Flexion Overhaul Bears Fruit With Upbeat Data From Arthritis Trial

5/30/12Follow @arleneweintraub

[Updated 5/30/12 8:30 am. See below.] Today Woburn, MA-based Flexion Therapeutics announced that its treatment for osteoarthritis met its goal of significantly relieving joint pain in a mid-stage trial. Even though it’s a bit early to declare the drug a success, the results come as welcome news to the executives of Flexion, who have spent much of the last year completely revising their original business plan. “It’s gratifying to see this data,” says Flexion’s CEO Michael Clayman. “It gives us confidence in the rest of our portfolio.”

Flexion was founded in 2007 with a plan to take drugs that had been shelved by Big Pharma companies, and then run them through efficiently designed trials to quickly determine whether they should be developed to treat inflammatory diseases. The company raised $42 million from an impressive list of backers, including Pfizer (NYSE: PFE), AstraZeneca (NYSE: AZN), and Merck KGaA, which all wanted to test Flexion’s idea.

But Clayman and his co-founders quickly recognized a problem: Big Pharma deals were increasingly becoming less lucrative. “They were doing a lot of option-based deals with relatively modest up-front payments,” Clayman says. “We became concerned about the ability to adequately monetize our assets.”

At the same time, one of the drug candidates Flexion had acquired—a molecule called FX005, which came from AstraZeneca—was looking increasingly attractive. FX005 is injected straight into arthritic joints, and it works by inhibiting an inflammatory protein called p38 MAP kinase. The company believes that the data it announced today represent the first-ever proof that inhibiting this protein provides an effective therapy in osteoarthritis. During the 12-week trial, FX005 was proven to improve joint pain and function after the first month, when compared to placebo. Flexion hopes to present more details about the study at a medical conference later this year, Clayman says.

The main ingredient in FX005 is contained in “microspheres,” which slowly release the drug over a period of months. Clayman says that in early trials, the drug mostly stayed in the joint, which reduced the chances of it producing unwanted side effects. The drug is being tested in patients with knee pain.

FX005 is the lead drug candidate in a portfolio that is entirely focused on treatments for osteoarthritis. Flexion is also working on FX006, a long-lasting corticosteroid injection to suppress … Next Page »

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