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– Funding will support preclinical through Phase 2 studies, with preclinical research expected to initiate in Q4 2023 – 

MONMOUTH JUNCTION, NJ, August 28, 2023 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological disorders, today announced that the company has been awarded a grant expected to provide up to $16.6M over five years from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). Through the Helping to End Addiction Long-term^® Initiative (NIH HEAL Initiative^®), NIH has awarded grants to fund the optimization of new therapies to prevent and treat opioid use disorder (OUD).

Under their NIDA grant, Tris will collaborate with experts at multiple global institutions, including Marc Greenwald, Ph.D., of Wayne State University, and Professor Roberto Ciccocioppo of Unicam: Università degli Studi di Camerino, to complete preclinical through Phase 2 studies evaluating cebranopadol for the treatment of OUD. Cebranopadol is an investigational, dual nociception/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist.

“Opioid overdose, misuse and dependence have had a devastating impact on individuals, families and communities, currently affecting an estimated three million Americans and accounting for $35 billion in U.S. healthcare costs every year,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “We are honored that NIDA has chosen to support the further development of cebranopadol as a potential new treatment to help address this complex, growing and costly global problem.”

Current treatments for OUD have well-known limitations, including high risks for overdose, withdrawal symptoms and physical dependence. Activation of the NOP receptor has been shown in preclinical studies to block addictive drugs from producing drug-seeking behaviors. Further, cebranopadol has demonstrated reduced cocaine and heroin self-administration and drug-seeking behaviors, reinforcing its potential as an effective treatment for OUD.

Cebranopadol is the first and only full, dual NOP/MOP receptor agonist in clinical development. Tris is clinically evaluating the compound’s potential to provide safe and effective pain management without contributing to the global public health emergency of opioid addiction. Unlike FDA-approved opioids, the dual action of cebranopadol’s NOP/MOP receptor agonism modulates its addictive potential, as evidenced in multiple studies to date. In 2017, the FDA granted Fast Track Designation to cebranopadol for chronic low back pain.

Under the five-year NIDA grant, Tris Pharma will conduct preclinical studies to assess cebranopadol’s ability to deter the self-administration of Schedule II opioids, as well as to assess the respiratory function during co-administration of cebranopadol and Schedule II opioids in preclinical models. Additionally, the company will conduct clinical studies to assess the addictive potential of cebranopadol, as well as the dosage of cebranopadol needed to block withdrawal and subjective effects of opioid dependence.

“This NIDA award will help accelerate exploration of cebranopadol as a potential tool to address the opioid crisis, moving Tris closer to our goal of offering a novel and effective solution that could help change the trajectory of the countless lives afflicted by this disease,” said Joseph Grieco, M.S., Ph.D., vice president of clinical development. “We understand the urgency for new OUD treatment options, and I am optimistic about the potential of our upcoming NIDA-supported trials. We look forward to sharing updates on our progress.”

Research reported in this publication was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UG3DA059285. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 

About Cebranopadol (TRN-228)

Cebranopadol is the first and only full, dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist in clinical development for the treatment of moderate to severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a compelling and truly 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 abuse while still providing effective pain relief, and to block drugs of abuse from producing drug-seeking behaviors. In 2017, the FDA granted Fast Track Designation to cebranopadol for chronic low back pain. Cebranopadol’s profile has been well-characterized in pain management, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to traditional opioids with significantly less potential for abuse 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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Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

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