Cessation Therapeutics Announces Oral Presentation of Preliminary Findings from First-in-Human Study of Anti-Fentanyl Monoclonal Antibody, CSX-1004
2024年6月20日 - 12:30AM
ビジネスワイヤ(英語)
Data presented at the annual meeting of the
College on Problems of Drug Dependence
CSX-1004 was well-tolerated across the entire
dose range, with no dose-limiting toxicities
CSX-1004 is advancing to a Phase 2 Study
Cessation Therapeutics, Inc. (“Cessation”), a clinical-stage
biotechnology company advancing biologics that target substances of
abuse, today announced the presentation of preliminary data from
its Phase 1a first-in-human study of CSX-1004, an investigational
monoclonal antibody for prophylaxis against fentanyl-related
overdose.
The following abstract is being presented as an oral
presentation at the annual meeting of the College on Problems of
Drug Dependence (CPDD) in Montreal on June 19 at 11:30 am ET. The
preliminary data showed that CSX-1004 is safe and well-tolerated
under the conditions tested. The exposure data were also predictive
of efficacy for blocking fentanyl-induced respiratory depression.
CSX-1004 will advance to a Phase 2 proof-of-concept study.
First-in-Human Study of the Safety, Tolerability and
Pharmacokinetics of CSX-1004, an Investigational Anti-Fentanyl
Monoclonal Antibody
Authors: B. Vince, A. Barrett, N. Jacob, P. Bremer, S. Hull
Date/Time: June 19, 2024 (11:30 am ET)
Preliminary results indicate that CSX-1004 was generally
well-tolerated across the dose range tested, with no dose-limiting
toxicities. Of the 17 total adverse events (AEs) reported, 16 (94%)
were rated as mild in severity. There were no serious AEs. Further,
there were no clinically significant laboratory abnormalities,
effect on vital signs, or ECG findings. The profile of CSX-1004
exposure in serum was consistent with other IgG monoclonal
antibodies, with a fast distribution phase and slower elimination
phase yielding a multi-week half-life. For at least one month
post-dosing, serum concentrations of CSX-1004 were greater than
those demonstrated to block life-threatening fentanyl-induced
respiratory depression in nonhuman primates. There was no evidence
of immunogenicity (i.e., development of anti-drug antibodies) in
blood samples analyzed to date.
“We are encouraged with the safety profile and overall
performance of CSX-1004 in this initial Phase 1 study,” said Andy
Barrett, PhD, President and Chief Scientific Officer at Cessation
Therapeutics. “The finding that serum concentrations of CSX-1004
remained above a minimum threshold for blocking fentanyl-induced
respiratory depression for an extended period of time provides
added confidence in the capabilities of the molecule. We are
advancing this potentially groundbreaking therapy into Phase 2
clinical development.”
“The opioid crisis in America, specifically with illegally
manufactured fentanyl and fentanyl analogs, continues to take
countless lives and decimate families and loved ones,” stated Dr.
Brad Vince, CEO & Chief Medical Officer of Dr. Vince Clinical
Research. “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.”
In this Phase 1a randomized, placebo-controlled, single
ascending dose study (NCT06005402), 32 healthy subjects were
enrolled. Four doses of CSX-1004 were tested sequentially,
beginning with the lowest dose: 1.0, 3.0, 10 and 30 mg/kg. Eight
subjects in each cohort were randomized to receive CSX-1004 or
placebo in a 3:1 ratio. After each cohort completed dosing, a
Safety Monitoring Committee (SMC) reviewed the blinded data to
approve escalation to the next higher dose. The trial was conducted
at Dr. Vince Clinical Research in Overland Park, KS.
A Phase 2a proof-of-concept study is planned that will evaluate
the ability of CSX-1004 to block the respiratory depressant effects
of fentanyl in repeated challenges over 28 days in healthy
volunteers and patients with Opioid Use Disorder.
About CSX-1004
CSX-1004 is an investigational, recombinant human immunoglobulin
G (IgG)1λ monoclonal antibody specific for fentanyl and related
synthetic opioids. CSX-1004 sequesters and directly neutralizes
fentanyl in the bloodstream, preventing fentanyl from exerting its
effects in the brain, including the brain’s respiratory centers.
CSX-1004 gained FDA Fast Track designation in October 2023 and is
being developed for prophylaxis against fentanyl-related
overdose.
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, as well as grant support for the
National Institute on Drug Abuse (NIDA). For more information,
please visit www.cessationtherapeutics.com.
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