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Flying Under the Radar, Tris Pharma Builds Strong Pipeline in Pain, ADHD, Neurological Disorders

By Alex Keown
May 16, 2023

In the continual wake of the opioid crisis gripping the nation, New Jersey-based Tris Pharma is developing a pipeline of pain treatments that are expected to be much safer than currently available products.

Topping the company’s pipeline of experimental pain treatments is cebranopadol, a novel, dual nociceptin/orphanin FQ peptide (NOP) receptor and μ-opioid peptide (MOP) receptor agonist Tris Pharma gained in its 2021 acquisition of Park Therapeutics. In December 2022, Tris Pharma reported topline data from a clinical study that showed high doses of cebranopadol are less likely to be abused in comparison to immediate release (IR) formulations of both tramadol and oxycodone, two commonly-prescribed pain treatments. That study provides Tris’ rapidly-expanding leadership team with confidence as the company plans Phase III efficacy and safety trials of cebranopadol.

Ketan Mehta, founder and chief executive officer of Tris Pharma, told BioBuzz he was excited about the potential of cebranopadol when Tris acquired Park Therapeutics. Not only does it seem to be effective against multiple types of pain, acute, chronic and even neuropathic, but the experimental drug is also showing itself to be safe. He said cebranopadol is demonstrating the potential to provide a novel alternative to traditional opioids. The drug has strong analgesic properties and a minimal potential for abuse and physical dependence.

Ketan Mehta, Founder and CEO of Tris Pharma (SOURCE: Tris Pharma)

These make it a very appealing product with full ability to reduce pain without some of the risks. This could be a really important drug for patients,” said Mehta, who first began his company in the basement of his home.

It is estimated that approximately 50 million people in the United States suffer from chronic pain, which is classified as pain that lasts longer than 12 weeks despite medication or treatment. Mehta said these patients who have pain that is not well-managed are in need of a treatment that is effective with low chances of abuse. He believes cebranopadol can fill that need.

Mehta also noted that cebranopadol is a new class of drug. Its dual agonist nature is a unique asset that he believes will be an attractive alternative for treating physicians should its planned Phase III trial meet its clinical endpoints. 

Although Tris has not disclosed its timeline for the Phase III trial, Marc Lesnick, PhD, chief development officer at Tris and a cofounder of Park Therapeutics, also told BioBuzz the study will be designed to demonstrate efficacy and safety compared to currently available products. The company wants to take a robust data package to the FDA when it seeks approval, he said.

Cebranopadol, which was granted Fast Track designation by the FDA, is being assessed as a potential treatment for acute and chronic pain, as well as neuropathic pain. Although neuropathic pain is more challenging to treat, Lesnick, who joined Tris this month and now oversees R&D, clinical and regulatory affairs at the company, said data from their clinical studies suggests cebranopadol is “quite effective in neuropathic pain.

Marc Lesnick, PhD, CDO of Tris Pharma (SOURCE: Tris Pharma)

In addition to cebranopadol, Tris Pharma is also developing TRN-261 a non-opioid drug candidate for multiple indications within acute and chronic pain. Tris licensed the asset in 2022 after its previous developer failed to gain approval from the FDA in a non-pain indication. In its announcement at the time, Tris said several studies of TRN-261 established proof of concept within both acute and chronic pain conditions for which only opioid-based treatment options exist today.

Alongside its pain portfolio, Tris also has a distinct focus on developing treatments for ADHD. In 2021, Tris Pharma won approval for Dynavel XR (amphetamine), an extended release once-per-day tablet, for the treatment of ADHD in patients 6 years and older.

The company is also prepping to file a New Drug Application for TRN-148, another ADHD asset later this year, Mehta said.

Mehta said ADHD is a well-diagnosed disease but there are still gaps in treatment options. TRN-148can fill one of those gaps if it is approved, he said.

Although Tris has multiple approved products in its arsenal, the company has largely flown under the radar. Mehta and Lesnick both believe that will soon change.

Mehta said he has worked one day at a time to take the company from its humble beginnings in the basement of his home to where it is today, a biopharmaceutical business with multiple approved products.

“There’s a significant pipeline at this company. It’s an exciting place to be. I think you’ll be seeing a lot of stuff from Tris in the coming years,” Lesnick said.