Looking to wrap up its package of data to present to the FDA on its anal pain drug VEN 307, Ventrus Biosciences instead wound up with a failed Phase III study as a high placebo response wiped out the efficacy advantage that they were expecting. Investors took the news as a nasty surprise, submitting the biotech's shares to a drubbing as its stock price collapsed, dropping 63%.
New York-based Ventrus ($VTUS) had expected to see a repeat of the better data gathered in the first late-stage study of VEN 307 (diltiazem 2% cream). Investigators recruited 434 patients for this latest effort, which the biotech said was primarily mounted to demonstrate clear safety signals, which the company says it got.
Ventrus has had its ups and downs over recent years. In 2012 it was forced to dump a program--VEN 309--for an experimental therapy to treat hemorrhoidal disease, another catalyst that triggered a share price rout.
Nevertheless, Ventrus believes it can pursue an NDA with the FDA, planning to set up a meeting with regulators to review the results. But with a market cap of only $34 million, the tiny biotech will have a tough road ahead.
"While this second study confirms a consistent effect in decreasing AF-related pain with diltiazem 2%, results among placebo patients are inconsistent across these two pivotal studies," said Dr. Russell Ellison, the CEO at Ventrus Biosciences, in a statement. "Compounded diltiazem remains an important non-nitroglycerin treatment standard in this condition, yet this is an area which we believe may be more safely and reliably served by an FDA approved prescription pharmaceutical treatment. We look forward to discussing these results with the FDA."
- here's the press release