ANN ARBOR, Mich. Jan. 7 Velcura Therapeutics Inc., a clinical-phase biotechnology company developing therapies for bone disease, has completed its second successful Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for its lead compound, VEL-0230. The November 2008 IND filing enables Velcura to proceed with clinical trials in patients with stable Rheumatoid Arthritis.
A small, orally available molecule, VEL-0230 functions to both restore bone health and as a powerful anti-inflammatory agent in animal models. These properties make it an ideal therapy for a broad spectrum of bone disorders. Velcura earlier completed a successful Phase Ia clinical trial of VEL-0230 in healthy individuals. Importantly, a rapid and significant reduction in bone resorption (an important component of Rheumatoid Arthritis) was observed in individuals treated with VEL-0230. "The successful completion of the FDA's evaluation validates both our pre-clinical work and the results of our first clinical trial," said Michael W. Long., Ph.D., President and Chief Executive Officer of Velcura Therapeutics. "The properties of VEL-0230 make it an ideal therapy for treating Rheumatoid Arthritis," Dr. Long added. "Our evidence to date suggests VEL-0230 will be a powerful DMARD and we plan to move it into clinical studies in RA patients as rapidly as possible."
Extensive laboratory investigations, in vivo animal models, non-clinical toxicology evaluations and studies in humans demonstrate that VEL-0230 is a well-tolerated, safe and effective molecule. Velcura is planning a second longer-term Phase Ib/II Proof-of-Concept study in Rheumatoid Arthritis patients to begin later this year after completion of the initial study in Rheumatoid Arthritis patients, Dr. Long explained.
About Velcura Therapeutics, Inc.
Velcura Therapeutics Inc. is a biotechnology company headquartered in Ann Arbor, Michigan. Velcura's research focus is to understand human bone disease and to discover novel therapeutics that restore bone health. Velcura develops highly differentiated therapies for bone disease. Velcura then uses its patented platform technologies to discover and optimize these compounds. Velcura's lead compound, VEL-0230 was identified using its platform technologies. More information is at www.velcura.com.
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Michael W. Long, Ph.D.
SOURCE Velcura Therapeutics, Inc.