BOSTON--(BUSINESS WIRE)--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.
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.
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.
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.
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.