Emisphere Reports Positive Clinical Results for Its Oral Drug Delivery Technology

Emisphere Technologies, Inc. announced that a clinical study found that the company’s proprietary oral SNAC (Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate (“SNAC”) additive, in combination with two digestive hormones, was successful in reducing food intake and increasing satiety in healthy male subjects. The study was published in the August 18, 2010 online edition of the American Journal of Clinical Nutrition, the official publication of the American Society for Nutrition. “This study provides validation of Emisphere’s Eligen(R) 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,” noted Emisphere President and Chief Executive Officer Michael V. Novinski.

As described in the publication, 12 healthy male subjects were studied in a randomized double-blind, placebo-controlled 4-way crossover trial. Each subject received (in random order) 2.0 mg GLP-1, 1.0 mg PYY3-36, or 2.0 mg GLP-1, plus 1.0 mg PYY3-36.

Researchers observed 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. 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 percent, and increased fullness at meal onset (P <0.05). The 24-hour food intake was not affected by the single oral administration of the native hormones likely due to their short half-life. The two digestive hormones utilized in the study are released naturally in proportion to ingested calories and signal “satiety,” or fullness, to the brain. SNAC, which is based on Emisphere’s Eligen(R) Technology, facilitates transport of these and other hormones with low oral bioavailability across biological membranes, such as those of the gastrointestinal tract. Emisphere had previously announced that SNAC had achieved Generally Recognized as Safe (“GRAS”) status for its intended use in combination with nutrients added to food and dietary supplements.