Cessation Therapeutics will be advancing its investigational monoclonal antibody to a Phase IIa study after a Phase Ia success in opioid substance abuse.
The clinical-stage biotech announced positive data from its Phase Ia trial (NCT06005402) of CSX-004 in prophylaxis against fentanyl-related overdose.
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The data was presented in an abstract and oral presentation at the College on Problems of Drug Dependence (CPDD) annual meeting in Montreal on 19 June.
The preliminary data showed that CSX-1004 is safe and well-tolerated in 32 healthy volunteers. There were 17 adverse events (AEs) reported, with 16 being determined as mild in severity. No serious AEs were reported. There were no dose-limiting toxicities reported.
Cessation says that the data also predicts early signs of efficacy for blocking fentanyl-induced respiratory depression.
The company has announced that it will advance CSX-1004 to a Phase IIa proof-of-concept trial. According to the company’s website, the Phase IIa trial will be initiated in the second quarter of 2024.
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By GlobalDataThe Phase IIa study will evaluate the efficacy of CSX-1004 in blocking the respiratory depressant effects of fentanyl in both healthy volunteers and patients with opioid use disorder.
Dr Brad Vince, CEO of Dr. Vince Clinical Research, where the Phase I study was held, said: “The opioid crisis in America, specifically with illegally manufactured fentanyl and fentanyl analogues, continues to take countless lives and decimate families and loved ones. CSX-1004, especially secondary to its exceptionally long half-life, has the potential to supply healthcare providers with another treatment and prevention option as they help combat the fentanyl epidemic in this country.”
CSX-1004 is an investigational, recombinant human immunoglobulin G (IgG)1λ monoclonal antibody which neutralises fentanyl in the bloodstream, preventing fentanyl from exerting its effects in the brain.
The drug gained Fast Track designation from the US Food and Drug Administration in October 2023. The company also received a grant from the US National Institutes of Health’s division, the National Institute on Drug Abuse (NIDA), to develop the drug.
Opioid crisis
According to data from the NIDA, there were 107,941 drug-involved overdose deaths reported in the US in 2022. Synthetic opioids, primarily fentanyl, were the main driver of drug overdose deaths with a more than 7.5-fold increase from 2015 to 2022.
In 2022, the Biden-Harris administration awarded more than $1.6bn to communities that were working to address their addiction and overdose crises.
The conventional approach to treating opioid addiction primarily relies on medication-assisted treatment, which combines medication with counselling and behavioural therapy. There are, however, alternative approaches being investigated to tackle the ongoing epidemic.
