September 25, 2014
By Mark Terry, BioSpace.com Breaking News Staff
As a result of the early closing of a clinical trial, Basking Ridge, NJ-based Regado Biosciences, Inc. announced today it will cut 60 percent of its employees, about 20 people. In August the company announced the permanent termination of enrollment in its Phase 3 trial for Revolixys, dubbed the REGULATE-PCI trial. Originally intended to included 13,200 patients, the trial was shuttered after analysis of data acquired from the first 3,250 patients indicated serious allergic reactions.
“The DSMB (Data and Safety Monitoring Board) 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 company CEO David Mazzo in a press release. “We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete.”
With the workforce cuts, Regado believes restructuring changes and termination expenses in Q3 and Q4 of 2014 will cost about $2 million. The company expects a cash balance of approximately $61 million by the end of Q3.
“The termination of REGULATE-PCI led us to important business decisions,” Mazzo said in a press release. “The workforce reduction was a necessary action to conserve working capital and provide maximum flexibility in determining the future direction of Regado.”
The company indicates it will now focus on the final closure of the REGULATE-PCI trial and analysis, full exploration of possible business alternatives, and compliance activities required by the SEC.
Revolixys Kit is a two-component system of pegnivacogin, an anticoagulant that targets coagulation Factor IXa, and anivamersen, the complementary oligonucleotide active control agent. The clinical trial in collaboration with The Cleveland Clinic, Duke Clinical Research Institute, Canadian VIGOUR Centre, Mount Sinai School of Medicine and Parexel was designed to study the efficacy of the drug compared to bivalirudin in preventing periprocedural ischemic complications and major bleeding in patients undergoing percutaneous coronary intervention (PCI) as a treatment for coronary artery disease (CAD).
Founded in 2003, Regado Biosciences focuses on new products for antithrombotic indications in the acute care and sub-acute care setting. The company’s clinical programs concentrate on injectable anticoagulants. It has numerous patents and/or worldwide rights to its products, which include the anticoagulant systems REG1 and REG2. It also had a pipeline product, REG3, which is an inhibitor of GPVI, a platelet-specific major collagen receptor that has been implicated in a number of disorders, including ACS, rheumatoid arthritis and diabetic vasculopathy.
