Concert Pharmaceuticals Enters Clinical Trials with Drug for Hot Flashes

Xconomy Boston — 

Concert Pharmaceuticals is moving ahead with a drug that it hopes will be the first of its kind to treat the hot flashes women get during menopause, without exposing them to the well-documented risks of hormone-replacement therapy.

The Lexington, MA-based company said today it has begun its first clinical trial with a drug candidate called CTP-347. The company combined the news with another announcement that clearly gave it confidence to move ahead: Animal tests reveal its drug can avoid bad drug-drug interactions with tamoxifen, a common breast cancer drug, according to research presented at the North American Menopause Society’s meeting in Orlando.

As we reported back in May, the drug is made by replacing a few hydrogen atoms on a drug called paroxetine with deuterium atoms. That chemical trick allows Concert to retain the action of paroxetine against hot flashes, while minimizing its ability to block a critical liver enzyme for drug metabolism, CYP2D6. Since tamoxifen—a drug taken by millions of menopausal women to combat breast cancer risk—is metabolized by that enzyme, interfering with it could cause problems. Basically, if you gave it in combination with paroxetine, it could cause a big-time traffic jam at that enzyme, causing the drugs to build up in the body and cause side effects.

“We believe our deuterium chemistry platform holds great promise in creating novel compounds with superior safety and efficacy as compared to existing therapies,” said Roger Tung, Concert’s CEO, in a statement.

Concert raised $37 million from a syndicate of investors in May, including new investors Adage Capital Management, SR One, Mediphase Venture Partners, and Westfield Capital Management, as well as existing investors including Three Arch Partners, TVM Capital, Skyline Ventures, Brookside Capital Partners Fund, Flagship Ventures, Greylock Partners, New Leaf Venture Partners, and QVT Fund.

Results from the Phase I clinical trial in hot flashes are expected in the first half of 2009, so those investors will start to get a read on whether the new drug has an ability to avoid toxic drug-drug interactions in people as well as animals. Since this candidate took less than two years to bring to clinical trials, if it demonstrates safety in Phase I, other modified drugs with deuterium may not be far behind.