Sorrento Therapeutics and Scilex Holding, a Majority Owned Subsidiary, Have Entered Into an Exclusive Licensing Term Sheet With Aardvark Therapeutics to Acquire Its ARD-301 For the Treatment of Chronic Pain, Fibromyalgia, and Chronic Long Haul Covid Syndr

SAN DIEGO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics (NASDAQ: SRNE, “Sorrento”) and Scilex Holdings Company (“Scilex”), a majority owned subsidiary of Sorrento, have entered into an exclusive licensing term sheet with Aardvark Therapeutics (“Aardvark”) to acquire Aardvark’s proprietary formulation, Delayed Burst Release Low Dose Naltrexone (DBR-LDN), or ARD-301, for the treatment of chronic pain, fibromyalgia, and chronic post-COVID syndrome (“long haul COVID” or “long COVID”) in multiple Phase 2 programs planned to be initiated this year.

Following execution of the definitive agreement between the parties, Scilex plans to work with Aardvark to initiate a new Phase 2 trial this year for fibromyalgia, which Scilex believes will be an important milestone for treating physicians, and most importantly for the estimated 10 million U.S. adults suffering from this chronic, frequently debilitating central pain condition with limited treatment options.¹ Approximately one-third of those diagnosed with fibromyalgia in the U.S. are reported to receive chronic prescription opioids, which is part of the opioid crisis, since opioids are not believed to be an effective solution for chronic central pain.² ARD-301 is comprised of a non-opioid, non-addictive therapy option that has been shown to have activity for improving a broad array of fibromyalgia symptoms in prior clinical studies with LDN. Currently, there are only three FDA approved pharmacologic treatments for fibromyalgia, but they have demonstrated limited efficacy and burdensome side effects in many patients.

COVID-19 is a global public health crisis with severe and potentially long-lasting effects. COVID-19 patients around the world have reported persistent suffering, including serious complications that can last for months after the acute infection resolves, and – even with vaccines – there is great a need for treatment options for Long Haul COVID.  According to a research letter published in the Journal of the American Medical Association (JAMA), more than 40 percent of COVID-19 survivors assessed in an Italian study still reported shortness of breath an average of 60 days following symptom onset.³ These data suggest that a significant percentage of COVID-19 survivors may be at risk for respiratory complications and other sequelae, which is a condition that is now colloquially referred to as “Long COVID.” “I look forward to working with Sorrento, Scilex Holding, and Aardvark Therapeutics to initiate a Phase 2 trial to explore potential benefit of ARD-301 for patients suffering from the sequelae of chronic post-COVID syndrome,” said Stephen Faraone, Ph.D., Distinguished Professor and Vice Chair for Research, Department of Psychiatry, SUNY Upstate Medical University, Syracuse, New York.