CHAPEL HILL, N.C.--(BUSINESS WIRE)--Cessation Therapeutics, Inc., (“Cessation”) a clinical-stage biotechnology company advancing biologics that target substances of abuse, announced today that the U.S. Food and Drug Administration (FDA) has authorized the company to initiate a clinical trial in the U.S. for CSX-1004, a monoclonal antibody designed specifically to prevent fentanyl overdose.
The clearance follows the FDA’s review and approval of Cessation’s Investigational New Drug (IND) application and serves as a launching point for Cessation’s first-in-human clinical trials. Cessation’s IND summarized years of the company’s nonclinical safety and manufacturing data and included a detailed description of the planned clinical study in humans.
“The FDA acceptance of an IND application for CSX-1004 and the upcoming clinical trial are meaningful steps in furthering our mission to introduce a potentially paradigm-shifting treatment to address the fentanyl epidemic in the U.S.,” said Tracy Woody, Chief Executive Officer at Cessation Therapeutics. “While fentanyl overdose is killing thousands of Americans every month, there are currently no FDA-approved products specifically designed to prevent an overdose.”
CSX-1004 works by sequestering fentanyl molecules as they enter the bloodstream, effectively neutralizing them in the blood before they reach the brain and preventing them from exerting their harmful effects.
CSX-1004 was co-discovered by Dr. Kim Janda, Professor of Chemistry at Scripps Research in La Jolla, California, and Dr. Paul Bremer, Director of R&D at Cessation, in the laboratory of Dr. Janda. Cessation obtained an exclusive worldwide license to CSX-1004 from Scripps in 2020. Development into a clinical candidate was subsequently spearheaded by Dr. Bremer alongside Dr. Andy Barrett, Chief Scientific Officer and Dr. Nick Jacob, Senior Scientist. Development was funded in part by a $7.1M grant (U01DA051071) from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) through the Helping to End Addiction Long-term Initiative (NIH HEAL Initiative), along with financing from experienced, successful long-term biotech investors, Altamont Pharmaceutical Holdings, LLC and JDH Investment management, LLC, as well as family offices.
“We look forward to evaluating CSX-1004 and its potential to have a meaningful impact on what has been identified as the single greatest public health challenge facing the United States,” said Andy Barrett, Chief Scientific Officer at Cessation Therapeutics. “Given our prior findings in nonhuman primates, in which CSX-1004 provided robust and durable protection from life-threatening respiratory depression caused by high doses of fentanyl, we are optimistic about the clinical potential of CSX-1004 in humans. This FDA clearance to initiate our first-in-human study is a major milestone in our clinical journey and we are excited to initiate the trial in August of this year.”
CSX-1004 is a recombinant human immunoglobulin G (IgG)1λ monoclonal antibody specific for fentanyl and related synthetic opioids. The therapeutic potential of CSX-1004 is favorable in terms of its safety profile in multiple animal species and its long-lasting ability to block the toxic effects of fentanyl in nonhuman primates at doses that would be lethal in humans. CSX-1004 is the first antibody-based therapy against fentanyl to gain IND approval.
About CSX-1004 Clinical Trials
Cessation’s first-in-human study will be conducted at Dr. Vince Clinical Research in Kansas City, MO, a clinical unit with deep experience in conducting first-in-human studies with monoclonal antibodies. The objective of the study is to evaluate the safety and serum drug concentrations of CSX-1004 in healthy subjects. Cessation plans to begin trials with the first cohort of subjects in August of 2023.
The opioid crisis is now a fentanyl crisis. Illicitly manufactured fentanyl and fentanyl analogs were involved in nearly 90% of all opioid-related deaths in 2022, when over 74,000 Americans (200 per day) died from a fentanyl-related overdose, making it the leading cause of death among adults aged 18 – 45 in the Unites States. There are currently no FDA-approved products for the prevention of fentanyl-related overdose.
About Cessation Therapeutics
Cessation Therapeutics is a clinical-stage biotechnology advancing biologics that target substances of abuse. With an initial focus on fentanyl, Cessation’s monoclonal antibodies can be adapted to target future synthetic opioids and other substances. Cessation's investigational products have the potential to treat a range of substance use disorders and improve the lives of patients and families affected by the addiction crisis. Biotech venture investors, Mark Pearson of Altamont Pharmaceutical Holdings, LLC and John D. Harkey, Jr. of JDH Investment Management, LLC co-founded Cessation in 2018. For more information on Cessation, please visit https://cessationtherapeutics.com
The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.
About Scripps Research
Scripps Research is an independent, nonprofit research institute ranked one of the most influential in the world for its impact on innovation by Nature Index. We are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of scientists at our Skaggs Graduate School, consistently named among the top 10 US programs for chemistry and biological sciences. Learn more at www.scripps.edu.