PureTech subsidiary Gelesis is moving closer to filing for regulatory approval of its obesity treatment Gelesis100 after results of its latest study, it said on Monday.
Gelesis100 achieved meaningful weight loss of 5 percent or more in 58 percent of adults in the study, meeting one of two clinical targets, with almost twice as many adults losing 10 percent or more of their body weight compared with those taking a placebo.
It noted, however, that the study did not meet the other target of a 3 percent average difference from the placebo.
“Given the demonstrated weight loss and safety profile, Gelesis plans to discuss filing with regulatory authorities and, if they are supportive, plans to file for approval,” it said.
Gelesis100 is a capsule that contains small hydrogel particles that hydrate to almost 100 times their original size in the stomach.
The particles are made from two naturally derived ingredients and mix homogeneously with food in the body to reduce hunger, leading to weight loss. Once in the large intestine, the particles release most of the water, which is reabsorbed.
Analysts at broker Liberum said this is not the perfect result for PureTech, given one of the two primaries was missed.
“However, the proportion of patients losing 5 percent of body weight was almost twice the target, and the safety profile looks so clean from the top-line data that this would appear to deliver meaningful risk/benefit,” they said.
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