Regado takes a beating as big PhIII study faces safety review

Shares of Regado Biosciences took a nasty beating Thursday evening after the company put out the word that enrollment in its big, self-funded Phase III study of a new anticoagulant had to be put on hold so that a safety monitoring committee could check out "serious adverse events related to allergic reactions."

That's not what investors want to hear after helping support the company into a $150 million study. Shares had dropped by half as of this morning, with the stock down to $3.31--even below its beaten-down offering price for one of 2013's least successful IPOs.  

Basking Ridge, NJ-based Regado took some big risks when it decided to go it alone in Phase III with REG1, an experimental anticoagulant designed to be used to control bleeding during heart surgery. The company launched the late-stage study openly acknowledging that it would need to raise more cash than its venture backers had been willing to put up in its latest round, Some analysts took that as a bad sign, particularly as no Big Pharma partner had come along to ink a licensing deal on the drug.

CEO David Mazzo emphasized in a brief call with analysts this morning that the safety review dealt with "potential" allergic reactions.

"This process takes several weeks at a minimum" due to the international mix of trial sites used in the study, Mazzo said, estimating that it will be another 8 weeks before they learn more about the safety profile to be seen among the 3,234 patients already enrolled in the study. The CEO was entertaining no questions this morning and offered little new information.

Regado is betting the farm on REG1, which uses two agents--pegnivacogin and anivamersen--to control bleeding during a coronary intervention and open heart surgery. Regado aims to prove that the combo can give physicians a tool to manage coagulation, 'dialing' the anticoagulation effect up or down to enable doctors to safely hit a maximum dose for each patient. Pegnivacogin is a Factor IXa inhibitor which can be reversed partially or completely by anivamersen. Faster, safer surgical interventions for this growing patient population come with the promise of some immediate health benefits as well as the prospect of a reduced number of adverse incidents along with lower hospitalization costs.

"Drug development by its nature is a gamble, a calculated gamble," Mazzo told FierceBiotech after the company stumbled out of the IPO gate last fall.

As of this morning, the bets are once again going against the company. 

- here's the release