The federal government supports the development of new medications and medical treatments through grants. They are awarded to research centers, universities, and companies willing to undertake comprehensive research and development projects for the benefit of the American public. Recently, the Institute of Human Virology at the University of Maryland won a $12 million grant to develop a new drug that curbs opioid cravings and the symptoms of opioid withdrawal.
Elements of the University of Maryland Grant
The new drug, ANS-6637, is the focal point of the Institute of Human Virology’s new grant project, but the overall project concerns more than just pharmaceutical testing. The Institute of Human Virology intends to put this new grant money toward researching effective opioid use disorder treatment techniques, study the spread of hepatitis C, HIV, and other infectious diseases from intravenous drug use, and test the efficacy of ANS-6637 in patients who experience opioid cravings.
The Dangers of Opioid Abuse
The United States is currently in the midst of an ongoing drug epidemic that has resulted in accidental drug overdoses becoming the leading cause of accidental deaths in the country. The Centers for Disease Control and Prevention (CDC) reported that opioid overdoses caused nearly 48,000 deaths in the United States in 2017. Their report also showed that opioid overdose deaths increased sevenfold from 1999 to 2017.
Maryland has experienced some of the worst effects of the ongoing opioid crisis, placing the state among the top five states with the highest levels of opioid abuse and opioid overdose-related deaths. From 1999 to 2016, the death rate from opioid use disorder in Maryland more than doubled the national average. In 2016, there were about 30 deaths per 100,000 residents in Maryland, while the national average hovered around 13 deaths per 100,000 residents. The Institute of Human Virology at the University of Maryland reported a sharp increase from 17.7 deaths per 100,000 residents in 2015 to 30 deaths per 100,000 residents in 2016.
Securing Funding for the New Grant
The opioid crisis started escalating in the mid-2000s and has now reached epidemic levels in the United States. These numbers spurred many legislators and even private companies to develop new methods for fighting the growing number of opioid addiction cases in the country.
Amygdala Neurosciences, Inc., a California-based pharmaceutical development company, is the primary financial backer for the recent $12 million grant to the University of Maryland’s Institute of Human Virology. Together, they are working in coordination with the National Institute of Health (NIH) to ensure the Institute of Human Virology can conduct thorough testing of new ways to treat opioid use disorder. The NIH developed their Helping to End Addiction Long-term (HEAL) Initiative in April of 2018. This grant is just one step in the plan to curb opioid use disorder in the United States.
U.S. lawmakers throughout the country have also proposed new legislative measures to help increase funding to the NIH and other organizations capable of researching and developing new addiction treatment methods. U.S. Congressional Representatives Elijah Cummings and Elizabeth Warren recently co-sponsored the proposition of new legislation to increase NIH funding, with a specific focus on curbing the ongoing opioid epidemic.
ANS-6637 Testing Results
The Institute of Human Virology reports that ANS-6637, the new opioid use disorder drug in development, is a selective ALDH2 inhibitor. This means the substance can effectively block the dopamine surge commonly associated with satisfying an opioid craving. Craving is an integral part of any addiction cycle, and the dopamine rush of securing and using a dose of one’s drug of choice is a key biochemical reason behind prolonged addictions.
ANS-6637 is promising due to the unique ability of the substance to prevent dopamine surges from drug use without interfering with baseline dopamine levels in the brain. ANS-6637 has already shown positive results in laboratory tests on animals, with researchers reporting that the surge of dopamine felt after using certain drugs creates the euphoria or “high” associated with illicit drug use, particularly opioids.
The new grant effectively enables human trials, and there is a pool of potential test subjects available to help the Institute of Human Virology to test and confirm the efficacy of ANS-6637. The study hopes to test the effects of this groundbreaking drug on actual current opioid users.
Research Team Leaders and Location
The National Institute of Health opted for the Institute of Human Virology at the University of Maryland to spearhead the new research into ANS-6637 due to the devastating effects opioid abuse has had on the local communities in the Baltimore and Washington, D.C. region. The lead researchers for this new project are Dr. Robert Gallo, Dr. Shyam Kottili, and Dr. Sarah Kattakuzhy. Dr. Gallo uncovered the link between HIV and AIDS in 1984, and he draws heavily on his experience with infectious diseases in the team’s research into the efficacy of ANS-6637.
This new project has a six-year timeline, beginning with preliminary trials and pre-clinical studies of pharmacokinetics at the National Institute of Health facilities in Washington, D.C. The Institute of Human Virology will handle the second phase of the project in both Washington, D.C. and Baltimore. This phase will focus on investigations of the efficacy of ANS-6637 as a treatment for opioid use disorder and safety for human consumption. The study will also explore the risk of death from infectious diseases associated with intravenous opioid use.