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news.Velcura Therapeutics, a biotechnology company, has completed its second successful investigational new drug application to the FDA for its lead compound, VEL-0230. The November 2008 investigational new drug application filing enables Velcura to proceed with clinical trials in patients with stable rheumatoid arthritis.
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Velcura earlier completed a successful Phase Ia clinical trial of VEL-0230 in healthy individuals. Importantly, a rapid and significant reduction in bone resorption was observed in individuals treated with VEL-0230.
According to the company, VEL-0230, a small, orally available molecule, functions to both restore bone health and as a powerful anti-inflammatory agent in animal models.
Velcura is planning a second longer-term Phase Ib/II proof-of-concept study in rheumatoid arthritis patients to begin in later 2009 after completion of the initial study in rheumatoid arthritis patients.
Michael Long, president and CEO of Velcura, said: “The successful completion of the FDA’s evaluation validates both our preclinical work and the results of our first clinical trial. The properties of VEL-0230 make it an ideal therapy for treating rheumatoid arthritis.”