PLENITY manufacturing facility will be the first factory to commercially produce medical super-absorbent hydrogels synthesized from naturally derived building blocks
Targeted U.S. launch of PLENITY expected in 2H 2019, with broader U.S. availability by prescription in 2020
BOSTON, April 25, 2019 — Gelesis, a biotechnology company at the forefront of developing mechanobiology-based therapies to treat chronic diseases related to the gastrointestinal (GI) system, today announced it has received a non-dilutive $10.6 (€9.4) million grant to support the commercial manufacturing facility of PLENITY™, the company’s first commercial product, which was recently cleared by the FDA as an aid for weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m2, when used in conjunction with diet and exercise.
“Gelesis is moving rapidly to build out its supporting infrastructure for the launch of PLENITY as a prescription therapy, and this support from the Puglia Region and the European Community is a welcome non-dilutive addition to our preparations,” said David Pass, chief operating officer and head of commercial of Gelesis. “We are excited to build the first commercial manufacturing facility in the world capable of producing super absorbent hydrogels synthesized from naturally derived building blocks, based on the Gelesis core proprietary technology. This achievement is the result of many years of dedicated effort by our multi-disciplinary engineering teams. We will continue to invest in our manufacturing processes and capacity to meet demand for both commercial and clinical supply across our portfolio of hydrogel therapies in development for chronic disease.”
Gelesis’ proprietary hydrogels are orally administered and synthesized from two naturally derived building blocks – modified cellulose cross-linked with citric acid – that create a three-dimensional matrix to achieve specific mechanical properties through the GI system.
The grant was provided by the Puglia Region, where Gelesis’ current material science research & development and clinical supply manufacturing is located. The grant is intended to support the development of a new commercial-scale manufacturing facility in the region. The grant uses funds provided by the European Community via the Operative Program of the European Fund for Regional Development (FESR), which supports small enterprises with research and industrialization-integrated activity. This award marks the second grant awarded from the Puglia region of Italy. In 2011, Gelesis was awarded a $1 million grant to scale up its laboratory and manufacturing facility near the town of Lecce in Italy. Gelesis expects significant growth of its headcount as it continues its preparations for a targeted U.S. launch in the second half of 2019, before broader U.S. availability by prescription in 2020.
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 mass 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 expelled in the feces. 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.
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 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 is preparing to initiate a targeted U.S. launch of PLENITY in the second half of 2019 and anticipates PLENITY will be broadly available by prescription in the U.S. in 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 through a pipeline in other GI inflammatory conditions where gut barrier and gut permeability potentially play a role, such as non- alcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD).
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 biopharmaceutical company focused on the Brain-Immune-Gut (BIG) axis. For more information, visit gelesis.com or connect with us on Twitter @GelesisInc.
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