CSX-1004 IV / Cessation Therap - LARVOL DELTA

Development of a Subcutaneous Formulation of CSX-1004 Mab for Fentanyl Overdose Prevention (CPDD 2025) - No abstract available

Safety, Tolerability, and Pharmacokinetics of CSX-1004 (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Cessation Therapeutics, Inc. | Phase classification: P1a ➔ P1 | Recruiting ➔ Completed

Phase classification • Trial completion • CNS Disorders • Substance Abuse

First-In-Human Study of the Safety, Tolerability and Pharmacokinetics of CSX-1004, an Investigational Anti-Fentanyl Monoclonal Antibody (CPDD 2024) - "CSX-1004 was generally well-tolerated with only infrequent and mild AEs. The pharmacokinetic profile is consistent with a once-monthly product that can potentially block or attenuate the toxic effects of fentanyl and fentanyl analogs."

Clinical • P1 data • PK/PD data • CNS Disorders • Constipation • Contact Dermatitis • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Insomnia • Pain • Sleep Disorder

Comparison of Intravenous vs Subcutaneous Administration of the Monoclonal Antibody, CSX-1004 That Blocks Fentanyl’s Effects in Squirrel Monkeys (CPDD 2024) - "In all studies, both 40 and 10mg/kg CSX-1004 produced a ~14- and ~5-fold rightward shift in the fentanyl dose-response function, respectively, but did not block the effects of other μ-opioid agonists like morphine, oxycodone, and alfentanil. Taken together, these studies provide strong evidence that the monoclonal antibody CSX-1004 could be a promising treatment in preventing fentanyl overdose while not disrupting the efficacy of other opioids often prescribed for pain management. Ongoing studies are evaluating whether CSX-1004 precipitates observable signs of opioid withdrawal to a lesser degree than naltrexone in fentanyl-dependent monkeys."

Addiction (Opioid and Alcohol) • Pain • Substance Abuse

Investigation of monoclonal antibody CSX-1004 for fentanyl overdose. (PubMed, Nat Commun) - "Furthermore, treatment with CSX-1004 produces up to a 15-fold potency reduction of fentanyl in NHP respiration, antinociception and operant responding assays without affecting non-fentanyl opioids like oxycodone. Taken together, our data establish the feasibility of CSX-1004 as a promising candidate medication for preventing and reversing fentanyl-induced overdose."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Psychiatry

Safety, Tolerability, and Pharmacokinetics of CSX-1004 (clinicaltrials.gov) - P1a | N=32 | Recruiting | Sponsor: Cessation Therapeutics, Inc.

New P1 trial • CNS Disorders • Substance Abuse