Cessation Therapeutics, a clinical-stage biotechnology company focused on advancing biologics targeting substances of abuse, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CSX-1004, an investigational therapy designed to prevent fentanyl-related overdose. CSX-1004 is a human IgG1 monoclonal antibody specifically designed for fentanyl and its analogs.
It operates by sequestering fentanyl molecules upon entry into the bloodstream, effectively neutralizing them before they can reach the brain and cause harm. Fast Track designation is intended to streamline drug development for serious and life-threatening conditions, allowing investigational products to reach the market more quickly.
Notable aspects of Fast Track designation include increased interactions with the FDA review team and potential eligibility for Accelerated Approval and Priority Review. The FDA's decision to grant Fast Track designation acknowledges CSX-1004's potential to address a significant public health crisis marked by a fentanyl-related death occurring every seven minutes in the United States.
This designation was influenced, in part, by nonhuman primate data demonstrating that a single dose of CSX-1004 can block the respiratory depressant effects of high doses of fentanyl for up to 28 days. Cessation Therapeutics has initiated a Phase 1a, first-in-human study (NCT06005402) to assess the safety, tolerability, and pharmacokinetics of CSX-1004 in healthy volunteers.
