26th Apr 2016 09:37
LONDON (Alliance News) - PureTech Health PLC said Tuesday its Gelesis business has enrolled its first US patient in the study into its Gelesis100 oral capsulated device, after having been granted permission by the US Food and Drug Administration in July to expand the study into the country.
Gelesis is a biotechnology company focused on the development of products to safely induce weight-loss in adults who or overweight or obese. Gelesis initiated its study into its Gelesis100 oral capsulated device in November 2014 and has, since, undertaken nine clinical trials across four European countries where 125 patients have completed treatment.
On Tuesday, it announced it had its first patient from the US enrolled on the study and will now commence a six-month study into the Gelesis100 treatment across a broader patient population, taking place in 32 sites in the US, Canada and Europe. Gelesis also announced that its composition of matter patent was granted by the US Patent and Trademark office for Gelesis' technology to 2032.
This comes after Gelesis received positive confirmation from the US Food and Drug Administration in July, 2015 that the study received a Non-Significant Risk medical device study designation, which allowed it to expand the study to the US.
The Gelesis100 capsule contains small hydrogen particles which, when taken with water ahead of a meal, are designed to induce weight loss and improve glycaemic control through employing multiple mechanisms of action along the gastrointenstinal tract.
"We are excited to advance the global study of our proprietary technology, which we hope will help address the growing obesity epidemic," said PureTech Executive Vice President of Science and Technology Eric Elenko.
"We have engaged many of the top US obesity experts as investigators in this study to examine the full potential of Gelesis100 in adults who are overweight or have obesity, including those with prediabetes and type 2 diabetes, and we look forward to potentially bringing a safe and effective treatment option to those who will benefit from it most," Elenko added.
Shares in PureTech were up 0.1% at 136.18 pence on Tuesday.
By Hannah Boland; [email protected]; @Hannaheboland
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