Tris Pharma Presents New Clinical Data Demonstrating Robust Safety and Efficacy of Investigational, First-in-Class Therapy Cebranopadol for Treatment of Pain
05 Agosto 2024 - 11:01PM
Business Wire
– Results shared at International Association
for the Study of Pain (IASP) 2024 World Congress on Pain
demonstrate that cebranopadol produces potent and prolonged pain
relief with 25% less respiratory depression and significantly
slower onset of effect with fewer respiratory adverse effects
compared to oxycodone –
– Findings highlight therapeutic potential of
cebranopadol, an investigational treatment with a promising, new
mechanism of action designed to fill treatment gaps as a novel
alternative to opioids for moderate-to-severe pain –
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical
company focused on attention deficit hyperactivity disorder (ADHD),
pain, addiction and neurological disorders, today announced new
clinical data demonstrating that cebranopadol, a dual
nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide
(MOP) receptor (dual-NMR) agonist, produces significantly less
respiratory depression than oxycodone. The findings will be
highlighted in a poster session on August 7, 2024, at the
International Association for the Study of Pain (IASP) 2024 World
Congress on Pain in Amsterdam.
“The study findings that will be shared at IASP 2024 offer
clinically meaningful evidence that cebranopadol can provide
effective and equal pain management with reduced potential of
respiratory depression as compared to oxycodone,” said James
Hackworth, Ph.D., president, brand division at Tris Pharma. “As a
first-in-class, dual-NMR agonist in development to treat
moderate-to-severe pain, cebranopadol has the potential to
significantly reduce side effects associated with MOP-related
agonism while simultaneously lessening MOP-related abuse potential
and dependence. These new respiratory data add to the growing body
of evidence that supports cebranopadol’s potential as a safer
alternative to opioids, and we plan to initiate Phase 3 studies
very soon.”
Mediated by activation of the MOP receptor, respiratory
depression is a life-threatening complication that can occur
following opioid administration. The clinical study being presented
at IASP compared cebranopadol to oxycodone at supratherapeutic
doses (i.e., doses that are greater than the therapeutic
concentration). The trial specifically evaluated both
cebranopadol’s and oxycodone’s impact on respiratory depression,
ability to produce analgesia, the potential presence of a ceiling
effect for cebranopadol at higher doses, and the evaluation of
significant respiratory depression using a model for testing
ventilatory response to hypercapnia. In the double-blind,
placebo-controlled study, investigators randomized 30 healthy
volunteers over a four-week treatment period to receive
cebranopadol, oxycodone or placebo.
Summary of Key Findings Presented at IASP 2024
Findings shared in the IASP 2024 poster presentation titled
“Cebranopadol effects on ventilatory drive, central nervous system,
and pain,” demonstrate that NOP receptor activation with
cebranopadol effectively attenuates respiratory depression and that
its dual-NMR agonism produces potent, long-lasting analgesia. Key
study results include:
- At equianalgesic doses, cebranopadol produces 25% less
respiratory depression compared to oxycodone.
- Treatment with cebranopadol presents a longer time to impact on
respiratory parameters compared to oxycodone, allowing for the
gradual accumulation of arterial CO2 and mitigating the full
manifestation of respiratory depression.
- Cebranopadol achieved prolonged analgesic effects with gradual
onset and offset.
- Despite having a longer duration of effect, cebranopadol
produces fewer respiratory adverse events over 24 hours, including
apnea, respiratory depression and oxygen saturation decrease,
compared to oxycodone.
“The delayed onset of respiratory effects as evidenced in this
study highlights the differentiating characteristic of cebranopadol
to significantly reduce MOP-related side effects frequently
experienced with opioids,” said study author Albert Dahan, M.D.,
professor of anesthesiology, Leiden University Medical Center,
Leiden, The Netherlands. “These results reinforce the safety
profile of cebranopadol by demonstrating that it gives the body
time to adjust its breathing, which in turn may aid in delivering
both a safe and effective pain management solution to patients.
Combined with data from previous clinical and preclinical studies
of cebranopadol, these findings also suggest a ceiling of
respiratory depression may exist in humans and bring us closer to
offering a better therapeutic for acute and chronic pain.”
About Cebranopadol (TRN-228)
Cebranopadol is an investigational, first-in-class dual
nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide
(MOP) receptor (dual-NMR) agonist for the treatment of
moderate-to-severe pain, as well as opioid use disorder (OUD).
Cebranopadol offers a compelling and unique mechanism of action
that takes advantage of the inherent properties of the NOP
receptor, which has demonstrated both the potential to lessen the
risk of misuse while still providing effective pain relief, and the
potential to block drugs of abuse from producing drug-seeking
behaviors. The FDA granted Fast Track Designation to cebranopadol
for chronic low back pain. Cebranopadol’s profile has been
well-characterized in pain management studies, and if approved, it
could become the first and only pain-relief therapy with the
demonstrated ability to provide efficacy equivalent to opioids with
significantly less potential for misuse or risk of physical
dependence, addiction or overdose.
About Tris Pharma
Tris Pharma is a privately held, innovation-driven
biopharmaceutical company that is applying its drug development
capabilities and proprietary technologies to transform the
treatment of ADHD, pain and neurological disorders, including
addiction and diseases of the central nervous system. Tris is an
established commercial organization with a robust portfolio of
best-in-class ADHD products and a promising pipeline of
differentiated, near-term drug candidates. More information is
available at www.trispharma.com and on LinkedIn
@TrisPharma.
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Company Contact Cheryl Patnick Tris Pharma, Inc.
cpatnick@trispharma.com
Media Contact Laura Morgan Sam Brown, Inc. 951.333.9110
lauramorgan@sambrown.com