The Medicines Company Announces Initiation of Phase II Study for its Investigational Anesthetic, ABP-700
The Medicines Company announced today that it has dosed the first patient in a Phase II study of ABP-700 in procedural sedation. The Phase II study follows within weeks of completion of Phase I clinical pharmacology, dosing and safety studies, including its use with pre- and co-medications routinely given as part of procedural sedation and induction of general anesthesia. The Phase II-III development program for ABP-700 has been named VERONA by the company.
The first Phase II study in the VERONA Program is expected to enroll 75 patients undergoing elective colonoscopies at three sites in The Netherlands. The study tests three ABP-700 infusion regimens with the goal of enabling successful procedure completion.
“The five Phase I studies we completed support our conclusions that ABP-700 has the potential of a unique profile, can be administered with routine pre-and co-medications, and is well tolerated in normal subjects,” said Jason A. Campagna MD, PhD, Senior Vice President Surgery and Peri-Operative Care and ABP-700 Program Lead. “We are pleased with our progress to date, and look forward to sharing results from this first Phase II study in patients undergoing colonoscopy later this year.”
Data from Phase I clinical pharmacology, dosing and safety studies were presented recently at the International Anesthesia Research Society 2016 Annual Meeting and International Science Symposium in San Francisco and Euroanaesthesia 2016 in London, Europe’s largest annual event of anesthesiology and subspecialties. Results showed that ABP-700 safely produces dose-dependent levels of sedation ranging from light to moderate to deep, with respiration being generally well preserved across all sedation levels. The research also showed that bolus and infusion doses of ABP-700 could be safely given with pre-and co-medications such as opiates and benzodiazepines, commonly used during procedural care and as an adjunct to induction of general anesthesia.
Commenting on the three Phase 1 studies which were presented, Professor Michel Struys, Professor and Chairman, Department of Anesthesiology, University Medical Center Groningen, Netherlands, and principal investigator for the ABP-700 Phase I program stated, “These three studies advance our understanding of the safety, pharmacology and tolerability of ABP-700 when given by bolus and infusion dose regimens, and when given in association with pre- and co-medications commonly used during procedural care and induction of anesthesia. Similar to our previously reported ANVN-01 study, these results show ABP-700 to be safe and generally well tolerated across a broad range of doses, dose regimens and alongside other medications used during procedural care of patients. Along with our recently completed ANVN-05 study, these data help to inform our dosing of ABP-700 for Phase 2 testing in both procedural sedation and induction of general anesthesia.”
In the US and EU, more than 60 million people undergo general anesthesia, including treatment with intravenous anesthetics. More than 120 million people undergo procedural sedation, at least 25% of which are administered with anesthesiologist supervision. Over the past decade, the number of surgical procedures performed has steadily increased and the proportion of those performed on an outpatient basis now exceeds 70% in most parts of the United States. At the same time, surgical care and procedural medicine have moved towards lighter anesthesia, minimal and focused procedural sedation, and teams that include many non-physician care providers. Throughout the world, there is pressure to provide high quality surgical care services with shorter stays to address the increasing costs and increasing demand for surgical care. In light of these trends, new agents need to be developed that are capable of producing highly specific depth of sedation or anesthesia, yet also be rapidly reversible.
ABP-700, an investigational product not approved for commercial use in any market, is a novel, positive allosteric modulator of the GABAA receptor currently being developed for the induction of general anesthesia and procedural sedation. ABP-700 is from a family of compounds invented by Dr. Douglas Raines at the Massachusetts General Hospital.
About the VERONA Program
Barbiturates were the first intravenous sedative-hypnotics and have origin with the synthesis of the chemical malonylurea by von Baeyer in 1864. The first clinically important drug of this class was barbituric acid or barbital, invented by von Mering and Fischer in 1903. When Fischer, the recipient of the Novel Prize in Chemistry in 1902, informed his friend and colleague von Mering that their compound barbitol worked, the latter was in the city of Verona, Italy. It was this communication between Fisher and von Mering in Verona which heralded the birth of a new class of drugs, the sedative hypnotics, to which ABP-700 is the most recent addition.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, U.S and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," "hopes," and "potential" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether our product candidates, including ABP-700, will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company will make regulatory submissions for its product candidates on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all,, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's quarterly report on Form 10-Q filed with the SEC on May 9, 2016 , which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
For The Medicines Company:
Bob Laverty, 973-290-6162
Vice President, Global Communications
Krishna Gorti, M.D., 973-290-6122
Vice President, Investor Relations