With Kythera Biopharmaceuticals as Model, Lithera Tests Drug to Shrink "Love Handles"

At the end of last year, the venture fund established by Domain Associates and Russia’s Rusnano disclosed that they had invested $20.6 million in San Diego-based Lithera, an aesthetic biotech developing a drug to reduce the fat tissue that builds up under the skin. Now the six-year-old startup is taking the next step. In a statement today, Lithera says it has initiated a large, mid-stage trial of the drug, an injectable version of salmeterol xinafoate, a selective beta agonist developed for localized reduction of fat tissue. Salmeterol already is used as an aerosol inhalant for treating asthma (marketed as Serevent). Lithera says top line data from its 500-patient trial are expected by the end of September. In a phone call earlier today, Lithera CEO George Mahaffey says Lithera has revised its initial formulation of salmeterol to optimize its use in reducing abdominal fat tissue in normal, healthy people who are under 45 years old. Women account for about 87 percent of the potential market. The current standard of practice for such people, who find it hard to lose their “love handles” even with exercise and a healthy diet, would be liposuction, Mahaffey says. The Lithera CEO says he believes the company’s market has plenty of room to grow, because many women who are unwilling to undergo liposuction would be more willing to try an injectable drug to shrink their abdominal fat. In any case, liposuction ranks as the top cosmetic surgery in the United States, with more than 350,000 procedures done each year.