San Diego-based Elcelyx Therapeutics is jumping out of stealth mode today with news that it has picked up an extended venture round, bringing its total venture backing to $20 million as the fledgling biotech pursues a new formulation of metformin as well as a dietary supplement. Both of these programs are aiming at an "ultra-safe" pair of approaches for obesity and diabetes, with A-list venture backers at Morgenthaler and Kleiner Perkins Caufield & Byers fueling the work. And the developer added a business development chief to its virtual team today as well, signaling that it's serious about signing on partners in the near term.
The biotech is currently advancing NewMet, a delayed-release formulation of metformin aimed at the lower gut. By targeting the gut, the company believes it can bypass the kind of systemic exposure that can cause a buildup of metformin in the blood, forcing diabetics suffering from renal impairment off of the generic therapy. Their other program is Lovidia, which uses a dietary supplement that triggers the production of "natural satiety and gluco-regulatory gut hormones." Opposed to the same number of calories, the biotech notes, "subjects had twice the satiety signal."
Obviously the dietary supplement isn't subject to the kind of clinical trial regime required of new therapeutics, but CEO Alain Baron tells FierceBiotech this morning that he's aiming at completing a program "more drug-like in scientific rigor," with an efficacy profile that approaches a therapeutic. NewMet has completed a Phase IIa trial and is now in a IIb study. And the CEO says that company execs plan to meet with regulators early in 2013 to discuss a regulatory pathway toward approval.
Elcelyx, which is adding $4 million of a planned $7 million B-round extension, says it hopes to start commercializing Lovidia next year. In one study of an earlier version of Lovidia involving 121 obese patients, the proportion of subjects losing 3 to 5 percent of their body weight was threefold greater on Lovidia versus placebo.
The Elcelyx team of 7 may be small, but it's experienced. Baron is a former senior VP of research at Amylin, which produces a pair of diabetes drugs and was recently bought out by Bristol-Myers Squibb ($BMY). And the team, which now includes Mark Wiggins as head of business development, believes it can skirt the kind of safety questions that slowed Arena ($ARNA), Vivus ($VVUS) and Orexigen ($OREX). Baron says it has the potential to start marketing Lovidia on its own, but notes that a primary care drug like NewMet will definitely need a major market player to handle promotional work.
"We are very open to any number of partnerships or acquisitions," says Baron. Technology Partners also contributed to the recent venture extension.
- here's the release on the venture cash
- and the release on the new hire
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