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Gelesis announces partnership with Ro on commercial launch of 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 BMI25–40, when used in conjunction with diet and exercise

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 US telehealth provider, will partner to offer high-quality remote care dedicated to weight management and prescription fulfilment of 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 BMI25–40, 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.

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 in the US.

Ro currently powers digital health clinics that provide a personalised 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.

“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 Dr Caroline Apovian, 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 first hand,” 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 unrivalled care on one seamless platform. Together, we can have a profound impact on how patients and physicians tackle this serious and pervasive health challenge.”

Gelesis retains worldwide sales and marketing rights for Plenity and, since FDA clearance, has secured close to US$100 million in new capital to support the US commercial launch. Gelesis initiated an early experience programme as part of its targeted US launch of Plenity in 2019 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.

“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, 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.”

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