Findings Presented at PAINWeek 2024 Demonstrate Tris Pharma’s Investigational, First-in-Class Therapy Cebranopadol Provides Potent, Prolonged Pain Relief with Improved Safety Over Oxycodone

– Results showed that cebranopadol produces significantly less respiratory depression and other adverse respiratory effects compared to oxycodone –

– Cebranopadol is currently being evaluated in two registrational Phase 3 studies for the treatment of moderate-to-severe acute pain –

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced that data from a clinical study of cebranopadol suggest the investigational pain therapy produces potent and prolonged analgesia with 25% less respiratory depression than oxycodone. Cebranopadol is the company’s first-in-class dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist designed to treat multiple types of pain. The findings will be shared in a poster presentation on September 4, 2024, at the 2024 PAINWeek conference in Las Vegas.

“We’re pleased to share these important clinical findings at PAINWeek, which highlight the respiratory safety data of cebranopadol,” said James Hackworth, Ph.D., president, brand division at Tris Pharma. “We’ve seen the detrimental impact that opioids can have on patients who suffer from pain, and we’ve worked closely with regulatory agencies to conduct multiple studies that explore specific properties of cebranopadol’s efficacy and safety profile. Based on results from these studies, we have now advanced cebranopadol into two pivotal Phase 3 studies and look forward to sharing data from these studies once they are available.”

Findings shared in the PAINWeek 2024 presentation titled “The Effects of Cebranopadol 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 significantly 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.

Respiratory depression, which is mediated by activation of the MOP receptor, is a life-threatening complication that can occur following opioid administration. In the double-blind, placebo-controlled study that will be presented at PAINWeek, investigators randomized 30 healthy volunteers over a four-week treatment period to receive cebranopadol or oxycodone at supratherapeutic doses (i.e., doses that are greater than the therapeutic concentration) or placebo. The trial specifically evaluated both cebranopadol’s and oxycodone’s impact on respiratory depression using a ventilatory response to hypercapnia model, the ability to produce analgesia and the potential presence of a respiratory depression ceiling effect for cebranopadol at higher doses.

“Respiratory depression is one of the most life-threatening and dangerous side effects of opioid use and can lead to slow, shallow and irregular breathing or even death,” said lead study author Simone Jansen, M.D., Leiden University Medical Center, Leiden, The Netherlands. “These cebranopadol data are encouraging, because they support its overall safety profile, suggesting that cebranopadol’s novel mechanism of action uniquely delays the onset of respiratory effects and produces less respiratory depression compared to oxycodone. This delayed onset has multiple advantages, including extending the timeframe for any medical interventions, if needed, and thereby could potentially help physicians feel more confident in prescribing the medication if it is approved.”

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 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 or addiction while still providing effective pain relief, and the potential to block drugs of abuse from producing drug-seeking behaviors. Studied in over 30 clinical trials in over two thousand patients, cebranopadol’s profile has been well-characterized in pain management studies. It has demonstrated positive clinical results in acute pain, chronic pain, and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, 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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