In addition to collaborating with traditional
healthcare providers, Gelesis will leverage Ro’s nationwide
telehealth services to make Plenity available to patients who don’t
have an established healthcare provider or prefer a remote
interaction
Ro provides a personalized end to end
telehealth experience from medical diagnosis to the home delivery
of prescription and OTC products
Plenity will be the only weight management
treatment available through Ro’s digital clinics as Ro expands to
treat new conditions on its platform
Gelesis, a biotechnology company developing a novel hydrogel
platform technology to treat obesity and other chronic diseases
related to the gastrointestinal (GI) tract, and Ro, a leading U.S.
telehealth provider, announced today they will partner to offer
high-quality remote care dedicated to weight management and
prescription fulfillment of Plenity. Ro’s telehealth services will
complement traditional live interactions to ensure people seeking
healthcare provider guidance for weight loss will have easy access
to multiple options. Through the Gelesis-Ro partnership, Plenity
will be the first FDA-cleared weight management aid and first
primary care product to launch with both traditional healthcare
provider and telehealth services, making Plenity available to
patients nationwide.
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the full release here:
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Plenity, an orally administered, non-systemic and non-stimulant
aid to weight management, was recently cleared for use by the FDA
in adults with a Body Mass Index (BMI) of 25–40 kg/m2, when used in
conjunction with diet and exercise. It is the only prescription
weight management product indicated for use by overweight adults
with a BMI as low as 25 kg/m2, making it available for the largest
number of adults affected by overweight and obesity of any
prescription weight-management aid.
Ro currently powers digital health clinics that provide a
personalized end to end telehealth experience from medical
diagnosis to the delivery of prescription and over-the-counter
products. Plenity will be the only weight management treatment
available through Ro’s digital clinics as the company expands to
treat new conditions on its platform. Ro’s portfolio currently
includes products for men’s and women’s sexual health, smoking
cessation and insomnia.
Obesity is a chronic progressive disease resulting from multiple
environmental and genetic factors. Because of the disease
complexity, there are numerous therapeutic and social challenges
facing individuals seeking assistance to achieve a healthier
weight. There are also limited safe and effective prescription
options to treat adults who are overweight but do not meet the
clinical threshold for obesity.
“Our current healthcare system is ill-equipped to assist the
millions of patients seeking to manage their weight, especially
starting at an overweight BMI of 25,” said Caroline Apovian, M.D.,
FACP, FACN, FTOS, professor of medicine and pediatrics in the
Section of Endocrinology, Diabetes, Nutrition and Weight Management
at Boston University School of Medicine and outgoing president of
the Obesity Society. “It is important to support effective
interactions between patients and their physicians regarding weight
management while providing new modalities of access to care for
patients who do not have an established healthcare provider or for
those who prefer a different type of interaction.”
Through Ro’s telehealth platform, adults will have access to
physicians trained in weight management support. Those interested
in learning if Plenity is a safe and appropriate treatment for them
can seek care through an online doctor’s visit dedicated to weight
management. If it is determined that an individual should be seen
in person for follow-up care or is better suited for another course
of treatment, the provider will recommend that they visit their
primary care provider or a specialist. Adults who receive a
prescription for Plenity through Ro’s platform will have access to
unlimited follow up communication with their physician at no
additional cost and will be provided with educational resources and
lifestyle recommendations. Ro can also keep a patient's in-person
provider updated on their treatment plan at the patient's request
to ensure continuity of care.
“Through the millions of patient-physician interactions
facilitated on our platform, physicians have seen the dramatic and
rippling impact of weight-related health issues firsthand,” said
Zachariah Reitano, co-founder and chief executive officer of Ro.
“Prior to this point, safe and effective treatment options for
weight management were limited and patients have faced significant
barriers to accessing high-quality care—whether that’s due to
stigmatization, cost or geography. Through this unique partnership,
Ro will provide high-quality, innovative treatment for weight
management, deliver Plenity straight to a patient’s door, and
maintain unrivaled care on one seamless platform. Together, we can
have a profound impact on how patients and physicians tackle this
serious and pervasive health challenge.”
“Our partnership with Ro reflects our shared vision of improving
access for patients in all corners of the country, including those
who may not feel comfortable talking to their primary care
physician about weight management,” said David Pass, Pharm.D.,
Gelesis head of commercial and chief operating officer. “The
objective remains simple: give people more choices, more support
and more power to manage their weight. We believe Ro is uniquely
suited to provide telehealth services that enable more individuals
to access the high-quality care they need, providing an additional
path to treatment and support for the complex, chronic health
conditions of overweight and obesity.”
