Startup Regulonix Licenses UA Non-Opioid Pain Drug Candidates

Testing has shown the compounds to be non-addictive, and more effective than morphine.
Nov. 1, 2017
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Read more about the work of Rajesh Khanna on the NaV1.7 channel, known as the "sodium highway."

May and Rajesh Khanna, inventors of the non-opioid drug candidates (Photo courtesy of Rajesh Khanna)
May and Rajesh Khanna, inventors of the non-opioid drug candidates (Photo courtesy of Rajesh Khanna)
Vijay Gokhale, co-inventor, co-founder and senior research scientist at the BIO5 Institute (Photo: Paul Tumarkin/Tech Launch Arizona)
Vijay Gokhale, co-inventor, co-founder and senior research scientist at the BIO5 Institute (Photo: Paul Tumarkin/Tech Launch Arizona)

Researchers in the University of Arizona College of Medicine – Tucson have invented a new class of non-opioid compounds to treat pain. Animal testing has shown that the drug candidates are more effective than morphine, non-addictive, and non-toxic at high doses. The UA has licensed the compounds to startup Regulonix. 

The team worked with Tech Launch Arizona, the office of the UA that commercializes inventions stemming from research, to patent the technology and develop the startup company strategy. The company's co-founders, who are also the inventors, include Rajesh Khanna, associate professor of anesthesiology and neuroscience and professor of pharmacology; May Khanna, assistant professor of pharmacology; and Vijay Gokhale, senior research scientist at the UA's BIO5 Institute

"Chronic pain is widely prevalent, and opioid misuse and overdose constitute major public health crises," Rajesh Khanna says, adding that "while opioids are unlikely to go away any time soon, our task is to arm physicians with viable alternative options to combat this marginalized condition."    

Chronic pain affects about 1.5 billion adults around the world. According to the team, each year people spend $14 billion on headache medications, $200 billion on backache medications and $189 billion on arthritis medications.  

Adding to the problem, the nation's opioid crisis has skyrocketed over the past 10 years. According to the Centers for Disease Control and Prevention, 78 Americans die each day from an opioid overdose. The Department of Health and Human Services has declared this a national emergency. 

The key to the UA technology is a focus on the NaV1.7 "sodium channel," a part of the nerve cell membrane that has been linked to human pain disorders, which is not the primary target for opioids. Most opioid drugs induce analgesia — the inability to feel pain — mainly by inhibiting multiple opioid receptors. They address the pain problem but also create a number of other effects, including an increased risk of addiction and overdose. 

The compounds selected for further development by Regulonix primarily affect the NaV1.7 sodium channel indirectly through a protein called CRMP2, or collapsing response mediator protein 2, leaving the other channels relatively unaffected and thus not creating the corresponding negative effects. 

The Department of Health and Human Services and the National Institutes of Health have awarded the company a Phase I STTR for $300,000 for development.  

Throughout the commercialization process, the Regulonix team has collaborated closely with Tech Launch Arizona, working closely with Lisa Lin, licensing manager for the UA College of Medicine – Tucson; Rakhi Gibbons, associate director for biomedical and life sciences licensing; and mentor-in-residence Michael Sember.  

"Being able to work with a group like the Regulonix team to address such a huge social and medical challenge has been wonderful," Gibbons says. "We're excited to be able to have a hand in bringing such an impactful technology to the world at such a critical moment in time."