Jonathan Rigby, MD, President, Group CEO, and Board Member at Revolo Biotherapeutics, discusses the approval of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate the drug, ‘1104, in a phase 2 trial for eosinophilic esophagitis (EoE).
EoE is a chronic, allergic inflammatory disease that is characterized by the buildup of eosinophils in the lining of the esophagus. Patients with EoE often experience difficulty feeding, poor weight gain, and trouble swallowing. Currently, there is no approved treatment specifically for EoE. Standard of care includes steroids, which require frequent dosing and are often associated with unwanted side effects, such as immune suppression.
As Dr. Rigby explains, the study is set to begin recruiting patients in fall 2021. It will be a double-blind, randomized, placebo-controlled study with 3 arms, each with 12 participants. One arm will receive placebo, one arm will receive a lower dose of ‘1104, and the final arm will receive a higher dose of ‘1104. Participants will be given their allotted dose once a week for 3 weeks and will receive an endoscopy and esophageal biopsy at week 4. At week 6, there will be a follow-up and participants will complete the study at week 8.
‘1104 is a peptide derived from mTB Chaperonin 60.1, an immune-regulatory protein.
To learn more about EoE and other rare autoimmune disorders, visit checkrare.com/diseases/autoimmune