Flexion Sees A Delayed Pop On New Data Print E-mail
By Brian Wilson - Lead Contributor   
Thursday, 19 June 2014 08:10

Earlier this week, Flexion Therapeutics (FLXN) announced topline results from the Phase IIA portion of its Phase II trial for FX006 – a non-opioid steroid treatment that is designed to provide long-term pain reduction in patients with osteoarthritis of the knee (OAK.) OAK is a very common condition, and its estimated that 21 million Americans have the condition in some way.

Currently, options for OAK patients are a bit limited. Patients can opt for hyaluronic acid joint injections (which help lubricate the knee), corticosteroids, generic pain killers, or they can opt for a specialized injection therapy called Synvisc. Because it is both effective and durable (it lasts about 6 months), Synvisc has been doing relatively well. In Q1 2014, the product generated $70 M for parent company Sanofi.

FX006 is actually a sustained-release version of a corticosteroid known as triamcinolone acetonide – a powerful synthetic corticosteroid that is used against a variety of diseases and indications (especially autoimmune).

The early data show that a single injection of FX006 lasts up to 16 weeks, which is a significant improvement over the simple and fast-acting version of triamcinolone acetonide that tends to disappear within 8 weeks.

Although the company first released the top-line results on Tuesday (June 17th), it wasn’t until the company presented some more details about the data at the Wells Fargo Healthcare Conference (specifically at 3:00 on June 18th) that the market reacted to the data.

This looks exciting, but we’ll withhold any bullish opinions for now. Corticosteroid injections are not necessarily better than the hyaluronic acid injections that already dominate the market for OAK, and we believe that Sanofi’s Synvisc is still best-in-class for this disease indication.

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