SAN DIEGO, June 26, 2023 — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company, today announced that its wholly owned subsidiary DMK Pharmaceuticals Corporation was the recipient of a grant from the National Institute on Alcohol Abuse And Alcoholism (NIAAA) of the National Institutes of Health (NIH) to support the development of a novel bifunctional small molecule for the treatment of Alcohol Use Disorder (AUD) (#R41AA030226).
Different types of drug addiction fall under the umbrella term of substance use disorders or SUD. Physicians have a better understanding of SUD and given recent research findings we now know that these conditions are treatable with effective medical interventions.1
“Our mission at Adamis Pharmaceuticals is to become the market leader on interventions for substance use disorders,” said Eboo Versi, MD, PhD, newly appointed CEO of Adamis Pharmaceuticals. “We already have an approved product (ZIMHI) and a clinical stage product candidate (DPI-125) for addressing the opioid crisis, but we also want to expand our development portfolio to include other SUD treatments in areas of high unmet need such as AUD. We had previously stated our goal was to continue getting non-dilutive funding from the government and this funding from NIAAA clearly helps to further this goal. The aim of this funded early-stage project is to use gold-standard preclinical assays to vet Adamis’ newly acquired molecules that possess the bi-functional attributes hypothesized to reduce excessive alcohol use. Given our library of about 750 novel small molecules, we have the ability to investigate several drug candidates to identify the best one to progress into clinical development.”
Like the opioid crisis, the national impact of alcohol use disorder continues to worsen. The pre-pandemic estimate of the cost of excessive alcohol use to the U.S. economy was $250 billion a year2; the social isolation and strain of the pandemic has exacerbated the severity of this problem. AUD affected 29.5 million Americans over the age of 12 in 20213 and co-use of alcohol continues to be associated with opioid overdose deaths. Adamis recognizes the urgent, unmet need to address the paucity of therapeutic options for patients dealing with AUD.
About the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIAAA is one of the 27 Institutes at the National Institutes of Health (NIH), the nation’s medical research agency. It conducts and funds research on the impact of alcohol use on human health and well-being. NIAAA’s mission is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder, across the lifespan.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a commercial stage neuro-biotech company primarily focused on developing and commercializing products for the treatment of opioid overdose and substance use disorders. Adamis’ commercial products approved by the FDA include ZIMHI® (naloxone) Injection for the treatment of opioid overdose, and SYMJEPI® (epinephrine) Injection for use in the emergency treatment of acute allergic reactions, including anaphylaxis. As a result of its recent merger transaction with DMK Pharmaceuticals, the Company is now focused on developing novel therapies for opioid use disorder (OUD) and other important neuro-based conditions where patients are currently underserved. The Company believes its technologies are at the forefront of endorphin-inspired drug design with its mono, bi- and tri-functional small molecules that simultaneously modulate critical networks in the nervous system. Adamis has a library of approximately 750 small molecule neuropeptide analogues and a differentiated pipeline that could address unmet medical needs by taking the novel approach to integrate with the body’s own efforts to regain balance of disrupted physiology. The Company’s lead clinical stage product candidate, DPI-125, is being studied as a potential novel treatment for OUD. Adamis also plans to develop the compound for the treatment of moderate to severe pain. The Company’s other development stage product candidates include DPI-221 for bladder control problems and DPI-289 for severe end stage Parkinson’s disease. For additional information about Adamis Pharmaceuticals, please visit our website and follow us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to anticipated future events or future results of operations, including, but not limited to, statements concerning the availability of government or non-governmental funding to support the company’s research and development programs and whether DPI-125, DPI-221, or DPI-289 or any other of the company’s product candidates will be successfully developed or commercialized. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis’ actual results to be materially different from the results anticipated by such forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Adamis cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2022, and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC’s website at http://www.sec.gov.
Adamis Investor Relations
1 NIDA. “Treatment and Recovery.” National Institute on Drug Abuse, 9 Mar. 2023, https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/treatment-recovery.
2 Jeffrey J. Sacks, Katherine R. Gonzales, Ellen E. Bouchery, Laura E. Tomedi, Robert D. Brewer, 2010 National and State Costs of Excessive Alcohol Consumption, American Journal of Preventive Medicine, Volume 49, Issue 5, 2015, Pages e73-e79, ISSN 0749-3797, https://doi.org/10.1016/j.amepre.2015.05.031
3 Alcohol Use Disorder (AUD) in the United States: Age Groups and Demographic Characteristics, NIAAA Website, Accessed June 12 2023, https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics#:~:text=Prevalence%20of%20Past%2DYear%20Alcohol%20Use%20Disorder%20(AUD)&text=According%20to%20the%202021%20National,AUD%20in%20the%20past%20year.&text=This%20includes%3A,12.1%25%20in%20this%20age%20group