Elcelyx Therapeutics announced that it has formed NaZura BioHealth, a separate company established to focus on the 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 CEO of both NaZura BioHealth and Elcelyx Therapeutics. “NaZura BioHealth will commercialize Lovidia, a one-of-a-kind weight management 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, is being developed with the level of rigor typical of pharmaceutical products. It is a proprietary mix of dietary ingredients designated by the U.S. Food and Drug Administration as generally recognized as safe and FDA-approved food additives. An optimized version of Lovidia is now being readied for market. 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.
NaZura BioHealth and Elcelyx Therapeutics share the same board of directors, including Ralph Christoffersen, Ph.D., Morgenthaler Ventures (chairman); Alain D. Baron, M.D.; Rick Barry, GSM Fund LLC; Brook Byers, Kleiner Perkins Caufield & Byers; Jim Glasheen, Ph.D., Technology Partners; Ginger L. Graham, former president and CEO, Amylin Pharmaceuticals.