Amgen Drug Trial Shows Promise
Amgen Inc. said Friday that one of its experimental drugs showed promise in early-stage trials as a treatment for the bone-thinning disease osteoporosis.
That conclusion was reached by researchers who conducted a safety trial of Amgen’s osteoprotegerin, or OPG. The compound is a synthetically reproduced version of a naturally occurring protein that Amgen discovered and that it believes helps regulate bone density.’
Shares in the Thousand Oaks-based company jumped $5.19, or 24%, to close at $86.69 on Nasdaq.
The study of 52 post-menopausal women found signs that a single high-dose injection of OPG suppressed bone loss for at least 28 days.
“These results are encouraging. They confirm that the protein is actually active in humans,” said Colin Dunstan, a scientist who is heading development of OPG for Amgen.
“Based on this study, it looks like OPG is going to work,” said B. Lawrence Riggs, an endocrinologist with the Mayo Clinic who reviewed a summary of the data.
The discovery of OPG may be one of the biggest developments in the field of bone research in the last decade, Riggs said.
The trial is the first of two safety studies Amgen will complete before deciding whether to proceed with development of the drug.
Once safety trials are complete, Amgen will decide whether to begin the second of three stages of human trials that the Food and Drug Administration requires before it will consider a new drug for approval.
‘It’s still [the] early days,” Dunstan said. “It’s a long path to get something through the clinical trial stage.”
The results were presented in St. Louis at a meeting of the American Society for Bone and Mineral Research, one of the world’s largest annual gatherings of bone specialists.