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Drug Uses Trick Play In Weight-Loss Game

Maybe it’s the beaches, bikinis and sunshine. Maybe it’s the local talent pool. Either way, with two novel diet drugs currently in the labs at the Salk Institute for Biological Studies and Neothetics Inc., it looks like San Diego County is the new hub for body-sculpting science.

After a decade of still waters in the weight-loss drug market, pills and therapies began resurfacing in 2012 when Vivus Inc. introduced Qsymia. San Diego’s Arena Pharmaceuticals Inc. quickly followed suit with Belviq, and then La Jolla-based Orexigen Therapeutics Inc. brought Contrave to the scene late last year.

Now, two additional drugs may come out of the county. This time, however, the scientists are focusing less on altering the brain and more on attacking the culprit — fat cells.

The Phantom Meal

Risk has been a special concern for weight-loss drugs since the diet drug combination of fenfluramine and phentermine, better known as fen-phen, was found to cause death and heart damage in the late 1990s. Fenfluramine was banned by the U.S. Food and Drug Administration; phentermine was allowed to stay on the market.

Now, Salk researchers have developed an entirely new type of pill called fexaramine. Dr. Ken Fujioka, a weight-management and metabolic specialist at Scripps Health, said it is safer than most diet drugs. Unlike most weight-loss pills on the market, fexaramine doesn’t dissolve into the blood like appetite suppressants or caffeine-based diet drugs. Rather, it remains in the intestines, causing fewer side effects.

“It’s what we call ‘peripheral’ and not central in its target,” Fujioka told the U-T San Diego in January. “This means we are using something outside of the brain and yet getting weight loss.”

Ronald Evans is the director of Salk’s Gene Expression Laboratory and the senior author of the study on fexaramine published this summer in the scientific journal Nature Medicine.

“This pill is like an imaginary meal,” Evans said. “It sends out the same signals that normally happen when you eat a lot of food, so the body starts clearing out space to store it. But there are no calories, and no change in appetite.”

When given to obese mice for five weeks, the mice stopped gaining weight, lost fat and had lower blood sugar and cholesterol levels than untreated mice, according to a recent Salk news release. In addition, the mice had a rise in body temperature — which signals the metabolism is ramping up — and some deposits of white fat in their bodies converted into a healthier, energy-burning brown tissue.

Fujioka said the effect of turning white fat to brown fat is of special interest, as it’s easier to lose brown fat than white.

Since fexaramine doesn’t reach the bloodstream, the researchers hypothesize that a rapid start to human clinical trials is feasible. Salk does not conduct human trials, but they do partner with a variety of research institutes and hospitals to test research. Human trials will likely not begin for at least 12 months, according to the institute.

The Contour Drug

San Diego-based Neothetics is also developing a way to shape up, but it’s not targeting obese — or even marginally overweight — patients. Instead, the company’s president and CEO George Mahaffey said the drug is intended “to make thin people thinner.”

“We don’t make big people little,” Mahaffey said, “Our patients are already in shape. This is for the person who works out and takes care of their diet but can’t get rid of the love handles or the pooch on their belly. It’s like spot dieting.”

The injectable drug, called LIPO-202, causes the body to metabolize fat around the injected area, converting it into energy. The beta-2 receptor is what the body signals when it wants fat to be burned. LIPO-202 “tickles” the receptor the same way the body does, resulting in shrinking fat cells, Mahaffey said.

If approved, patients would receive an array of microshots across the belly once a week for eight weeks. Mahaffey said patients would notice the first half of the drug’s effectiveness by week four, and the final effects by week eight.

Neothetics, previously known as Lipothera Inc., completed its initial public offering in early December, raising $60.5 million. Mahaffey said the company is using the funds to get back into the clinic and plans on having Phase 3 data by the end of 2015. The company is on track to file a new drug application with the FDA in the second half of 2016. And if all goes according to plan, LIPO-202 would be on the shelves by 2017.

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