BALTIMORE--(BUSINESS WIRE)--The Institute of Human Virology (IHV) at the University of Maryland School of Medicine will lead a $12 million dollar project to improve the morbidity and mortality of people with opioid use disorder (OUD). Utilizing a novel compound, IHV researches will implement a series of investigations, entitled SEARCH, to evaluate the underlying mechanisms of craving reduction as a strategy to prevent opioid misuse, dependence, and relapse. The grant is awarded through the National Institutes of Health’s (NIH) Helping to End Addiction Long-term (HEAL) Initiative, made possible through groundbreaking funding from the U.S. Congress.
“We are pleased to have the opportunity through Dr. Shyam Kottilil’s terrific team here at the Institute to meaningfully address the critical issue of addiction,” said Robert Gallo, MD, The Homer and Martha Gudelsky Distinguished Professor in Medicine, co-founder and director, Institute of Human Virology at the University of Maryland School of Medicine and co-founder and director, Global Virus Network. “Dr. Kottilil and I recently published an op-ed in The Baltimore Sun outlining the importance of better equipping infectious disease specialists to concomitantly treat substance use disorders. This grant is an important step in doing just that.”
“My colleague, Senator Elizabeth Warren and I, introduced legislation this past spring to significantly boost federal funding to combat the rising opioid crisis in the U.S., which leads to tens of thousands of deaths each year,” said U.S. Representative Elijah Cummings (D-Md.). “Baltimore City, one of the hardest hit communities in this national crisis, is a prime location for these clinical trials. I am pleased that the NIH recognizes that the IHV, with its vast expertise, is well-positioned to lead these trials and begin to address the opioid epidemic devastating cities and towns across the nation.”
Nationally, 64,000 Americans died from opioid overdose in 2016, surpassing peak HIV-related deaths at the height of the HIV epidemic. Maryland has one of the fastest rising rates of opioid overdose death in the nation, from 17.7 deaths per 100,000 individuals in 2015, to 30 deaths per 100,000 individuals in 2016. In Baltimore, it is estimated that 11% of Baltimore City residents have a substance use disorder, which underscores the staggering drug overdose death rate of 112.9 deaths per 100,000 individuals in 2016. In 2016, 454 people died as a result of heroin overdose, outpacing the number of homicide-related deaths in the same year.
The investigational agent, ANS-6637, developed by Amygdala Neurosciences, is a selective ALDH2 Inhibitor that may prevent pathophysiologic dopamine surge and associated craving, without changes to basal dopamine. Given the role of craving in the cycle of addiction and relapse, this drug has the potential to be used as pharmacotherapy for any substance and behavior-based addiction.
“We are pleased to partner with the NIH to test this novel therapeutic in our research clinics, with the hope that we can help people living with substance use disorder better manage their disease,” said Shyam Kottilil, MBBS, PhD, professor of medicine, director, Division of Clinical Care & Research, Institute of Human Virology at the University of Maryland School of Medicine.
The six-year project comprises a comprehensive series of investigations led by IHV faculty. The initial investigation, a pre-clinical study of pharmacokinetics, will be conducted at the NIH in collaboration with NIH investigators. Subsequently, the IHV will lead a series of phase II investigations at research sites spanning Washington DC and Baltimore, to evaluate the safety and efficacy of ANS-6637 to reduce craving, drug use, and the risk of comorbid conditions including hepatitis C and HIV.
“While there are evidence-based strategies to reduce harm in individuals with OUD, including medication assisted treatment and syringe exchange, craving remains a major impediment to sobriety,” said Sarah Kattakuzhy, MD, assistant professor of medicine, Institute of Human Virology at the University of Maryland School of Medicine. “The SEARCH investigations will evaluate a new therapeutic mechanism of action, which if successful, could be part of a comprehensive therapeutic strategy that addresses both the physical and psychological symptoms of addiction. The SEARCH program will build upon our research expertise in high throughput phase II investigations, and our experience in hepatitis C treatment and harm reduction in persons with OUD, helping to take clinical care of this marginalized population into the future.”
About the Institute of Human Virology
Formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland and the University of Maryland Medical System, IHV is an institute of the University of Maryland School of Medicine and is home to some of the most globally-recognized and world-renowned experts in all of virology. The IHV combines the disciplines of basic research, epidemiology and clinical research in a concerted effort to speed the discovery of diagnostics and therapeutics for a wide variety of chronic and deadly viral and immune disorders - most notably, HIV the virus that causes AIDS. For more information, www.ihv.org and follow us on Twitter @IHVmaryland.