8/25/2014 6:04:48 AM
Regado Biosciences, Inc. Permanently Halts Enrollment In Lead Drug Trial
August 25, 2014
By Krystle Vermes , BioSpace.com Breaking News Staff
New Jersey-based Regado Biosciences, Inc. (RGDO) announced today that it will cease enrollment in its REGULATE-PCI Phase 3 trial for its lead program, Revolixys Kit. This news comes after the Data and Safety Monitoring Board made suggestions toward this move.
The Data and Safety Monitoring Board analyzed data from about 3,250 patients who had enrolled in what was supposed to be a 13,200-patient trial. The goal of the study was to compare the safety and efficacy of Revolixys Kit with bivalirudin.
"The DSMB indicated that the level of serious allergic adverse events associated with Revolixys was of a frequency and severity such that they recommended that we do not enroll any further patients in the REGULATE-PCI trial," said David J. Mazzo, Ph.D., CEO of Regado. He continued, "We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete."
Regado Biosciences focuses on the discovery and development of novel, oligonucleotide-based actively controllable therapeutics. Revolixys Kit is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. This is currently Regado’s leading product candidate.
The Potential of REG2
While the ending of this Phase 3 trial is a not a positive development for Regado, the company has seen success in other areas of testing. In June, Regado had data published in the Journal of Thrombosis and Thrombolysis that showed how REG2 impacted patients in a Phase 1 clinical trial.
REG2 is a clinical-stage product candidate that includes a subcutaneous depot formulation of pegnivacogin, combined with an intravenous injection of anivamersen. Pegnivacogin and anivamersen are also included in Revolixys Kit.
The data published in the Journal of Thrombosis and Thrombolysis demonstrated the dose and concentration-dependent attenuation of thrombin generation and subsequent restoration of thrombin following the reversal linked to REG2. To compile the data, 32 volunteers took part in the study.
"These results support the choice of FIXa as an excellent target for anticoagulant therapy,” said Christopher Rusconi, Ph.D., Regado's Chief Scientific Officer and co-discoverer of the Regado controllable aptamer technology.
Regado is developing REG2 for a variety of acute and sub-acute care cardiovascular indications. The goal is to make REG2 an option for patients who are unable to take oral anticoagulants for a period of time before or after surgery.
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