Puretech’s Gele­sis flunks the FDA’s key mea­sure of suc­cess for weight loss treat­ments

PureTech port­fo­lio com­pa­ny Gele­sis says that their weight loss treat­ment failed a key mea­sure of suc­cess in a piv­otal tri­al but plans to try to hus­tle this along for a reg­u­la­to­ry fil­ing in any case with a hit on a co-pri­ma­ry end­point mea­sur­ing how many pa­tients as a group were able to hit weight-loss goals mea­sured by in­ves­ti­ga­tors.

On the one hand, 58% of the over­weight sub­jects con­sum­ing its hy­dro­gel cap­sule treat­ment dubbed Gele­sis100 lost at least 5% of their body weight, com­pared to 42% of the place­bo group. For the 10% mark, the split was 20% to 12%. But the treat­ment failed to break a min­i­mal stan­dard of ef­fi­ca­cy, falling short of a 3% mean dif­fer­ence in weight loss with the place­bo group.

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