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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