Tris Pharma Inc., a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological disorders, recently said the Monmouth Junction-based company has been awarded a grant expected to provide up to $16.6 million over five years from the National Institute on Drug Abuse, part of the National Institutes of Health.
Through the Helping to End Addiction Long-term Initiative, NIH has awarded grants to fund the optimization of new therapies to prevent and treat opioid use disorder.
Under the grant funding, Tris will collaborate with experts at multiple global institutions to complete preclinical through Phase 2 studies evaluating cebranopadol for the treatment of OUD. 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.
Cebranopadol is an investigational, dual nociception/orphanin FQ peptide receptor and µ-opioid peptide receptor agonist. It 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.
“Opioid overdose, misuse and dependence have had a devastating impact on individuals, families and communities, currently affecting an estimated 3 million Americans and accounting for $35 billion in U.S. health care costs every year,” Ketan Mehta, founder and CEO at Tris Pharma, said. “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.
“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,” Joseph Grieco, vice president of clinical development, said. “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.”
