Cessation Therapeutics Receives FDA Fast Track Designation for CSX-1004 for Prevention of Fentanyl and Fentanyl Analog Overdose
31 Oct 2023
Fast TrackImmunotherapyPhase 1
If approved, CSX-1004 would be the first FDA-approved therapy for prevention of fentanyl-related overdose
CHAPEL HILL, N.C.--(BUSINESS WIRE)-- Cessation Therapeutics, Inc. (“Cessation”), a clinical-stage biotechnology company advancing biologics that target substances of abuse, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CSX-1004, an investigational therapy for prevention of fentanyl-related overdose. CSX-1004 is a human IgG1 monoclonal antibody specific for fentanyl and fentanyl analogs and 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.
Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an investigational product can reach the market expeditiously. Features of Fast Track designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
“Fast Track designation by the FDA is an important milestone and recognizes the potential for CSX-1004 to help address an unprecedented public health crisis that claims a life every seven minutes in the United States,” said Andy Barrett, PhD, Chief Scientific Officer at Cessation. “We are encouraged by the FDA’s decision as it reflects the need for novel treatments that can potentially stem the tide of untimely fentanyl-related deaths.”
Fast Track designation was based, in part, on nonhuman primate data demonstrating that a single dose of CSX-1004 can block the life-threatening, respiratory depressant effects of high doses of fentanyl for up to 28 days. Cessation has initiated a Phase 1a, first-in-human study (NCT06005402) to evaluate the safety, tolerability, and pharmacokinetics of CSX-1004 in healthy volunteers.
About Cessation Therapeutics
Cessation Therapeutics is a clinical-stage pharmaceutical company working to develop novel immunobiologics designed to prevent and protect against overdose. With an initial focus on fentanyl, Cessation’s monoclonal antibodies can be adapted to target future synthetic opioids and other substances. Cessation has the potential to treat a range of substance use disorders and improve the lives of patients and families affected by the addiction crisis. Cessation was founded in 2018 by Mark Pearson and John D. Harkey, Jr., experienced, successful long-term biotech investors. Cessation has been financed through their investment firms Altamont Pharmaceutical Holdings, LLC and JDH Investment Management, LLC, respectively. For more information, please visit .
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