Sorrento's Scilex Initiates Phase 2 Study To Evaluate Safety And Efficacy Of SP-103 In Subjects With Acute Low Back Pain

• Dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% in subjects with moderate to severe acute lower back pain (LBP). The trial will enroll 80 patients with acute lower back pain.
• SP-103 is a pharmacologically validated drug candidate and has the potential as a best-in-class agent of pain treatment for low back pain without the limitations of current therapies, including the addictive potential of opioids.
• An estimated 65 million adults in the U.S., or 25% of U.S. adults, suffer from acute low back pain1 with a total potential global market opportunity of approximately $10.0 billion by 2026 (Brand Essence Research 2020).

PALO ALTO, Calif., May 18, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company ("Scilex"), a Sorrento Company (nearly 100% or over 99.9% majority-owned subsidiary of Sorrento Therapeutics, Inc.) (NASDAQ:SRNE, ", Sorrento", ))))) and a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, announced dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 in subjects with acute LBP.

"It is a significant milestone for Scilex to begin the next development phase of the triple-dose strength of FDA-approved ZTlido® (lidocaine topical system) 1.8% ("ZTlido®"). Most of the off-label use of topical lidocaine products is for the treatment of LBP. However, the low dosage strength of existing lidocaine products does not always provide sufficient pain relief3. A higher concentration of lidocaine per given area of a patch may lead to better efficacy and provide evidence for registering SP-103 for the treatment of acute LBP in patients with mostly superficial muscular pain. Based on the favorable data from the pharmacokinetics study, Scilex is advancing this program into Phase 2 with initiation of the study in LBP patients," said Dr. Dmitri Lissin, Chief Medical Officer of Scilex.

"It is exciting to see a product in development with a higher concentration of lidocaine and great adhesion qualities. This product may greatly help patients with muscular pain in the lower back, and may also help to avoid use of systemic medications, associated with systemic side effects, including opioids," said Alan Miller, M.D., Director of Interventional Pain Management at Coastal Spine & Pain Center, Fernandina Beach, Florida.

Scilex's current marketed product, ZTlido (lidocaine topical system), has label claims regarding superior adhesion qualities as compared to other products and SP-103 has the same adhesion characteristics.

"SP-103 has the potential to meet our core goal of developing best-in-class pain management therapies to significantly improve the lives of patients with LBP who are seeking new effective treatments. Scilex is excited about this potentially safe and effective treatment without the limitations of currently used off-label therapies, including opioids with risks of abuse and addiction. ZTlido is already approved for use of up to 3 patches at once with proven safety. We believe that one SP-103 patch with the same systemic exposure to lidocaine may have a good probability of efficacy in this indication with a very low risk for safety concerns," said Jaisim Shah, Chief Executive Officer of Scilex.

Scilex is developing SP-103 to be a triple-strength, non-aqueous lidocaine topical system for the treatment of acute LBP. Acute LBP can range in intensity from a dull, constant ache to a sudden, sharp sensation that leaves the person incapacitated. It is estimated that approximately 65 million adults in the U.S., or 25% of U.S. adults, suffer from acute back pain1 with a total potential global market opportunity of approximately $10.0 billion by 2026.

There are currently no approved non-NSAID (non-steroidal anti-inflammatory drugs) pharmaceutical treatments specifically indicated for the treatment of acute LBP. The market we intend to address with SP-103, if approved, includes etiologies that are currently treated with non-procedural or non-surgical interventions, and where available treatments provide inadequate pain relief or result in unacceptable adverse effects. These treatments may include NSAIDs, antidepressants and opioids, as well as off-label use of lidocaine patches.

The safe and effective treatment of acute LBP represents high unmet needs and creates a large market opportunity. LBP is one of the costliest benign conditions in industrialized countries. Experts have estimated that approximately 80% of Americans will experience LBP during their lifetime. The annual prevalence of LBP is 15% to 45% with a point prevalence of approximately 30% in the United States. Sixty percent of those who suffer from acute LBP recover in six weeks and up to 80-90% recover within 12 weeks2. However, the recovery of the remaining patients with LBP is less certain. LBP accounts for 19% of all workers' compensation claims in the United States. Americans spent at least $135 billion in 2016 on treating low back and neck pain, which was the highest expenditure among 154 conditions studied by the Department of the Institute for Health Metrics and Evaluation at the University of Washington.

Scilex's triple-strength SP-103 is an investigational, non-aqueous lidocaine topical system undergoing clinical development in acute LBP conditions. SP-103 builds on the learnings from ZTlido because both products share the same adhesive drug delivery formulation and manufacturing technology. If approved, we believe that SP-103 could become the first-in-class lidocaine topical product for acute LBP indications. All current uses of topical lidocaine products for acute LBP are off label. SP-103 has three times the drug load of ZTlido (108 mg versus 36 mg) in the same adhesive system to potentially deliver threefold the level of the drug within a targeted area, still with the convenience of a single topical system. Additionally, SP-103 is designed to deliver a localized dose of lidocaine that is three times greater than any lidocaine topical product that we are aware of either on the market or in development. If approved, we believe SP-103 may be able to address the limitations of prescription lidocaine patches in treating acute LBP by delivering a higher dose of lidocaine to the application site. As part of the lifecycle management, Scilex will also target localized musculoskeletal pain, acute and chronic pain conditions, and post operation pain management to focus on developing and commercializing non-opioid therapies for patients with acute and chronic pain. Scilex expects to complete this trial in one year. The outcome should enable planning of subsequent phase 3 trial(s).

Scilex Holding Company and Vickers Vantage Corp. I (NASDAQ:VCKA) ("Vickers"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbol "SCLX" and "SCLXW", respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of Vickers's shareholders and the satisfaction or waiver of certain other customary closing conditions.

A corporate presentation describing Scilex's development plans can be found at www.scilexholding.com.