ImmunogenX and Mayo Clinic Celiac Disease Study Published in Gastroenterology

Convincing evidence of efficacy and protection demonstrated again

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–ImmunogenX is pleased to report the successful completion of the CeliacShield™ trial (NCT03585478), focused on treating celiac disease (CeD) patients, will be published in the premier journal Gastroenterology and is entitled:

Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients with Celiac Disease Exposed to a Gluten Challenge

doi.org/10.1053/j.gastro.2022.07.071

This work was performed at Mayo Clinic under Principal Investigator Joseph Murray, MD and resulted in:

• Confirmed findings of a prior European study (NCT01255696) demonstrating that latiglutenase protects patients from mucosal damage induced by dietary gluten.
• Used a celiac disease specific patient reported outcomes (PRO) instrument to demonstrate that latiglutenase also protects against adverse clinical effects of gluten consumption.
• First-time clinical-trial use of a gluten-immunogenic peptide (GIP) in urine assay to demonstrate ~95% elimination of gluten in the stomach (p < 0.0001) by latiglutenase.

Peter HR Green, MD of Columbia University remarks, “As an independent observer for this trial and a site Principal Investigator for another latiglutenase trial, I am happy to state that latiglutenase offers the potential for significant improvement in the pain and suffering and quality of life of celiac disease patients. These patients, despite strict adherence to a gluten-free diet, remain exposed to gluten in everyday life and suffer the consequences despite their best dietary efforts.”

Jack Syage, PhD and CEO of ImmunogenX, states, “We are excited by the continued success of latiglutenase as a leading therapeutic candidate for celiac disease patients as an adjunct to a gluten-free diet. Our mission to improve the lives of celiac disease patients is inspired by members of our team who are afflicted with this disease and are the driving force to achieving success to benefit all others.“

This clinical trial was sponsored by the National Institutes of Health’s (NIH) National Center for Complementary and Integrative Health (NCCIH).* Further information can be found at Celiacshield.com.

* The content of this news release is solely the responsibility of ImmunogenX and does not necessarily represent the official views of the National Institutes of Health.

About ImmunogenX

ImmunogenX, Inc. is a clinical-stage biopharmaceutical company founded in 2013 and is supported by a team of world-renowned clinicians, scientists and advisors in celiac disease research. The company is developing latiglutenase (IMGX003) for celiac disease therapy. ImmunogenX is also developing a diagnostic tool for celiac disease management (CypCel™) as a minimally-invasive monitor of villus health to follow the state of recovery of a celiac patient adhering to a gluten-free diet or other treatment. www.immunogenx.com

Contacts

Matthew Dickason, MBA

Chief Operating Officer

(949) 679-0900

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