Biotechnology company Gelesis has reported positive results from a first-in-human study of Gelesis200, the company’s next-generation product designed to treat type 2 diabetes patients.
Gelesis200 is an orally administered capsule containing small hydrogel particles, which seeks to encourage weight loss and improve glycemic control in patients with type 2 diabetes.
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The study results showed that Gelesis200 was generally well-tolerated and no serious adverse events (AEs) were reported during the study, which is a single-centre, randomised, double-blind, placebo-controlled, two-cohort, four-arm, crossover study.
The total number of AEs reported in the active treatment arms was comparable to the total of AEs reported in the placebo arms.
Gelesis noted that the results also indicated that giving Gelesis200 three times in a single day did not result in more AEs than administering it two times in a single day.
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In addition, the timing of administration of Gelesis200 (ten minutes versus 30 minutes before a meal) did not affect the number of AEs.
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By GlobalDataThe majority of AEs reported in the active treatment arms were mild, of which the most common were gastrointestinal-related and headache.
The study’s primary objective was to evaluate the safety and tolerability of Gelesis200 following two or three administrations of 2.10g in a single day, before breakfast and lunch or before breakfast, lunch and dinner, in adults who are overweight or have obesity but are otherwise considered healthy.
The study enrolled 24 male subjects with body mass indexes ranging from 28 to 33.
Gelesis chief medical officer Dr Hassan Heshmati said: "Our next step will be to assess Gelesis200 in a three-month proof-of-concept study, expected to read out in the first half of 2017, with the goal of ultimately offering a novel weight management and glycemic control product for patients with type 2 diabetes."
