Anji Pharmaceuticals Acquires Late-Stage Clinical Asset and Readies for Ph3 Trials in Type 2 Diabetes with Chronic Kidney Disease

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anji Pharmaceuticals, Inc. (“Anji” or “the Company”) today announced the
acquisition of global development rights for a novel delayed-release
formulation of metformin (Metformin DR). Originally developed by Elcelyx
Therapeutics, Metformin DR is an investigational product designed to
target metformin delivery to the lower small intestine. In a recent
Phase 2b study with 571 enrolled subjects, Metformin DR afforded robust
glucose lowering with significantly reduced systemic exposure,
demonstrating a tolerability profile potentially suitable for type 2
diabetes patients who are currently restricted or contraindicated to
metformin use (due to impaired renal function) or those with poor
tolerance to other metformin regimens. Having received input from the
FDA on its clinical development plan, Anji plans to initiate a pivotal
Phase 3 study in patients with Chronic Kidney Disease (Stage 3b/4) later
this year.

“We are extremely excited to add Metformin DR to our late-stage clinical
pipeline,” noted Dr. Dan Meyers, Chief Medical Officer of Anji. “We
recognize the importance of new treatment options for patients with type
2 diabetes with advanced kidney disease who cannot take metformin due to
risk of lactic acidosis. Metformin DR has the potential to give CKD
patients access to a first-line therapy that has been the mainstay for
decades.”

“We are very pleased to see the continued progression of Metformin DR
through our partnership with Anji,” comments Alain Baron, MD, president
and Chief Executive Officer of Elcelyx. “Finding a science-driven
organization that recognized the tremendous potential of gut-specific
delivery of metformin was crucial to our program strategy. We are
excited to work with Anji on the Ph3 global program of Metformin DR and
accelerate its availability to patients in need of better glycemic
control.”

About Metformin DR

Metformin DR has been studied in nine previous clinical trials including
an earlier Phase 2 study where various doses of Metformin DR were
compared with placebo or Metformin Extended Release (XR) in subjects
with type 2 diabetes. In that study, Metformin DR exhibited
statistically significant and sustained reductions in fasting plasma
glucose over 12 weeks compared with placebo. Metformin DR was well
tolerated at all doses tested.

About Anji Pharmaceuticals

With its platform of using human genetic data to drive target selection,
Anji has built a robust pipeline of clinical assets to treat
cardiometabolic disorders. Anji has recruited a nimble and experienced
clinical team to advance novel treatment paradigms, especially in the
areas of gut and lipid metabolism. Anji’s pipeline reflects their
strategy to rapidly bring life-changing therapies to patients and
synchronize the clinical development of innovative medicines across the
world. For more information, visit anjipharma.com.

About Elcelyx Therapeutics

Elcelyx Therapeutics is developing pharmaceutical agents designed to
modulate the gut neuroendocrine system including the L-cell, which when
activated is responsible for release of glucoregulatory hormones.
Metformin Delayed Release (Metformin DR), the first product of this
type, is designed to deliver metformin to the gut instead of
systemically, thereby reducing bioavailability while still achieving
efficacy. Metformin DR development arose from Elcelyx’s discovery that
the site of action for metformin, the most commonly prescribed diabetes
drug, is in the gut. Given its targeted delivery and low systemic
bioavailability, Metformin DR may provide a treatment option for type 2
diabetes patients who are currently contraindicated due to renal
impairment or who cannot tolerate existing metformin formulations. For
more information, visit elcelyx.com.

Contacts

Michael Serrano-Wu, Ph.D. (617) 514-7169