Product Dev Landscape
Potential Platform to Treat Allergic Diseases
‘1104 was derived from a natural immune-regulatory protein, Mycobacterium tuberculosis Chaperonin 60.1, involved in resetting the immune system. It may provide long-term remission for many allergic diseases.
We are developing ‘1104 for the treatment of patients with eosinophilic esophagitis (EoE) and allergic disease.
Eosinophilic Esophagitis (EoE)
EoE is a progressive disease characterized by difficulty swallowing and gastric reflux. Roughly 180,000 children and adults in the US have EoE,1 and up to 80% of patients have secondary allergic conditions.2 Early disease control is critical to avoid thickening of the tissue of the esophagus.
There are no FDA-approved drug products for EoE, and 50,000 patients are unresponsive to available treatments, including long-term steroids. Patients may take proton pump inhibitors, but chronic frequent dosing often leads to poor compliance.
A placebo-controlled, first in human, Phase 13 clinical trial investigating ‘1104 in healthy volunteers and patients with mild asthma demonstrated that ‘1104 is safe at clinically relevant doses. A second Phase 1 multiple ascending dose (MAD) study in 18 healthy subjects showed that ‘1104 is safe and tolerable with no serious adverse events (SAEs).
A Phase 2 trial investigating ‘1104 as a potential treatment for patients with EOE is expected to start soon.
We are initiating a Phase 2 allergen sensitivity study to select the optimal indication for ‘1104 soon.
- Moawad FJ. Eosinophilic esophagitis: incidence and prevalence. Gastrointest Endosc Clin N Am. 2018;28(1):15-25.
- Wechsler JB, Bryce PJ. Allergic mechanisms in eosinophilic esophagitis. Gastroenterol Clin North Am. 2014;43(2):281-296.
- Immune Regulation Ltd. Immune Regulation announces positive results from Phase 1 clinical trial of IRL201104. https://revolobio.com/2019/12/10/immune-regulation-announces-positive-results-from-phase-1-clinical-trial-of-irl201104/. Published December 10, 2019. Accessed May 4, 2021.
- Pawankar R, Canonica GW, Holgate ST, Lockey RF, Blaiss MS, eds. WAO White Book on Allergy: Update 2013. Executive Summary. Milwaukee, WI: World Allergy Organization; 2013. https://www.worldallergy.org/UserFiles/file/ExecSummary-2013-v6-hires.pdf. Accessed May 4, 2021.