NIH awards 5-year, $16.6M grant to advance cebranopadol for opioid use disorder

Key takeaways:

• A 5-year, $16.6 million grant will allow Tris Pharma to study cebranopadol’s potential to provide safe, effective pain relief with reduced risk for abuse.
• Funding will support preclinical through phase 2 trials.

The NIH, through its Helping to End Addiction Long-Term initiative, has awarded Tris Pharma a grant of up to $16.6 million over 5 years to advance cebranopadol for the treatment of opioid use disorder.

According to a press release from Tris Pharma, the grant from the National Institute on Drug Abuse (NIDA) will allow the company to collaborate with global experts, including Marc Greenwald, PhD, of Wayne State University, and Roberto Ciccocioppo of the University of Camerino in Italy, to complete preclinical through phase 2 studies of cebranopadol.

The investigational treatment, a dual nociception/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist, will be evaluated for its addictive potential and to determine the proper dosage to block withdrawal and effects of opioid dependence.

“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. health care costs every year,” Ketan Mehta, Tris founder and CEO, said in the release. “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.”

Cebranopadol is the first and only full, dual NOP/MOP receptor agonist in clinical development, the release stated, and was granted fast track designation by the FDA in 2017 for chronic low back pain. With its NOP/MOP receptor agonism, shown in multiple studies to regulate addictive potential, cebranopadol could provide pain relief equivalent to traditional opioids with significantly less potential for abuse or risk for physical dependence, addiction or overdose.

“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, MS, PhD, vice president of clinical development at Tris, said in the release.