Chapel Hill biotech secures OK for human tests of potential counter to fentanyl overdoses

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RESEARCH TRIANGLE PARK – The U.S. Food and Drug Administration has authorized Chapel Hill-based Cessation Therapeutics to begin a clinical trial on CSX-1004. The monoclonal antibody is designed to prevent fentanyl overdoses. The FDA’s action paves the way for the company to conduct its first clinical trials on humans.

“The FDA acceptance of an IND [Investigational New Drug] 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, Cessation Therapeutics CEO, in a statement. “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 to prevent the life-threatening respiratory depression caused by high doses of fentanyl. Clinical trials will begin this month in Kansas City, Missouri and will evaluate the drug’s safety and serum drug concentrations.

Before receiving FDA authorization, Cessation conducted a series of proof-of-concept studies in non-human primates. Study researchers found that a single infusion of CSX-1004 created an effective blockade against fentanyl’s potentially toxic effects.

“We look forward to evaluating CSX-1004 and its potential to have a meaningful impact on what has been identified as the single greatest health challenge facing the United States,” said Andy Barrett, Cessation’s chief scientific officer in a statement. “Given our prior findings in non-human primates, in which CSX-1004 provided robust and durable protection from the life-threatening respiratory depression caused by high doses of fentanyl, we are optimistic about the clinical potential of CSX-1004 in humans.”

In 2018, biotech venture investors Mark Pearson of Altamont Pharmaceutical Holdings and John D. Harkey of JDH Investment Management co-founded Cessation, the same year the National Institutes of Health launched its Helping to End Addiction Long-Term (HEAL) initiative. The development of CSX-1004 is partially funded by the National Institute of Drug Abuse (NIDA) through the HEAL program.

CSX-1004 was co-discovered by researchers at Scripps Research in La Jolla, California. Cessation obtained an exclusive worldwide license to CSX-1004 from Scripps in 2020. Today, basic research is conducted in La Jolla, while the team in Chapel Hill leads all clinical research.

(C) N.C. Biotech Center

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