Synedgen Completes IND-Enabling Studies for Two Parallel Programs for Lead Asset MIIST305
April 25 2024 - 2:00PM
Business Wire
- Parallel programs will advance MIIST305 in
ulcerative colitis (UC) and gastrointestinal acute radiation
syndrome (GI-ARS)
- Phase 1 clinical studies expected to begin in
2025
Synedgen, Inc., a biotechnology company targeting human
glycobiology to treat gastrointestinal diseases, today announced it
has completed IND-enabling studies for its lead candidate,
MIIST305. MIIST305 is being developed for two parallel programs, an
indication for ulcerative colitis (UC) and a medical countermeasure
for gastrointestinal acute radiation syndrome (GI-ARS). Within a
year, Synedgen plans to open an Investigational New Drug (IND)
application for MIIST305 and initiate a Phase 1 clinical study to
support both programs. Derived from Synedgen’s Multivalent Immune
Signaling Target (MIIST) platform, MIIST305 is an orally delivered,
gut-restricted, tissue regenerative drug candidate.
Synedgen was awarded a $4.4 million grant from the
Congressionally Directed Medical Research Program (CDMRP) to fund
some of MIIST305’s preclinical, IND-enabling studies. Previously,
MIIST305 demonstrated evidence of restoring innate gut barrier
function and early return to a healthy GI tract, both in murine
models of radiation exposure and UC. MIIST305 has an excellent
safety and toxicological profile. With CDMRP support, Synedgen has
now completed dose administration testing, pharmacokinetic (PK)
studies, IND-enabling Good Laboratory Practice (GLP) toxicology, a
pre-IND meeting with the FDA and safety pharmacology studies as
well as validated processes for chemistry, manufacturing, and
controls (CMC).
“The completion of IND-enabling activities represents a
significant milestone in our progress towards developing a
treatment option for UC patients, the civilian application for
MIIST305,” said Shenda Baker, PhD, President and CEO of Synedgen.
“We are grateful for the CDMRP funding that has enabled us to
complete preclinical studies of MIIST305, which could address an
unmet medical need for a drug capable of rapid induction and
sustained maintenance in ulcerative colitis. MIIST305 also holds
great potential as a GI-ARS medical countermeasure, with the
potential to reduce mortality after exposure to lethal ionizing
radiation. To date, we have had constructive conversations with the
FDA in pre-IND meetings for both MIIST305 programs, and we are
enthusiastic about the potential to advance both our UC and GI-ARS
programs into the clinic.”
In the U.S., UC is estimated to affect 214 per 100,000 people
(or approximately 700,000). The UC drug market was worth
approximately $7.5 billion worldwide in 2020, constituting 10% of
the total immunology market. With limited treatment options, high
rates of non-responsive or refractory patients, and frequent
disease flares, there is a large unmet need for new therapies.
“There is an urgent need for innovative therapies that target
the underlying disease, instead of just managing symptoms,
considering that less than 30% of patients with UC achieve
remission,” said Brian Feagan, MD, a gastroenterologist and
Professor of Medicine at the Schulich School of Medicine &
Dentistry in Ontario, Canada. “With its novel mechanism of action,
excellent safety profile, and potential for combination therapy,
MIIST305 could provide a much-needed therapy for the patients and
physicians dealing with UC.”
About MIIST
Synedgen’s Multivalent Innate Immune Signaling Target (MIIST)
platform targets the glycocalyx, a key to human innate immunity.
Historically an underappreciated target in drug development, the
glycocalyx is becoming more recognized as the key to intestinal
homeostasis. Developed with extensive peer-review and funding from
government partners, the MIIST platform is being used to advance a
diverse array of therapeutics promoting mucosal barrier protection
and regeneration. The Company is continuing to develop its GI-ARS
program with support from key partnering agencies in the United
States government.
About Synedgen
Synedgen, Inc. (Claremont, CA) is a biotechnology company
developing Multivalent Innate Immune Signaling Target (MIIST)
therapeutics that modulate and enhance the innate immune system.
The company’s lead development candidate is MIIST305, an oral,
glycocalyx targeted induction and maintenance therapy for
ulcerative colitis (UC). With US Government support, MIIST305 is
also being developed in parallel as a medical countermeasure (MCM)
for gastrointestinal acute radiation syndrome (GI-ARS). MIIST
technology has been validated with clinical trials in partnered
programs and extensively peer-reviewed through twenty-two (22)
National Institutes of Health grants and Department of Defense
contracts. Synedgen has an in-house GMP manufacturing facility. For
more information, please visit www.synedgen.com.
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Laurence Watts 619-916-7620 laurence@newstreetir.com