|Chelsea Therapeutics' trial protocol for experimental rheumatoid arthritis drug gets FDA nod|
|By Staff and Wire Reports|
|Thursday, 26 August 2010 09:52|
As we told our readers last Friday, Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) was set to run higher in anticipation of FDA news.This morning, the company has announced that the U.S. Food and Drug Administration (FDA) has approved the trial protocol for its experimental rheumatoid arthritis drug and it plans to start patient screening for the mid-stage trial in September.
The mid-stage trial will test the safety and efficacy of the drug CH-4051, in 250 patients against methotrexate (MTX), a common chemotherapy drug that is also used to treat autoimmune disorders like rheumatoid arthritis and psoriasis.
"Although MTX is considered the standard of care in RA, both as a monotherapy and in combination with other RA treatments, the dosing and maximal therapeutic benefit of MTX is limited by well-documented tolerability issues, long-term safety concerns and variable bioavailability," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "Given that CH-4051 is metabolically stable and that all of our preclinical and clinical work suggests enhanced absorption, dramatically increased potency and improved tolerability over MTX, we believe CH-4051 will be safe and highly efficacious in a historically treatment-resistant patient population."
The stock has been climbing higher, from a fundamental standpoint, off news that the the FDA is poised to pull ProAmitine (Midodrine) from the market due to Shire (SHPGY) not conducting post-approval studies to prove that the drug has a benefit. Shire confirmed they have elected to withdraw the product effective September 30, 2010.
Shares of the company, which have risen over 26 percent in the last seven trading sessions, are rising again this morning. As more investors become aware of these developments, the trend should continue.