Gelesis retains worldwide sales and marketing rights for Plenity
and, since FDA clearance, has secured close to $100 million in new
capital to support the U.S. commercial launch. Gelesis initiated an
early experience program as part of its targeted U.S. launch of
Plenity earlier this year and expects that Plenity will be
available in limited supply through healthcare providers and Ro’s
digital health clinics in the second half of 2020. In parallel, the
Company has been expanding its commercial manufacturing
capabilities and will continue to add capacity to meet demand.
About PLENITY™ PLENITY is an oral, non-systemic,
superabsorbent hydrogel which has received FDA clearance as an aid
in weight management in overweight and obese adults with a BMI of
25–40 kg/m2, when used in conjunction with diet and exercise. It is
made by cross-linking two naturally derived building blocks,
modified cellulose and citric acid, that create a three-dimensional
matrix. PLENITY particles rapidly absorb water in the stomach and
homogenously mix with ingested foods. Rather than forming one large
mass, it creates thousands of small individual gel pieces with the
elasticity (firmness) of solid plant-based foods (e.g., vegetables)
without caloric value. The PLENITY hydrogel increases the volume
and elasticity of the stomach and small intestine contents and
induces a feeling of fullness and satiety. Once it arrives in the
large intestine, the hydrogel is partially broken down by enzymes
and loses its three-dimensional structure along with most of its
absorption capacity. The released water is reabsorbed in the large
intestine, and the remaining cellulosic material is eliminated
through the body’s natural digestive processes. PLENITY is
considered a medical device because it achieves its primary
intended purpose through mechanical modes of action consistent with
mechanobiology constructs. For more information, visit
myplenity.com.
Important Safety Information
- PLENITY is contraindicated in patients who are pregnant or are
allergic to cellulose, citric acid, sodium stearyl fumarate,
gelatin or titanium oxide.
- PLENITY may alter the absorption of medications. Read Sections
6 and 8.3 of the Instructions for Use carefully.
- Avoid use in patients with the following conditions: esophageal
anatomic anomalies, including webs, diverticuli, and rings;
suspected strictures (such as patients with Crohn’s disease); or
complications from prior gastrointestinal (GI) surgery that could
affect GI transit and motility.
- Use with caution in patients with active GI conditions such as
gastro-esophageal reflux disease (GERD), ulcers or heartburn.
- Overall, the most common treatment related adverse events
(TRAEs) were GI-related with 38% of adults in the PLENITY group and
28% of adults in the placebo group.
- The overall incidence of adverse events (AEs) in the PLENITY
group was no different than the placebo group.
Rx Only. For the safe and proper use of PLENITY, refer to the
Instructions for Use.
About Gelesis Gelesis is developing a novel hydrogel
platform technology to treat overweight and obesity and chronic
diseases related to the GI pathway. Gelesis’ proprietary approach
is designed to act mechanically in the GI pathway to potentially
alter the course of certain chronic diseases. In April 2019,
Gelesis received FDA clearance for its lead product candidate,
Plenity™, as an aid for weight management in overweight and obese
adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in
conjunction with diet and exercise. Gelesis anticipates Plenity
will be available by prescription in the U.S. in the second half of
2020. Additionally, Gelesis is developing its second
investigational candidate, Gelesis200, a hydrogel optimized for
weight loss and glycemic control in patients with type 2 diabetes
and prediabetes. Novel hydrogel mechanotherapeutics based on the
Gelesis platform technology are also being advanced in other GI
inflammatory conditions, such as non-alcoholic steatohepatitis
(NASH) and Chronic Idiopathic Constipation (CIC).
The Gelesis executive and advisory team includes some of the
world’s leading experts in obesity, materials science, chronic
disease research, and commercialization. Gelesis was co-founded by
PureTech Health (LSE: PRTC), a clinical-stage biotechnology company
dedicated to discovering, developing and commercializing highly
differentiated medicines for devastating diseases. For more
information, visit gelesis.com or connect with us on Twitter
@GelesisInc.
About Ro Ro is a patient-driven healthcare company that
puts you in control of your health. We’re patients, just like you,
building technology to make healthcare accessible, affordable, and
maybe even enjoyable. Today, we enable you to connect with a doctor
and get treatment when and where you need it. Tomorrow, we aspire
to be your first call for all your healthcare needs. Ro powers
three digital health clinics — Roman, Rory and Zero — providing a
personalized end to end telehealth experience from diagnosis to
delivery. Ro’s platform has facilitated over 3 million
doctor-patient interactions through its secure healthcare portal
and is live in all 50 states.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191217005233/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com U.S. media Tom Donovan +1 857 559
3397 tom@tenbridgecommunications.com Ro Meghan Pianta +1 203
556 5970 meghan@ro.co
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