Regado Biosciences, a Basking Ridge, N.J.-based private biopharmaceutical company developing antithrombotic aptamers with active control agents, has secured a landmark $51 million Series E financing.
The round was led by new investor RusnanoMedInvest, a subsidiary of the state-run Russian investment firm RUSNANO, and included participation from another new, U.S.-based investor, Baxter Ventures. Existing investors included Edmond de Rothschild Investment Partners, Domain Associates, Quaker Partners, Aurora Funds and Caxton Advantage Life Sciences Fund.
"We are proud to say this financing is among the largest private rounds to be completed in 2012," said David J. Mazzo, PhD, president and CEO of Regado. "We welcome new investors RusnanoMedInvest and Baxter Ventures as we advance REG1 into phase III development. We also thank our existing investors for their continued confidence in our execution strategy and shared enthusiasm for uncovering REG1's full potential. We believe the magnitude of this investment and our continued ability to attract new investors is a testament to the outstanding clinical results and potential game-changing therapeutic value we have demonstrated to date for REG1."
Proceeds from the financing will support Regado's REGULATE – PCI phase III clinical study of REG1. The development program for REG1 in arterial thrombosis is being developed for use in percutaneous coronary intervention (PCI) in the acute coronary syndrome (ACS) population. Regado is also pursuing an additional parallel development program for REG1 for use in open heart surgery. While the vast majority of the funding will be used for the phase III development of REG1 for PCI, some funding will be used to advance other development programs in the Regado pipeline such as REG1 for TAVI (transaortic valve implantation) and REG3 in diabetic vasculopathy.
In the completed phase IIb RADAR clinical study, REG1 demonstrated nearly complete Factor IXa inhibition with a dose of 1mg/kg of pegnivacogin and, when followed by reversal with anivamersen, resulted in dose-dependent reduction in both the rate of major bleeding events and the incidence of ischemic events when compared to patients treated with heparin. REG1's phase IIb results show trends which may indicate significant pharmacoeconomic benefits, including improved administration convenience, faster onset of action, instantaneous reversal, immediate sheath pull at the end of the PCI procedure, faster patient ambulation, reduced need for closure devices, improved facility and staff efficiency and better overall outcomes.
"The groundbreaking data from our phase IIb RADAR study strengthened our belief that REG1 is the only anticoagulant available or in development that can simultaneously decrease the incidence of ischemic and bleeding events associated with PCI in the ACS population,” said Mazzo. “Given that the phase III REGULATE-PCI program will resemble the phase IIb in subject population, endpoints, dosing and duration of follow-up, we fully expect to confirm REG1's superior profile and paradigm-changing potential pertaining to the way anticoagulation is practiced in the acute care setting."