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SOURCE Regado Biosciences, Inc.
Phase 1 Clinical Data Highlights Factor IXa as an Excellent Target for Anticoagulation Therapy
BASKING RIDGE, N.J., June 23, 2014 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the discovery and development of actively controllable aptamer therapeutics for the acute care setting, today announced the publication in the Journal of Thrombosis and Thrombolysis of data from a single escalating-dose Phase 1 clinical trial of the REG2 anticoagulation system. The published data demonstrates the dose and concentration-dependent attenuation of thrombin generation and subsequent restoration of thrombin following reversal associated with REG2.
REG2 is a two-component system consisting of a subcutaneous depot formulation of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary intravenous injectable oligonucleotide active control agent, anivamersen. REG2 is being developed to be the preferred therapeutic option in high value sub-acute venous thrombosis indications such as DVT and VTE prophylaxis. REG2 will be an important part of the life cycle franchise strategy associated with Revolixys™ Kit which ultimately entails broad use throughout the hospital.
Christopher Rusconi, Ph.D., Regado's Chief Scientific Officer and co-discoverer of the Regado controllable aptamer technology, commented, "These results support the choice of FIXa as an excellent target for anticoagulant therapy. In addition, the concentration-dependent inhibition of thrombin generation observed in this study further supports the pegnivacogin dose selected for the REGULATE-PCI Phase 3 study of the companion product candidate, Revolixys™ Kit."
The study included 32 healthy volunteers who were enrolled sequentially into four cohorts. Patients in cohorts 1-3 were randomized (3:1) to ascending doses of pegnivacogin, from 0.5 mg/kg to 3 mg/kg, and placebo, with no anivamersen administered. In cohort 4, all patients received 2 mg/kg open-label pegnivacogin and were randomized (1:1) to reversal by one dose or multiple doses over time of 1 mg/kg anivamersen. Parameters of the CAT assay included time to peak thrombin generation (PTm), endogenous thrombin potential, peak thrombin generation and velocity index (VIx).
REG2 is a clinical-stage product candidate comprising a subcutaneous depot formulation of pegnivacogin paired with an intravenous injection of anivamersen, the specific complementary control agent to pegnivacogin. Pegnivacogin and anivamersen are the same active moieties found in Regado's lead clinical program, Revolixys™ Kit. REG2 is formulated to provide a controllable level of anticoagulation for up to two weeks for sub-acute uses, especially in cases where a patient may be unable to swallow an oral anticoagulant. Regado is developing REG2 for potential uses in a variety of acute and sub-acute care cardiovascular indications such as venous thromboembolism prophylaxis in patients undergoing abdominal surgery, as treatment for transcatheter aortic valve implantation (TAVI) patients and for bridging patients who are unable to take oral anticoagulants for a period of time before or after a surgical procedure.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a biopharmaceutical company focused on the discovery and development of novel, oligonucleotide-based actively controllable therapeutics. Our initial focus is on applications in the acute and sub-acute cardiovascular therapeutic area. The company's lead product candidate, Revolixys™ Kit, is a two-component system consisting of pegnivacogin, an injectable anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary injectable oligonucleotide active control agent, anivamersen. Revolixys Kit is currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 trial enrolling 13,200 patients with coronary artery disease (excluding those with ST-elevated myocardial infarction) undergoing percutaneous coronary intervention (PCI), a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. Regado's actively controllable product candidates have the potential to improve patient outcomes and enhance the patient experience, provide direct therapeutic control to physicians and reduce overall treatment costs. More information can be found at www.regadobio.com.
For more information on REGULATE-PCI, please visit:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the progress of REG2's phase 1 clinical trial or the REGULATE-PCI trial, enrollment in REG2's phase 1 clinical trial or the REGULATE-PCI trial and the prospects for the completion of REG2's phase 1 clinical trial or the REGULATE-PCI trial and any regulatory approval of REG2 or Revolixys Kit and the successful commercialization of REG 2 or Revolixys Kit if approved. The company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from those projected in forward-looking statements include the "Risk Factors" described in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to, our Annual Report on Form 10-K for the fiscal year ended December 31, 2013, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2014. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company has no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
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