Emisphere Technologies' clinical study on its oral SNAC (Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate) additive, based on Emisphere's Eligen Technology, in combination with two digestive hormones, was shown to be successful in reducing food intake and increasing satiety in healthy male subjects.
Emisphere said that the two digestive hormones utilised in the study are released naturally in proportion to ingested calories and signal satiety, or fullness, to the brain.
SNAC facilitates transport of these and other hormones with low oral bioavailability across biological membranes, such as those of the gastrointestinal tract.
In a randomised double-blind, placebo-controlled 4-way crossover trial, 12 healthy male subjects were studied, who received (in random order) 2.0mg GLP-1, 1.0mg PYY3-36, or 2.0mg GLP-1, plus 1.0mg PYY3-36.
In the study, it was observed in the trial that both digestive hormones, GLP-1 and PYY3-36, were rapidly absorbed from the gut, leading to plasma concentrations several times higher than those in response to a normal meal, while GLP-1 alone, but not PYY3-36, significantly reduced total food intake.
Co-administration of both hormones, taken in combination with SNAC in a single oral dose, reduced both total food intake by 21.5%, and increased fullness at meal onset.
Emisphere President CEO Michael Novinski said that the study provides validation of Emisphere’s Eligen Technology as one that can effectively facilitate the oral administration of therapeutic hormones with otherwise low oral bioavailability, thereby potentially eliminating major bottlenecks in drug development.