Case Western Reserve University and Atelerix Life Sciences Inc., a Charlottesville, Virginia-based biotechnology company, have signed a two-year option to license a novel family of small molecules called Active Thiol-Based Compounds (ATBC’s) to prevent or reverse life-threatening opioid-related side effects.
The lead compound, ATLX–0199 (also called sudaxine), will be first targeted at opioid-induced respiratory depression (OIRD) in the hospital setting.
A recent study by the medical technology company Medtronic found that 46% of surgical patients receiving opioids for post-operative pain-relief suffer one or more episodes of OIRD, presenting perhaps the most significant obstacle to discharge from intensive care units and the hospital generally.
“No compound now on the market is able to reverse OIRD without also eliminating pain relief—an unacceptable trade-off in the hospital setting,” said David Kalergis, Atelerix CEO, co-founder and biotechnology entrepreneur. “This unmet need is well-recognized by medical practitioners, speeding the prospect of rapid adoption and reimbursement in this potential $1 billion market.”
The ATBC family and ATLLX-0199 are the result of several decades of collaborative scientific discovery and research among the company’s three co-founders: Stephen Lewis, a professor in the Department of Pediatrics at the Case Western Reserve School of Medicine, Benjamin Gaston, formerly of Case Western Reserve and now Billie Lou Wood Professor of Pediatrics at Indiana University’s School of Medicine, and James Bates, associate professor of Anesthesia at the University of Iowa’s Carver College of Medicine. Bates will become chief medical officer of Atelerix.
Development of the technology has been supported by funding and technical assistance from the National Institutes of Health, Harrington Discovery Institute at University Hospitals and the National Heart, Lung, and Blood Institute’s Catalyze Program.
The ATBC technology harnesses new, cutting-edge understanding of the molecular pathways involved in the effects of opioids, both as a pain reliever and a source of life-threatening side-effects like suppressed breathing. Rather than affecting the opioid receptors directly, they target the inhibition of pathways responsible for the side effects, allowing a more selective therapeutic intervention.
Studies on animal models have shown that ATLX–0199 can be injected intravenously to immediately reverse the negative effects of opioids on breathing without causing withdrawal or reversing the effects of pain control. Long-term, the company expects to expand the technology for use in trauma and overdoses, as well as administering the drug nasally, through patches or other routes.
“As a practicing anesthesiologist, I deal with the problem of opioid-induced depression of breathing in my patients every day,” Bates said. “In my new role as chief medical officer of Atelerix Life Sciences, I will be directly involved in developing a solution to this serious unmet medical need by helping speed sudaxine through the U.S. Food and Drug Administration-approval process and into widespread use in the hospital setting.”
The two-year option to license agreement, managed through Case Western Reserve’s Technology Transfer Office (TTO), will allow pre-clinical testing of the technology, including safety profiling and feasibility of scaled-up manufacturing.
“After several years of supporting this project within the university, we believe our timely partnership with Atelerix will provide a product that will address the real needs of patients receiving opioids,” said Stephanie Weidenbecher, TTO’s senior licensing manager. “Follow-on programs in trauma, military and overdose settings for sudaxine and other molecules in the ATBC family will present comparable opportunities.”