ImmunogenX Initiates Phase 2 Trial for its Lead Therapeutic and Diagnostic Candidates Latiglutenase and CypCel

March 14, 2019 Off By BusinessWire

Both technologies address unmet needs for patients with celiac disease

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–ImmunogenX is pleased to announce the initiation of a Phase 2 clinical
trial (named Celiac Shield™), sponsored by the National Institutes of
Health’s (NIH) National Center for Complementary and Integrative Health
(NCCIH), to be conducted at the Mayo Clinic in Rochester, MN. The trial
will test the safety and efficacy of the company’s lead therapeutic
candidate Latiglutenase for the protection of intestinal health and the
reduction of symptoms in the presence of a 6 week gluten challenge
treatment period. Key endpoints include: (i) intestinal health measured
by villous height to crypt depth ratio (Vh:Cd) from a biopsy at the
beginning and end of the treatment period, (ii) symptom response
utilizing a daily diary measuring the severity of 6 gluten-induced
symptoms, and (iii) intestinal health as measured by the diagnostic
method CypCel™, which uses simvastatin as a biomarker for villous
degradation. Urine samples will also be collected periodically to
measure gluten content for the placebo vs. latiglutenase arms during the
gluten challenge period. This work builds off of positive results
reported for Latiglutenase (Syage et al. Dig. Dis. & Sci. 2017) and for
CypCel (Moron, Am J Gastroenterol 2013). Further information can be
found on celiacshield.com.

The Co-Principle Investigators on the project are Joseph A. Murray MD of
the Mayo Clinic and Jack A. Syage PhD of ImmunogenX. These investigators
have worked together on a previous trial that focused on the CypCel
diagnostic for disease management.

“This trial represents an exciting opportunity to test our therapeutic
drug Latigutenase alongside our diagnostic disease management tool
CypCel. Though these are independent developments, and not companions,
the opportunity to run a controlled gluten-challenge trial allows us to
test both candidates simultaneously,” states Jack Syage PhD, CEO of
ImmunogenX. “We are extremely grateful to the NIH for recognizing the
importance of this work and for providing essential funding for celiac
disease research.”

About ImmunogenX

ImmunogenX (a subsidiary of Immunogenics LLC) is a clinical-stage
biotherapeutics 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 for celiac disease
therapy. ImmunogenX is also developing a minimally-invasive diagnostic
tool for celiac disease management (CypCel™) based on a clinically
relevant metabolic marker compound that can assess the state of recovery
of a celiac patient adhering to a gluten-free diet or other treatment.
For food safety, ImmunogenX is pioneering advanced mass spectrometry
methods to identify and measure physiologically relevant gluten peptide
sequences found in wheat, barley, and rye.

www.immunogenx.com