Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly owned subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, and Denali Capital Acquisition Corp., a Cayman Islands corporation and special purpose acquisition company (Nasdaq: DECA, “SPAC”), announced the signing of a letter of intent for a proposed business combination, which provides for a pre-transaction equity value of Semnur up to $2.0 billion , subject to adjustment based on third-party fairness opinion, with expected gross proceeds of up to $40 million depending on the number of SPAC shares that are redeemed prior to the completion of the business combination.
About SP-102
SP-102 has the potential to be the first non-opioid epidural product approved to treat a common condition, lumbosacral radicular pain, which could be an important alternative to compounded and off-label used steroids.
60 percent of the chronic pain market is made up of opioid prescriptions*
Opioid prescriptions account for up to 60 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.*
Use of the opioids and other drugs associated with safety risks and addictive potential. Opioids are commonly used for lumbosacral radicular pain and if taken with benzodiazepines can be extremely dangerous and possible lead to overdose/death. Reducing reliance on narcotics and providing alternative FDA approved treatment may address an important public safety concern and contribute to reduction of opioid use.
There are currently no steroids approved for epidural use, and compounded steroid preparations have been associated with outbreaks of fungal meningitis, sometimes with fatal outcomes. Other medications sometimes used for epidural injections (e.g.: local anesthetics) do not treat the underlying inflammation.
* Opioids for Back Pain Patients – Primary Care Prescribing Patterns and Use of Services (National Institutes of Health 2011)
About the Study
The CLEAR Clinical Research Study is currently being conducted at sites throughout the U.S. The purpose of the Study is to evaluate SP-102 for the relief of sciatica. SP-102 is a novel, non-opioid injectable gel formulation intended for the treatment of lumbar radicular pain, commonly known as sciatica.
What is the purpose of the CLEAR Clinical Research Study?
- To compare the pain relief following a single injection of SP-102 to a placebo (a product that has no therapeutic effect)
- To evaluate the level of pain relief
- To evaluate the ability to physically do or not do things
- To evaluate the safety of the SP-102 injection
As part of the CLEAR Clinical Research Study, patients will be randomly assigned (by computer) to the treatment group or the placebo group. If selected for the placebo group, there is an opportunity to receive a single injection of SP-102 and follow up evaluation later in the study. If a patient is qualified and chosen to join the CLEAR Clinical Research Study, all study-related care is provided at no cost to the patient.
About the Treatment
SP-102 is a non-opioid injectable gel intended for the treatment of lumbosacral radicular pain, the most common type being sciatica.
SP-102 has an ingredient which is a widely used corticosteroid solution. Corticosteroids have been given epidurally (directly into the spine) for the pain caused by sciatica since about 1970; however, there is no US FDA-approved injectable corticosteroid for sciatica.
SP-102 is a treatment intended to produce an anti‑inflammatory effect from the widely used corticosteroid solution and it is intended to last longer than other steroid injections possibly used by your doctor to treat your sciatica. SP-102 contains no particulates and no neurotoxic preservatives, which is expected to result in a better safety profile.
26 percent of the U.S. population (20 yrs+) are affected by chronic pain*
SP-102 is not able to be sold as a drug yet in the US as it has not been approved for marketing by the Food and Drug Administration (FDA) or in any other country. This study is for research purposes only and it is required if SP-102 is to be approved by the regulatory agencies (like the FDA) around the world to be legally sold as a drug.
SP-102 injectable gel has been given to a few research participants epidurally for the treatment of sciatica. These participants tolerated it well and had very few side effects.
* Opioids for Back Pain Patients – Primary Care Prescribing Patterns and Use of Services (National Institutes of Health 2011)