Founded in 2010, privately held Elcelyx Therapeutics is led by a management team with 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.
Can you provide a brief overview of your products and the purpose/functionality?
Alain Baron: Elcelyx’ lead product is Lovidia, composed of a proprietary mix of potent non-nutritive sweet, bitter and umami dietary ingredients that have been designated by FDA as generally recognised as safe (GRAS).
For individuals looking to manage their weight, Lovidia stimulates sensory receptors in the gut in order to magnify a cascade of hormones that trigger the onset of the sense of fullness. In effect, Lovidia stimulates sensory receptors to react as though a much greater caloric load had been consumed.
Lovidia is being developed to help [dieters and people with pre-diabetes] feel satisfied with fewer calories, avoid snacking, control their appetite and lose weight.
Lovidia has multiple commercial applications as a food additive for satiety and lower glycemic index and as an over-the-counter dietary supplement for weight loss and pre-diabetes. Examples of applications include incorporating Lovidia into processed foods such as yogurt, nutrition bars, beverages or cereal to improve glycemic index.
Lovidia’s active ingredients have been safely used by consumers for decades and therefore it has an excellent safety profile. This proprietary product is backed by rigorous science and clinical data demonstrating its ability to reduce weight with a side-effect profile no different than placebo.
Elcelyx Therapeutics is currently optimising Lovidia and it’s expected to be ready for commercialisation in 2013. Sales of Lovidia through the consumer channel could potentially exceed $1bn, according to Elcelyx’ market research.
Your products are based on the idea of ‘satiety’. Can you explain more about this concept and its association with weight management?
Baron: Satiety is the state of being satisfied, as in the feeling of fullness after eating. The biology underlying food intake and, in particular, meal cessation involves a number of hormonal and neural signals emanating from the gut which, in turn, communicate to the brain a sense of fullness and signal us to stop eating.
Diabetes and obesity are associated with a weakened satiety-signalling pathway. Therefore, approaches that strengthen or restore normal physiology are highly desirable.
Is the product on the shelf to purchase now? If not, what trials or regulatory reviews does the range of products require in order to be available on-shelf?
Baron: Lovidia is undergoing optimisation and additional rigorous clinical trials. A 400-subject efficacy trial is scheduled to begin in the first quarter of 2013.
An early version of Lovidia demonstrated statistically significant progressive and sustained weight loss in a randomised, controlled, double-blind clinical trial, with a threefold higher proportion of subjects losing 3-5% of their body weight compared to placebo over a 16-week period. The trial participants did not alter their diet or exercise.
The tolerability and safety profile of this early version of Lovidia was no different than placebo. Lovidia increases 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.
Product commercialisation is targeted for 2013. Lovidia is comprised of GRAS-designated ingredients and will not require regulatory approval as either a food additive or dietary supplement. Elcelyx is seeking partnerships and/or licensing agreements with food and beverage companies to bring Lovidia to market.
Do you believe supplementation is a key area to focus on in terms of weight loss and weight management? If so, does this apply to the upper tier of overweight individuals (obese, morbidly obese etc)?
Baron: Elcelyx believes there is a tremendous unmet need for new, safe, convenient and well-tolerated therapies, either as over-the-counter or pharmaceutical products. Two pharmaceutical medicines were recently approved by FDA for obese patients with BMI of over 30 or 27 plus one weight-related health condition, but this leaves a void for less obese or overweight individuals. (FDA will only approve medicines for obesity as it is classified as a disease.)
Supplementation is an important opportunity to address obesity and pre-diabetes because obese and overweight individuals currently have few effective over-the-counter options: One of the leading over-the-counter products approved by FDA does have modest efficacy but has undesirable side effects that limit its use, whereas dietary supplements advertised for weight loss lack clinical data to demonstrate their efficacy.
It is critical that supplements for weight loss are science-based and supported by rigorous clinical trials that demonstrate efficacy and safety, and are used in conjunction with exercise and lifestyle changes to augment the regimen’s long-term benefits. With Lovidia, Elcelyx expects to deliver drug-like efficacy and food-like safety in a supplement form.
Rebecca Prescott is editorial assistant of FoodBev.com
© FoodBev Media Ltd 2024