Bullish options flow was detected in SRNE stock on October 8, 2020.
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The problem with SRNE stock is that it seems like the company is always announcing incredible COVID-19 products but they leave you scratching your head and wondering if it was just sensational marketing because the stock doesn’t really move too much on these press releases now.
On October 7, 2020, Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced that it has discovered a small molecule termed Salicyn-30 that demonstrated a potent 3-4 log reduction of SARS-CoV-2 virus infection in an in vitro virus infection experiment.
Since the beginning of the COVID-19 pandemic, Sorrento has developed a program targeting the entire continuum of care (for prevention, early treatment and rescue therapies) to manage COVID-19 disease. It is Sorrento’s belief that multi-modal therapies will naturally follow the approval of effective single therapies, regardless of individual drug potential.
Using a drug repurposing strategy, Sorrento has been looking for compounds that could synergistically supplement its current antibody program and, in that process, screened a collection of salicylanilide compounds of interest from a library of molecules developed upon a chemical scaffolding known as salicylanilides. In preliminary preclinical experiments, comparative data generated thus far demonstrates Salicyn-30 may be more effective than another salicylanilide, niclosamide, a small molecule previously used to treat tapeworm infection, which has recently entered clinical trials (NCT04372082) to examine its effectiveness against COVID-19.
Drug repurposing for other diseases has gained widespread attention in recent years as several such drugs have been approved by the FDA. Moreover, in the global emergency of the COVID-19 pandemic, this is one of the strategies being implemented by both major pharma and academic efforts.
Sorrento’s intent on examining a salicylanilide library as a starting point for targeting COVID-19 (and potentially other coronaviruses) is grounded upon the concept that drug repurposing, is generally cost and time effective, with the potential for high returns and relatively low risk. Sorrento’s unique approach goes beyond identifying an anti-viral drug through repurposed molecule screening and is aimed at finding an optimal small molecule candidate that could be further developed for its potential to enhance the proprietary pipeline of clinical stage neutralizing antibodies.
Salicyn-30 will be developed initially as a stand-alone therapy to potentially reduce viral load in severely affected patients. In parallel, its potential in combination with Sorrento’s antibodies currently in development will be validated, both for synergistic efficacy but also to ensure that the safety of the combination therapy is established prior to human trials.
Dr. Henry Ji, Sorrento’s Chairman and CEO, stated, “Salicyn-30 has shown exceptional therapeutic potential, it is orally available and has greater systemic exposure besides being more potent than other salicylanilide niclosamides in preclinical trials to date. We see high potential value for this new small molecule inhibitor of SARS-CoV-2 either as a standalone therapeutic or used in conjunction with the proprietary neutralizing antibodies (nAbs) STI-1499 and affinity matured STI-2020 being developed by our Company. Our ultimate goal is to be able to provide patients with solutions at each stage of the COVID-19 disease continuum and ensure all the therapeutic solutions we put forward work well together and enhance each other.”
Also on October 7, 2020, Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), announced continuous sales growth in ZTlido® from quarter to quarter in 2020. Scilex expects third quarter 2020 ZTlido® net sales to grow 26% to approximately $7.2MM, compared to $5.7MM in Q2-2020. The preliminary third quarter 2020 net sales information presented in this press release is based on Scilex’s current expectations and may be adjusted as a result of, among other things, completion of customary quarterly review procedures.
Scilex’s SP-102 (SEMDEXA™) is currently being evaluated in a pivotal Phase 3 clinical trial in the U.S. to evaluate patients with lumbosacral radicular pain/sciatica. The trial is expected to complete enrollment in the fourth quarter of 2020 and top-line data is expected in the second quarter of 2021. Scilex intends to use the results from this pivotal Phase 3 trial to discuss with U.S. health authorities the basis for licensure application to the U.S. Food and Drug Administration (FDA) for this high unmet need indication where no treatments have been approved and which is responsible for millions of people suffering in the U.S. alone. Scilex has extensive clinical and pre-clinical data (including multiple Phase 2 clinical trials) with the novel viscous formulation of SP-102, which was designed to provide extended local effect for sciatica patients. The robust data collected over the course of the company’s multi-year clinical development program will be presented to the U.S. FDA as part of a new drug application.
The CLEAR (“Corticosteroid Lumbar Epidural Analgesia for Radiculopathy”) clinical study is a randomized, double-blind, placebo-controlled Phase 3 trial that is expected to enroll 400 patients with lumbosacral radicular pain at 40+ sites across the U.S. The primary endpoint of the study is mean change in the Numeric Pain Rating Scale (NPRS) for leg pain with SP-102 epidural injection compared to intramuscular injection of placebo over four weeks. The secondary endpoints include other measures of pain at 4 and 12 weeks as well as time to repeat injection of SP-102, safety and function. The study includes an open-label extension to build the safety database of patients treated with SP-102. “We are anxiously awaiting a new injectable formulation of dexamethasone and registration for treatment of radicular pain based on results of a large, randomized placebo-controlled multi-center trial. If approved by the FDA, SP-102 would be the first corticosteroid for epidural injections addressing safety issues with steroid medications, currently used off-label, and an important addition to armamentarium of interventional pain physicians,” said Dr. Steve Cohen, Chief of Pain Medicine and Professor of Anesthesiology & Critical Care Medicine, Neurology and Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, and Professor of Anesthesiology and Physical Medicine & Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences.
SP-102 is a novel, non-opioid injectable viscous gel formulation in development for the treatment of lumbosacral radicular pain, containing no neurotoxic preservatives, surfactants, solvents or particulates. The SP-102 formulation is administered by epidural injection. Based on preclinical and clinical studies conducted to date, it extends the residency time at the site of injection and has not demonstrated the safety concerns that led the FDA to issue a class warning on the currently off-label use of injectable corticosteroids to include information about the risk of serious neurologic events with epidural steroid injections (ESIs).
“Lumbosacral radicular pain, otherwise known as sciatica, is commonly treated by off-label epidural steroid injections. There are an estimated ten to eleven million epidural steroid injections administered per year in the U.S. alone and there are no approved steroids for epidural injections.2 The clinical results for the pivotal Phase 3 trial for SP-102 will be a seminal milestone for Scilex and may provide encouraging news for the many millions of people who are confronting debilitating radicular pain/sciatica. We believe that SP-102 could be the first FDA-approved epidural steroid product for patients suffering from this common, painful condition,” said Jaisim Shah, President and Chief Executive Officer of Scilex.
In 2019, the overall estimated number of ESI procedures in the U.S. was 11.6 million across all Medicare and private coverage patients, with lumbar radiculopathy / sciatica procedures comprising approximately 88% of all ESIs administered. Despite widespread utilization of ESIs, concerns persist in the market about particulate steroids and potential side effect and safety concerns (e.g., stroke) from current off-label use. As a result, a significant unmet medical need exists within the market for a potent, non-particulate ESI formulation that demonstrated safety and effectiveness in controlled clinical trial evaluations.
In the U.S., more than 30 million people live with low back and radicular pain, with this population expected to grow as the population ages. Many patients experience moderate to severe pain with intolerance and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs). There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids. Opioid prescriptions account for about 40 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.