A new specialty pharmaceutical company is repurposing a drug in one of the most successful classes of cardiovascular therapies as a bone-building agent for osteoporosis.
OsteoCorp Inc., of Mill Valley, Calif., seeks $4 million in first-round financing to begin Phase II studies of a new formulation of a beta blocker that appears to have anabolic qualities when given at low doses. Today, the only bone-building agent on the market is Forteo, an injectable drug sold by Eli Lilly & Co.
The lead drug is Osoprol-CR, an oral, 24-hour time-release beta blocker. Because beta blockers have been used for about 30 years for the treatment of hypertension, arrhythmias and other cardiovascular indications, OsteoCorp expects to be able to bypass Phase I trials and go directly to Phase II studies, which it hopes to launch this year, said Chief Executive Charles S. Versaggi.
Retrospective studies have shown that people who take beta blockers tend to have stronger bones and a lower risk of fractures. Beta blockers for cardiovascular indications are typically taken at doses of 80 milligrams per day or higher. But OsteoCorp expects that doses of only 15 to 20 milligrams will be sufficient to induce bone formation. That's because the drug's anabolic effects diminish at higher doses.
Because the company plans to use lower doses than those already in use for cardiovascular conditions, it expects its drugs to be safe. After completing Phase II trials in 2009, OsteoCorp intends to raise $33 million in Series B financing to conduct a Phase III study, Versaggi said.
All told, OsteoCorp intends to put its first drug on the U.S. market by 2014 for less than $40 million in venture capital. The company also is developing a transdermal version that would deliver the drug over a seven- to 14-day period.
In addition, the company intends to explore the use of its anabolic agents in cancer patients whose tumors have spread to the bone. A cancer study is planned to take place at the University of Melbourne, in Australia, Versaggi said.
OsteoCorp was formed in 2006 on the discovery that bone formation is controlled by a part of the brain that mediates flight-or-fight response. Animal studies by the company's chief scientific advisor, Gerard Karsenty, have shown that bone-forming cells, called osteoblasts, possess special surface receptors that regulate bone formation and resorption via the neurotransmitter noradrenaline. Blocking noradrenaline receptors with a beta-blocker both stimulates bone formation and inhibits bone resorption.
The company holds worldwide patent rights to intellectual property concerning the regulation of bone formation and resorption through this pathway from Baylor College of Medicine.
In the Phase II trial, OsteoCorp would look at biomarkers that would indicate that more osteoblasts are being created than osteoclasts. It would also look for direct evidence that new bone formation is taking place.
A virtual operation, Versaggi is OsteoCorp's only employee. The company probably won't need more than a dozen or so to take its first drug to market, he said. Versaggi, who studied the bone structure and function of marine mammals to earn a doctoral degree from University of California, Santa Cruz, is also president of a corporate marketing consulting firm, Versaggi Biocommunications.
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