- Biotech company Gelesis, which makes an oral hydrogel capsule to treat obesity that received FDA De Novo clearance in April, announced Tuesday it will partner with telehealth provider Ro to support the U.S. launch of the weight loss aid.
- The partnership will offer patients access through Ro's telehealth platform to physicians trained in weight management as a complement to traditional interaction with healthcare providers, Gelesis said in a press release.
- The company expects to make a limited supply of the obesity treatment available through healthcare providers and Ro's digital health clinics in the second half of 2020.
Made from modified cellulose and citric acid, the treatment, called Plenity, is authorized as a weight management aid in conjunction with diet and exercise for overweight and obese adults with a body mass index of 25 to 40 kg/m2. The capsule is taken with water before lunch and dinner, forming thousands of small gel particles in the stomach to create a feeling of fullness. The hydrogel breaks down and is eliminated through the body's natural digestive processes.
The company's pivotal trial of 436 adults showed a positive response in six out of 10 patients, who lost an average of 10% of their weight (22 pounds) and almost four inches from their waists within six months while using the treatment.
Gelesis began a targeted launch of Plenity earlier this year in the U.S. and has been expanding its commercial manufacturing capabilities to meet demand. The company recently raised nearly $100 million in new capital to support the rollout, including a funding round totaling $63.4 million led by Vitruvian Partners and a grant of $12.9 (€11.7) million from the European Regional Development Fund.
Through the telehealth partnership with Ro, Plenity will be made available to patients who don't have an established healthcare provider or would rather interact remotely with a clinician. Patients who get a prescription through the platform receive unlimited follow-up communication with their physician as well as educational resources and lifestyle recommendations.
The service can update an in-person provider on the patient's treatment plan to coordinate care. Patients who are determined to need follow-up care in person or another course of treatment will be directed to their primary care provider or a specialist, Gelesis said.
The Plenity capsule is considered a medical device because it works through mechanical modes of action. Gelesis is developing a second investigational candidate, Gelesis200, a hydrogel for weight loss and glycemic control in patients with Type 2 diabetes and prediabetes. The technology is also being studied in other GI inflammatory conditions such as non-alcoholic steatohepatitis and chronic idiopathic constipation.
The Ro platform also offers treatments for sexual health, smoking cessation and insomnia.