Regado Biosciences, Inc., Announces FDA Acceptance of IND for REG2

Print 13 February 2014

REG2 Extends Regado's Next-Generation Anticoagulation Therapy Franchise as Phase 3 REGULATE-PCI Clinical Trial of REG1 Advances

BASKING RIDGE, N.J., Feb. 13, 2014 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced that the United States Food and Drug Administration (FDA) has accepted the company's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future.

REG2 is comprised of a subcutaneous depot formulation of Regado's aptamer-based anticoagulant pegnivacogin designed for a slower onset of activity and a durable antithrombotic effect. Like REG1, it is paired with an intravenous (I.V.) bolus formulation of anivamersen intended to be used as an active control agent, if needed.

"Our Phase 3 REGULATE-PCI trial of REG1 remains our primary focus at Regado, however the FDA's acceptance of the IND for REG2 is a significant accomplishment that extends our clinical pipeline and advances our mission of transforming the anticoagulation therapeutic market," said David J. Mazzo, Ph.D., chief executive officer of Regado Biosciences. "We believe there is significant medical need for a safe, extended-release anticoagulant for sub-acute indications, and, based on the safety and clinical results for pegnivacogin to date with REG1, we are enthusiastic about advancing REG2 further into clinical development."

ABOUT REG2
REG2 is an early clinical-stage program evaluating an extended release formulation of pegnivacogin, the same Factor IXa inhibiting anticoagulant used in REG1.  REG2 is formulated for subcutaneous depot injection and is intended 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 development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications. Regado is pioneering the development of two-component drug systems consisting of a therapeutic aptamer and its specific active control agent. The company's lead product candidate, REG1, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. REG1 is currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 study enrolling 13,200 patients with acute coronary syndromes (ACS) 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, enhance the patient experience and reduce overall treatment costs. More information can be found at www.regadobio.com.

For more information on REGULATE-PCI, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01848106  

Forward-Looking Statements
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 regarding our ability to obtain, maintain, defend and enforce intellectual property rights protecting our product candidates and the scope, coverage and enforceability of our intellectual property rights. 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 the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on Nov. 8, 2013, and in the Company's other periodic filings with the SEC.

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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