The first-in-human, double-blind, placebo-controlled study in 60 subjects was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABP-700 after single ascending intravenous bolus doses. Study results showed linearly dose proportional pharmacokinetics and pharmacodynamic effects which were rapidly reversible, consistent with pre-clinical animal studies. Adverse events were mild with the exception of one subject with moderate tachycardia. No serious adverse events were reported.
"We are very excited to study this new short-acting hypnotic-anesthetic drug for both anesthesia and sedation purposes," said Professor Michel Struys, principal investigator for the trial and Professor and Chair, Department of Anesthesiology, University Medical Center Groningen, Netherlands. "This first-in-humans study gave us a first impression of the rapid pharmacokinetic and dynamic characteristics of ABP-700. We will use the data to further optimize the dosing scheme."
"Anesthetic agents are fraught with all sorts of serious problems, including depressing breathing, lowering blood pressure, and even suppressing adrenal gland function," said Dr. Douglas E. Raines, MD, Anesthesiologist and Professor of Anesthesia, Massachusetts General Hospital and Harvard Medical School, and inventor of ABP-700. "After spending two decades researching how these agents work, my colleagues and I thought that we might be able to use what we had learned to design agents aimed at addressing these problems."
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.
"Although the development program for ABP-700 is early, we are excited about these findings, which we feel support continued clinical development of ABP-700 for both induction and/or maintenance of general anesthesia and procedural sedation," said Jason Campagna, MD, PhD, Senior Vice President, Health Science, Surgery and Perioperative Care, The Medicines Company.
Full results of ANVN-01 as well as preliminary results of ANVN-02, the ongoing Phase I infusion study, will be presented at an upcoming medical conference. Two additional Phase I dose optimization studies are in progress.
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 general anesthesia and procedural sedation. ABP-700 is from a family of compounds invented by Dr. Douglas Raines at the Massachusetts General Hospital, all based on existing anesthetics which are variants of etomidate.
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 3000 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, USA 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 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 ABP-700 on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, the Company's ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, 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 5, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.