COSTA MESA, Calif.—Nemus Bioscience Inc. has announced the signing of a research agreement with the University of Mississippi (UM) to further explore the analgesic and abuse-deterrent properties of NB2111, a unique analogue of cannabidiol (CBD). These planned in-vivo studies will serve to complement and expand upon early data that showed NB2111 provided dose-dependent analgesia comparable to opioids in animals exposed to noxious stimuli. NB2111 also exhibited anti-addictive activity against opioids in a validated animal model of abuse liability.
Dr. Brian Murphy, Nemus’ CEO and chief medical officer, noted, “The global need for effective analgesics continues to grow with aging populations and the attendant conditions associated with diseases of old age. With research indicating a global pain management market potentially growing to $83 billion by 2024 (Transparency Market Research, 2016), Nemus plans to utilize its portfolio of cannabinoid-based therapies to develop a continuum of care for patients experiencing acute or chronic pain, as well as helping patients who may have developed a [dependence on] opioids convert to cannabinoid-class compounds that we believe offer analgesic coverage without the associated serious adverse safety profile associated with long-term opioid use.”
According to Murphy, co-founder of Nemus, Cos Lykos, who currently serves as executive chairman of the board of directors, first approached UM. “UM has held the only contract to cultivate cannabis for research purposes on behalf of the federal government since 1968,” Murphy says. “By virtue of UM’s 49-year experience with the Cannabis plant, Nemus benefits tremendously from the University’s knowledge. Nemus is the sole developmental and commercialization partner with the University and has exclusive, global licenses to intellectual property related to these molecules. The group at Nemus works closely with the University, especially related to planning studies, expanding potential indications and associated intellectual property, and even serving as adjunctive faculty.”
When asked about NB2111 and how it works, Murphy replies, “NB2111 is an analogue of the cannabinoid molecule, cannabidiol or CBD. Unlike tetrahydrocannabinol (THC), CBD is not associated with psychogenic activity. While THC has been shown to bind to cannabinoid receptors in the body, CBD does not possess as strong an intrinsic receptor affinity by comparison. Despite the disparity in receptor binding affinity between the molecules, CBD has been associated with activities related to cannabinoid receptor type 2 (CB-2) consisting of anti-inflammation, neuroprotection and immunomodulation.”
“NB2111 is early in development, but in animal studies it has been found to penetrate multiple major organ systems as well as traversing the blood-brain barrier to enter the central nervous system,” Murphy continues. “The molecule has exhibited some degree of preferential sequestration in the liver when compared to concentrations in other organs that could possibly be leveraged for therapies related to fibrosis of the liver. More study is needed related to the possible utility of the molecule in fibrotic diseases. NB2111 has also been studied in murine models of tactile allodynia, and was shown to provide analgesia comparable to morphine as well as anti-addictive activity when compared to opioids. Nemus intends to expand the developmental track into an industrial synthesis scale-up capability and move to formulation options after synthesis methods have been validated.”
“According to the Centers for Disease Control, an average of 78 opioid-related overdose deaths occur each day in the United States,” commented Dr. Kenneth J. Sufka, professor of psychology and pharmacology and a research professor with the National Center for Natural Products Research at UM. “We feel having a safer yet effective alternative is vital to both national and global health. We believe these compounds will have utility in managing a spectrum of pain conditions, from the quality-of-life debilitating pain associated with fibromyalgia to intense post-surgical pain. Our team looks forward to working with Nemus to explore a variety of treatment options in anticipation of future human studies.”
“The company is happy to work with Prof. Sufka, a recipient of the 2014 CASE-Carnegie Award as one of the preeminent educator-researchers in the country,” stated Murphy. “We expect to formally present this data at an upcoming peer-reviewed scientific meeting. Nemus plans to examine developmental partnering opportunities with companies who may already have a presence in this therapeutic area but are looking to expand their portfolio into cannabinoids and/or companies developing novel delivery systems, especially those that permit bypassing first-pass metabolism in the liver.”
