Elcelyx Therapeutics has established NaZura BioHealth, a separate company focusing on development of Gut Sensory Modulators (GSM) including lead product Lovidia, a dietary supplement for weight management. Elcelyx retains pharmaceutical product candidate NewMet, the company’s proprietary delayed-release formulation of metformin for the treatment of patients with type 2 diabetes. Elcelyx has funded NaZura with a credit line of $5 million, which will be used for clinical development of Lovidia and pre-commercial activities.
“We are separating the Lovidia and NewMet assets in order to maximize their value as we approach critical development milestones,” said Alain D. Baron, M.D., president and chief executive officer of both NaZura BioHealth and Elcelyx Therapeutics. “NaZura BioHealth will commercialize Lovidia, a one-of-a-kind weight loss product with launch planned for early second quarter 2014, and Elcelyx Therapeutics will continue to advance NewMet for type 2 diabetes.”
Lovidia, a dietary supplement, demonstrated statistically significant and progressive weight loss through 16 weeks in a randomized, placebo-controlled, double-blind clinical study. In 121 evaluable overweight or obese subjects, three times as many people lost 5% of their body weight compared to placebo. This was accomplished without diet or exercise modification and the tolerability and safety profile of the prototype was similar to placebo. In other short-term studies, preliminary formulations of Lovidia increased the body’s food-driven production of natural satiety and gluco-regulatory gut hormones twofold; with the same number of calories, subjects had twice the satiety signal.
An optimized version of Lovidia is now being readied for market. It is expected this optimized product will produce greater weight loss than that seen with the prototype. A 16-week clinical study using the optimized Lovidia product is now underway. This placebo-controlled, double-blind weight loss study in 240 overweight and obese subjects is fully enrolled with results expected in the fourth quarter of 2013.
Lovidia is a proprietary mix of dietary ingredients designated by the FDA as Generally Recognized as Safe (GRAS) and FDA-approved food additives.