Synedgen Completes IND-Enabling Studies for Two Parallel Programs for Lead Asset MIIST305

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.