Murphy tells DDNews, “Future studies of NB2111 could include a dose-escalation study in an animal model of chemotherapy-induced peripheral neuropathy (CIPN), as well as using a validated animal model place-preference study to further assess the anti-addictive potential of the molecule. Nemus is also planning to conduct a study assessing the analgesic potential of NB2111 in a validated animal model of migraine. The company is contemplating study options to assess the therapeutic potential of NB2111 in in-vitro studies of fibrotic diseases.”
“Dosing CBD can pose a challenge as native cannabinoid molecules are hydrophobic and do not readily cross membranes effectively except in the instance of smoking marijuana,” Murphy says. “Nemus is a cannabinoid-incubator working to disrupt this therapeutic space by introducing and developing re-engineered cannabinoid molecules that enhance bioavailability and the predictability of pharmacokinetics associated with these proprietary molecules. The molecules are designed to be more hydrophilic and therefore can be potentially repurposed for multiple therapeutic indications based on routes of administration that could optimize safety and efficacy. In addition to patents, Nemus has also licensed associated routes of administration including ocular, buccal (absorption across the gingiva), nasal and trans-membranous including rectal and vaginal suppositories.”
Murphy continues, “In the near term, Nemus is evaluating the potential use of NB2111 for CIPN and as a possible alternative anti-addiction therapeutic option. Longer term, we believe there may be potential uses of NB2111 related to diseases of the central nervous system like epilepsy, multiple sclerosis and Parkinson’s disease, as well as anti-inflammatory options. In addition, we feel this analogue of CBD, when formulated for ocular use (NB2222), might play a role in mitigating diseases of the eye such as uveitis, macular degeneration and diabetic retinopathy.”
“As a cannabinoid incubator, Nemus looks to achieve partnering options for these therapeutic candidates. We believe partnering could potentially permit the Company to establish a milestone/royalty revenue stream so other cannabinoid-based therapies could be advanced into preclinical or early-stage clinical testing,” Murphy concludes.
Teewinot boasts ability to produce commercial quantities of cannabinoids
TAMPA, Fla.—Teewinot Life Sciences Corp., a global leader in the use of biosynthetic processes for the production of kilogram quantities of pharmaceutical-grade cannabinoids, has announced its wholly owned subsidiary, Full Spectrum Laboratories Ltd. (FSL), can produce commercial quantities of THCVA, CBDVA, CBCVA and CBGVA (varin series) using its proprietary CannSynthesis technology.
Dr. Richard Peet, executive vice president of Teewinot and co-inventor of the CannSynthesis technology, stated, “Our proprietary CannSynthesis process makes possible the cost-effective production of commercial quantities of pharmaceutically pure cannabinoids that are produced in relatively small quantities by the Cannabis plant. Using FSL’s revolutionary biosynthetic process, it’s now possible to envision treating patients with cannabinoids that are impractical to cost-effectively produce in commercial quantities by plant extraction or chemical synthesis.”
It’s not practical to commercially produce the varin series compounds by means of plant extraction because the Cannabis plant only produces small quantities of these cannabinoids. FSL has developed patent-protected biosynthetic processes for the manufacture of THCVA, CBDVA, CBCDA and CBGVA using enzymes such as THCA synthase and CBDA synthase.
Jeffrey M. Korentur, Teewinot’s president and CEO, says, “It’s hard to overstate the significance that this expansion of our manufacturing catalog provides. Researchers around the world are demanding better access to this important and demonstrably effective sub-set of cannabinoids, and Teewinot is excited to be the market leader in this space. Until now, there has been no commercially reliable method of producing these molecules. The CannSynthesis process ensures global availability of the varin series at a reasonable cost, and with a supply chain that can effortlessly scale to meet the demands of the market. CannSynthesis eliminates the risks associated with agricultural and chemical production methods, yet provides the purest cannabinoids to the research, medical and pharmaceutical communities.”