Tris Pharma Launches Phase 3 Trials for Cebranopadol in Pain Treatment

Tris Pharma, Inc., a biopharmaceutical company based in Monmouth Junction, New Jersey, has announced the commencement of its pivotal Phase 3 clinical trials—ALLEVIATE-1 and ALLEVIATE-2—evaluating cebranopadol for treating moderate-to-severe acute pain. This investigational therapy is noted for its novel dual mechanism of action, targeting both the nociceptin/orphanin FQ peptide (NOP) receptor and the µ-opioid peptide (MOP) receptor. This dual approach aims to address various types of pain more effectively while minimizing the risk of significant side effects typically associated with conventional opioid treatments.

Ketan Mehta, the founder and CEO of Tris Pharma, highlighted the essential need for better pain management solutions for millions who suffer from debilitating pain daily. Mehta emphasized that the initiation of these Phase 3 trials marks a crucial step toward providing a highly effective and safe pain management option. The company aims to share the study results as soon as they become available.

The two clinical trials, ALLEVIATE-1 and ALLEVIATE-2, are designed to assess the efficacy of cebranopadol in two different surgical contexts: abdominoplasty and bunionectomy. Collectively, these studies will include over 500 patients across various sites in the United States. The outcomes from these trials will contribute to the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the approval of cebranopadol.

Dr. Jeffrey Gudin, a professor at the University of Miami Miller School of Medicine, remarked on the limitations of existing pain medications, which either fail to effectively alleviate pain or pose significant risks of side effects, misuse, and addiction. Gudin expressed optimism about cebranopadol’s potential to offer a transformative pain management solution, given its innovative mechanism of action.

If approved, cebranopadol would become the first dual-NMR agonist available globally. The investigational drug is engineered to utilize the body's natural pain modulation mechanisms, combining the analgesic benefits of the NOP receptor with those of the MOP receptor. This dual action could potentially deliver opioid-like pain relief with significantly reduced risks of addiction, misuse, and severe side effects.

Cebranopadol has already undergone extensive evaluation, with over 30 clinical trials involving more than 2,000 patients. Data from these trials indicate that cebranopadol effectively reduces both acute and chronic pain, including neuropathic pain, while mitigating many of the adverse effects commonly associated with opioids. Additionally, the investigational therapy may present a lower risk of addiction and overdose compared to traditional opioids.

The ALLEVIATE-1 trial is a multicenter, randomized, double-blind, placebo-controlled study, enrolling up to 300 patients across six sites in the United States. Its primary goal is to evaluate the analgesic efficacy of cebranopadol compared to a placebo for managing moderate-to-severe pain following abdominoplasty. Secondary objectives include the assessment of the need for rescue medication, early discontinuations, and overall patient evaluation of the study medication.

Similarly, the ALLEVIATE-2 trial will enroll up to 240 patients across eight sites in the United States. This multicenter, randomized, double-blind, placebo- and active-controlled study will focus on evaluating the analgesic efficacy of cebranopadol for managing pain following bunionectomy. Secondary objectives include the usage of rescue medication and the evaluation of cebranopadol's safety and tolerability compared to oxycodone.

Cebranopadol (TRN-228) stands out as a first-in-class investigational therapy targeting both NOP and MOP receptors. This dual approach aims to mitigate pain effectively while reducing the risk of misuse and addiction. The FDA has granted Fast Track Designation to cebranopadol for chronic low back pain. If approved, it could be the first pain-relief therapy that offers efficacy equivalent to opioids with significantly less risk of misuse, addiction, or overdose.

Tris Pharma is dedicated to innovation in the biopharmaceutical sector, particularly in the treatment of ADHD, pain, addiction, and central nervous system disorders. The company boasts a diversified portfolio of ADHD products and a promising pipeline of drug candidates poised for near-term success.