Elcelyx Therapeutics is developing ultra-safe products for weight management and obesity-related metabolic disorders based on the science of nutrient sensing.
The Elcelyx Gut Sensory Modulation (GSM) platform has produced two product candidates—Lovidia™ for use in nutritional supplement, food and beverage applications, and NewMet™, a pharmaceutical for patients with type 2 diabetes. Both are composed of active dietary or pharmaceutical ingredients that have been safely used by consumers for decades. These products, alone or in combination, have the potential to safely address the tremendous unmet medical needs in diabetes and obesity.
Founded in 2010, Elcelyx is led by a management team with extensive expertise in metabolic disorders, having developed the first medicines that mimic the body’s natural gut hormones to treat diabetes (BYETTA, BYDUREON and SYMLIN, Amylin Pharmaceuticals) and the role of gut hormones in controlling weight. Elcelyx is funded by top tier venture firms Morgenthaler Ventures, Kleiner Perkins Caufield & Byers and Technology Partners.
Gut sensory modulation: a new approach to obesity, diabetes
In response to nutrient ingestion, specialized cells called enteroendocrine cells located in the lining of the gut release several hormones into the circulation. These hormones include peptide YY (PYY), which signals satiety to the brain, and glucagon-like peptide-1 (GLP-1), which plays an important role in glucose regulation. Elcelyx hypothesized that the nutrient-driven release of these important hormones could be amplified by delivering potent compounds to activate chemosensory receptors located on these cells. Elcelyx has named this proprietary approach Gut Sensory Modulation (GSM).
Importantly, because these gut sensory modulators work primarily in the lower gut, there is minimal absorption into the bloodstream. Compounds with low bioavailability provide a distinct safety advantage over conventional pharmaceutical approaches for treating metabolic disorders.
Based on its GSM platform, Elcelyx is developing over-the-counter and FDA-regulated products utilizing state-of-the-art, scientifically rigorous pharmaceutical drug development methods.
Elcelyx’ nearest-term opportunity is Lovidia, a proprietary combination of GRAS (Generally Recognized As Safe) dietary ingredients, targeted to the consumer market. The potent non-nutritive sweet, bitter and umami GRAS-designated compounds are delivered to the lower gut where they activate chemosensory receptors on EECs, in effect stimulating the cells to react as though a much greater caloric load had been consumed. Lovidia can be used for multiple applications including as a dietary supplement for weight loss and prediabetes and as a food and beverage additive for appetite control and lower glycemic index.
Elcelyx has completed multiple randomized, placebo-controlled, double-blinded, cross-over clinical studies to demonstrate that a prototype of Lovidia taken before meals activated EECs and enhanced secretion of both PYY and GLP-1 relative to placebo.
To determine the prototype’s effects on weight loss, Elcelyx conducted a randomized, placebo-controlled, double-blinded trial designed to assess the effect on weight loss in overweight and obese subjects. In a 16-week study evaluating 121 obese subjects who were not directed to alter their diet or exercise, the prototype demonstrated statistically significant progressive and sustained weight loss, with a threefold higher proportion of subjects losing three to five percent of their body weight compared to placebo. The prototype was also shown to increase the body’s production of natural satiety and gluco-regulatory gut hormones twofold; with the same number of calories, subjects had twice the satiety signal. The prototype’s tolerability and safety profile was similar to placebo.