VEL-0230: Velcura Therapeutics to initiate rheumatoid arthritis trials

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Velcura Therapeutics to initiate rheumatoid arthritis trials

www.pharmaceutical-business-review.com/article_news.asp?guid=17835702-AF43-4CAA-\

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8th January 2009

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.

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.

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. "