Gelesis Reels in $22M More, Increases Clinical Trials for Gelesis100
March 26, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Boston-based Gelesis announced today that it had closed an equity financing round for $22 million.
Gelesis focuses on a pill, Gelesis100, for weight loss. The capsule contains tiny hydrogel particles that once swallowed, expand in the stomach, simulating a feeling of fullness. Taken with water, the gels absorb water and grow to about 100 times their original size. Once in the large intestine, the water is released and reabsorbed by the body.
On Jan. 9, 2015, the company began a six-month clinical trial of 168 overweight and obese patients, including patients who are type 2 diabetics and prediabetics. The study is being conducted at 10 sites in the U.S. and Europe.
“We designed the GLOW study to assess the safety and efficacy of Gelesis100 over a longer period of time on a broader patient population, including type 2 diabetics, as compared to the First Loss Of Weight (FLOW) study,” said Hassan Heshmati, chief medical officer of the company in a statement. “We are eager to further build upon the FLOW study, which resulted in statistically significant weight loss over three months in overweight and obese patients.”
The new financing round also included the conversion of about $4 million of outstanding convertible promissory notes. The proceeds will be used to fund the clinical development of Gelesis100, as well as another pipeline product, Gelesis 200. Prior to this round of funding, Gelesis had raised $42 million in five separate funding rounds since 2006.
Gelesis is bypassing the typical round of clinical trials, Phases I, II and III, and instead treating Gelesis100 as a medical device. The reasoning behind that is because two of the undisclosed ingredients are “generally recognized as safe” by the U.S. Food and Drug Administration (FDA).
On June 23, 2014, Gelesis announced the results of its proof of concept study for Gelesis100. Over 12 weeks, patients took 2.25 grams of Gelesis100 twice a day. They demonstrated statistically significant weight loss in overweight and obese patients and what was described as “particularly dramatic weight loss in prediabetics.”
The prediabetic patients lost, on average 10.9 percent of their body weight in three months. Overweight and obese patients lost, on average, 8.2 percent of their body weight in the same period.
“Gelesis100 represents an entirely new approach to treating obesity,” said Arne Astrup, lead investigator and head of The Department of Human Nutrition, Exercise and Sports at the University of Copenhagen, Denmark in a statement. “These results are exciting and show that Gelesis100 has the potential to provide a truly novel alternative for weight loss that does not involve surgery, injections, or systemically absorbed drugs.”
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