In a news release from June 23, 2021, Revolo Biotherapeutics (“Revolo”) shared that the FDA approved an Investigational New Drug (IND) application for the company’s ‘1104 peptide treatment. Altogether, ‘1104 is designed to treat patients with eosinophilic esophagitis (EoE).
‘1104
The Investigational New Drug (IND) application is submitted for a drug developer (in this case, Revolo) to receive FDA exemption to transport investigational drugs across state lines. Typically, this is sought prior to the initiation of human clinical trials. With the IND approval, Revolo may now move forward with a Phase 2 clinical trial.
Currently, there are no approved treatment options for patients with EoE. Rather, patients manage their conditions using diet modifications, immune suppressants, and steroid treatments. Thus, if effective, ‘1104 could offer a more effective and targeted treatment option. But what exactly is ‘1104? This first-in-class peptide is derived from mTB Chaperonin 60.1, an immune-regulatory protein. ‘1104 is designed to work by effectively “resetting” the immune system and preventing the inflammatory response inherent in EoE. Additionally, Revolo hopes that ‘1104 may reduce inflammation and other EoE symptoms without causing immune suppression.
Eosinophilic Esophagitis (EoE)
Eosinophilic esophagitis (EoE) is a chronic allergic and immune system disorder which affects the esophagus, or the fleshy tube which connects your mouth to your stomach. In patients with EoE, excess eosinophils (a type of white blood cell) accumulate in the esophagus. Normally, eosinophils play a role in immune response. However, excess eosinophils suggest some sort of allergic reaction. Typically, this accumulation acts as a response to some stimuli, such as food, acid reflux, or allergens. As a result, esophageal tissue is damaged, causing a host of health issues. EoE is slightly more common in males than females. An estimated 180,000 Americans have EoE. Additionally, many patients also experience other allergic conditions, such as eczema or asthma.
Symptoms associated with EoE vary in children and adults. In adult patients, symptoms may include:
- Difficulty swallowing
- Food impaction (food getting stuck in the throat)
- Centrally located chest pain
- Food regurgitation
Alternately, symptoms in children include:
- Difficulty swallowing
- Nausea and vomiting
- Abdominal pain
- Food impaction
- Appetite loss
- Failure to thrive
- Difficulty feeding or eating
