ColonaryConcepts Initiates Phase 1 Study of New Approach to Treating Chronic Constipation

Edible bar-based formulation of PEG-3350 extends company’s work in
developing patient-friendly colonoscopy prep to new indication

NEWTON, Mass.–(BUSINESS WIRE)–#colonoscopy_prep–ColonaryConcepts, LLC today announced the start of an open label Phase
1b clinical trial in patients with chronic idiopathic constipation
(CIC). The company’s experimental treatment, designated “C-bar,” is a
solid-form edible bar in a range of palatable flavors that delivers
PEG-3350, a well-characterized osmotic laxative. The C-bar is designed
to offer patients a more convenient, portable, and palatable daily dose
of active ingredient, in chewable form.

“As gastroenterologists, we know how uncomfortable and painful CIC can
be, and are committed to exploring new, effective forms of treatment
that make managing CIC easier,” says Corey Siegel, M.D., a
ColonaryConcepts co-founder and Director of the Inflammatory Bowel
Disease Center at the Dartmouth-Hitchcock Medical Center (Lebanon, NH)
and Associate Professor of Medicine at The Geisel School of Medicine at

ColonaryConcepts’ Chronic Constipation Study is an open-label,
proof-of-concept, Phase 1b study to assess the safety and effectiveness
of a daily dose of C-Bar in up to 25 adult male and female subjects with
CIC who are currently managing their symptoms with a single daily dose
of MiraLAX® (polyethylene glycol). The C-bar technology – integrating
the active laxative ingredient within a solid-form, edible bar – was
most recently deployed as part of ColonaryConcepts’ most
advanced investigational product: the ECP Colon Prep kit, which has just
successfully completed
a Phase 2 trial

As part of the study, patients will consume one daily dose of 17 grams
of PEG-3350 in a single C-bar each day for two weeks, and record their
experience managing their symptoms. The trial is being conducted at the
Investigative Clinical Research site in Annapolis, Maryland, under the
direction of Principal Investigator Michael Epstein, M.D. Key endpoints
for this study are effectiveness, patient tolerability and safety.
ColonaryConcepts expects to use the results from this study to plan a
Phase 2 trial in CIC, expected to begin later in 2016.

“We believe we can simplify the steps required for patients to take
their prescription, make it far more palatable, and ultimately, more
effective,” comments Joshua Korzenik, M.D., ColonaryConcepts co-founder,
faculty member at Harvard Medical School and the Director of Brigham and
Women’s Hospital Crohn’s and Colitis Center. “Our deep patient
experience tells us that there’s a real demand for a better approach,
especially as the incidence of constipation escalates.”

About Chronic Idiopathic Constipation

More than 50 million prescriptions are written annually in the United
States alone to treat some form of constipation. Chronic idiopathic
constipation (CIC), characterized by infrequent and difficult passage of
stool over 12 non-consecutive weeks within a 12-month period, afflicts
an estimated 14% – 16% of the adult population globally (and an
estimated 35 million U.S. patients annually, according to the American
Gastroenterological Association). While several FDA-approved products
are currently available for patients suffering from CIC, studies confirm
that patient experience is unsatisfying: as many as 50% report
ineffective symptom relief.

About ColonaryConcepts, LLC

ColonaryConcepts, LLC is headquartered in Newton, MA, and is committed
to developing patient-centric innovations that improve gastrointestinal
health. Their physician-led product development team includes
Board-certified gastroenterologists, food scientists, pharmaceutical
development experts, culinary research chefs, and product design
strategists. For more information about ColonaryConcepts, LLC, please

MiraLAX® is a registered trademark of Bayer Corporation.

Certain statements herein may be forward-looking and involve risks
and uncertainties. Such forward-looking statements involve assumptions,
known and unknown risks, uncertainties and other factors which may cause
the actual results, performance or achievements of ColonaryConcepts, LLC
to be materially different from any future results, performance, or
achievements expressed or implied by the forward-looking statements.
Such potential risks and uncertainties include, without limitation, that
the company will not be able to commercialize its future products, that
the FDA will not approve the initiation of the Company’s clinical
programs or provide market approval of the company’s products, the
Company’s ability to raise capital when needed, the Company’s ability to
complete the development of its planned products, the Company’s ability
to manufacture its products, the impact of government regulations,
patent protection on the Company’s proprietary technology, product
liability exposure, uncertainty of market acceptance, competition,
technological change, and other risk factors. The Company undertakes no
obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events, or otherwise.


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