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Flexion's FX006 delivers long-term steroids in knee joint

Sustained-release formulation cuts systemic exposure
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Flexion Therapeutics' FX006, a sustained-release formulation of the steroid triamcinolone, has been able to deliver drug to the knee joint in people with osteoarthritis (OA) for 6 weeks or more.

In the Phase II trial, 24 people with OA were treated with intra-articular injections (injections into the joint) of either FX006 or immediate-release triamcinolone. The patients tolerated FX006 well, and there were still therapeutic levels of triamcinolone in the joint at 6 weeks, when levels of the immediate-release formulation were no longer detectable.

According to the company, the levels delivered by the drug should suppress synovitis (inflammation of the lining of the joint), reducing symptoms and potentially slowing disease progression. By reducing the systemic levels of the steroid, FX006 should have fewer side effects than oral or injected immediate-release formulations. Patients are likely to prefer sustained-release versions, too, if they improve pain and inflammation control, or reduce the number of injections and clinic visits that are needed

Osteoarthritis is a major problem in an aging society and will affect almost half of the U.S. population at some point in their life. The market for intra-articular injections for this disabling disorder is worth around $1.5 billion a year. FX006 is currently in a Phase IIb trial for the treatment of mild to moderate OA of the knee, with data expected in mid-2013.

Flexion was formed in 2007 by Michael Clayman and Neil Bodick from Eli Lilly's ($LLY) Chorus group. The company has financing and licensing deals with four big pharma companies, including Pfizer ($PFE), AstraZeneca ($AZN), and Merck Serono. Earlier this month, Flexion announced a $20 million Series B round of funding, and said that it is planning to take drugs further into clinical trials, rather than licensing out at the proof-of-concept stage.

- read the press release

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