the treatment landscape for people living with EoE and other allergic diseases,” said Kari Brown, M.D., Chief Medical Officer at Revolo. “The differentiated upstream MOA by which ‘1104 acts, alongside a favorable safety profile across multiple Phase 1-2 clinical studies and its potential flexibility in route of administration, highlights its potential use as a future first-line therapy.”
There is a strong need for additional treatment options for patients with EoE and other allergic diseases. Current therapeutics for EoE, the lead indication for ‘1104, include chronic subcutaneous monoclonal antibodies and oral options with significant safety considerations.
Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo Biotherapeutics, added,
“Following data announced earlier this year, which supports the development of a subcutaneous formulation of ‘1104, these positive oral results provide Revolo with an exciting path forward. As we look to the future, we will prioritize the SQ formulation of ‘1104, with plans to initiate a new Phase 2 study in EoE in 2025 and potentially atopic dermatitis. However, we will continue to gather data on the SL formulation in parallel to inform our future strategy, including ongoing discussions with strategic partners. Our goal is to provide people with chronic allergic conditions a new effective and convenient treatment option without the burden of limiting side effects.”