Tricking your body into feeling full: US FDA green lights cellulose based weight loss aid

01 May 2019 --- Biotechnology company Gelesis’ weight management prescription drug, Plenity, has been cleared by the US Food and Drug Administration (FDA) for use in obese adults, when taken in conjunction with an appropriate diet and exercise. The company is now seeking EU marketing clearance and is in discussions with global and regional strategic partners to enable a successful international launch, a company spokesperson tells NutritionInsight.

More than half of the 150 million obese and overweight adults in the US lack access to a clinically validated and FDA-regulated prescription option for weight loss, the company notes. Gelesis touts Plenity as being a safe and novel option to manage obesity without surgery or stimulants and highlights that the drug has been studied across five clinical studies throughout the US, Canada and Europe.

Some market-available prescription medications to treat obesity in the US can come with serious side effects, the Gelesis spokesperson notes. As such, these options are often only reserved for patients who have the highest BMIs or those with serious, weight-related comorbidities. As a result, across the US, only 2 percent of people with overweight or obesity are treated with prescription medications. Plenity, however, could be “a safe, groundbreaking option for the tens of millions of people with overweight and obesity.”

More than half of the 150 million obese and overweight adults in the US lack access to a clinically validated and FDA-regulated prescription option for weight loss.Plenity is administered in the form of capsules taken with water before lunch and dinner. It is made by cross-linking two naturally-derived building blocks – cellulose and citric acid – to create a three-dimensional hydrogel matrix. The capsules release thousands of “non-aggregating” particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity (firmness) of plant-based foods, such as vegetables, without caloric value. 

The gel pieces increase in volume and elasticity in the stomach and small intestine, contributing to a feeling of fullness and inducing weight loss.

“Given the complexity of the disease of obesity and the need for expanded treatment options, the Obesity Action Coalition is encouraged to see continued innovation in safe and effective chronic weight management options. We welcome Plenity’s addition as a treatment option for people affected by obesity,” says Joe Nadglowski, President and CEO of the Obesity Action Coalition. 

Historically, many weight loss agents have had adverse cardiovascular effects, leading to dangerous conditions such as strokes, heart attacks, pulmonary hypertension and valvular heart disease. This has resulted in many products being withdrawn from the market. 

Innovation is ongoing in this space, however. Last year, lorcaserin, manufactured by Eisai, was hailed a potential “holy grail” for weight loss, as a clinical trial found that it reduced weight in subjects without increasing the risk of serious heart problems.

In December, Eisai granted Brazilian pharmaceutical company Eurofarma the exclusive marketing and development rights for lorcaserin in Brazil. 

A plant-derived substance – celastrol – widely used in traditional Chinese medicine has also demonstrated promising weight loss effects in a study published in Diabetes. If celastrol also proves effective in clinical trials, it could offer a new option for the treatment of obesity, the researchers say. 

Market research conducted by Gelesis has found that overweight consumers would like access to a FDA-regulated option to aid weight management. People with overweight and obesity often feel that their only options are rooted in deprivation, which can hinder progress, the spokesperson notes.

Gelesis is currently conducting further studies with its hydrogel to learn more about its properties and potential for weight loss treatment. The company recently presented a prototype of its GS300 hydrogel products, showing how they can prevent the harmful effects of a high-fat diet on the liver in mouse models, as well as preclinical data that shows that hydrogel may restore gut barrier function after damage. 

Additionally, they are conducting an ongoing clinical study of Gelesis200, which is optimized for glycemic control and weight loss in people with Type 2 diabetes, with results anticipated in 2020. 

By Laxmi Haigh