Revolo Biotherapeutics presents new data demonstrating long-lasting effect of ‘1104 in a food allergy model at the 2023 AAAAI annual meeting

Data demonstrates the potential of ‘1104 as an allergen-agnostic therapeutic for the treatment of food allergy

NEW ORLEANS, LA and CAMBRIDGE, England, February 28, 2023 – Revolo Biotherapeutics (“Revolo Bio” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that it has presented new preclinical data in an oral presentation at the 2023 American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting, which was held February 24-27 in San Antonio, Texas. The data demonstrate the long-lasting effect of ‘1104 in a food allergy model, including the reduction of anti-inflammatory markers and improvements in clinical scores, highlighting its potential as an allergen-agnostic therapeutic for the treatment of food allergy.  

“We are very pleased to continue to demonstrate the positive effect of ‘1104 in multiple allergic disease settings, including now in food allergy,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “The ability of ‘1104 to induce a long-term effect both at prophylactic and therapeutic doses highlights its potential as a much-needed option for food allergy patients who currently rely on chronic treatments that often lead to immunosuppression. We look forward to exploring the potential clinical utility of ‘1104 in food allergy as we advance our ongoing Phase 2a clinical studies in allergen sensitivity and eosinophilic esophagitis (EoE), for which we expect results in Q2 2023.”

Key data highlights:

  • ‘1104 attenuates the early anaphylactic allergic response in a model of ovalbumin-driven food allergy.
  • The effect, after both prophylactic and therapeutic dosing, is consistent across “clinical” symptoms (anaphylaxis score and body temperature) and relevant serum biomarkers of inflammation, such as key cytokines and chemokines (mMCP-1, OVA-IgE, IL-4, IL-5, IL-13, and Eotaxin).
  • Despite a short pharmacokinetic (PK) plasma half-life, ‘1104 shows a long pharmacodynamic (PD) effect of 13 days in this early allergic response model, which is consistent with the effect observed in previous models of late allergic response.

These studies evaluated ‘1104 at three doses (80ug/kg, 160ug/kg and 800ug/kg) administered every 2-3 days and also challenged with 5mg of ovalbumin (OVA) starting 14 days after sensitization until day 28. Symptoms scores, body temperatures, serum biomarkers (mMCP-1 (an indicator of mast cell activation) and Ova-IgE) and serum cytokines (IL-4, IL-5, IL-13 and Eotaxin) were evaluated at Day 21, 23, 25 and 28. Some mice dosed with 80ug/kg and 800ug/kg of ‘1104 were then re-challenged  and evaluated for these markers at 38 days after sensitization (i.e. 13 days after the last dose of ‘1104).  At all of these time points, ‘1104 was able to reduce anaphylaxis (symptom score, hypothermia), attenuate the increase in cytokines and IgE, and limit the activation of mast cells. These data indicate a long-term suppression of indices of anaphylaxis in this model.

About ‘1104

‘1104 is a first-in-class peptide derived from a natural immune-regulatory protein, mTB Chaperonin 60.1 that is involved in resetting the immune system. Revolo Bio is advancing ‘1104 through two Phase 2 trials: one in patients with eosinophilic esophagitis (EoE) and one in patients with allergen sensitivity, while exploring its potential for other allergic diseases.

Revolo Biotherapeutics

Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, reset the immune system to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1805 is a modified analogue of a key protein in immune function nearing initiation of a second Phase 2b clinical trial for moderate-to-severe rheumatoid arthritis and a Phase 2a clinical trial for an additional autoimmune indication. ‘1104 is a peptide derived from a natural immune-regulatory protein and has recently completed a Phase 2a clinical trial for patients with eosinophilic esophagitis (EoE) with data expected in Q2 2023. ‘1104 is also being evaluated in an ongoing Phase 2 clinical trial for allergic disease with data expected Q2 2023. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases.

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