NEMUS Bioscience Reports Favorable Bio-Distribution And Anti-Addictive Findings Versus Plant-Derived Cannabidiol (CBD) In Animal Model Studies Of NB2111, An Analogue Of Cannabidiol
Costa Mesa, Calif. (February 13, 2017) - NEMUS Bioscience, Inc. (OTCQB: NMUS) announced that the company and its research and development partner, the University of Mississippi School of Pharmacy (UM), have conducted in vitro and in vivo bio-distribution and anti-addictive studies of NB2111, a unique analogue of cannabidiol (CBD). In the studies, NB2111 exhibited molecular stability in both gastric and intestinal pH modeling and did not convert to tetrahydrocannabinol (THC). We believe this is an important advantage over plant-derived CBD, which in these studies, partially converted to THC, the cannabinoid with psychoactive properties. Additionally, NB2111 exhibited an ability to penetrate all major organ systems, including the brain. Of note, the molecule showed a predilection for liver tissues that we believe might be exploited for the treatment of liver diseases responsive to cannabinoids. Lastly, NB2111 showed a statistically significant ability to mitigate opioid addiction in a validated animal model of addiction versus plant-derived CBD. This data complements the company’s previously reported analgesic data related to NB2111 providing analgesia comparable to morphine.
“Though early in development, NB2111 continues to provide encouraging data related to both CNS activity such as analgesia potential, and systemic circulatory attributes such as liver sequestration. We believe NB2111 might offer diverse opportunities in therapeutic potential based on organ penetration, route of administration, and physiological activity in response to this cannabinoid,” commented Brian Murphy, M.D., M.B.A., Nemus CEO and Chief Medical Officer. “In this regard, the stability of the molecule across a spectrum of pH conditions was an important finding as we look to formulation possibilities, including oral dosing as the molecule was not found to convert to THC. We expect to advance this work into living systems for validation and if successful, might open other potential indications affecting the gastrointestinal tract and accessory organs.”
Key findings from these studies include:
• An in vitro assay studying the effect of pH on molecular stability revealed that plant-derived CBD partially converted to ?9 – THC when exposed to acidic gastric conditions whereas NB2111 remained stable in pH conditions seen in both the stomach (pH = 1.2) and intestine (pH = 7.2) and did not convert to ?9 – THC
• Within thirty minutes of dosing in an animal cohort, via suppository or intra-peritoneal injection, NB2111 was detected in all major organ systems in a dose-proportional manner; assays at four hours post-dosing continued to show NB2111 in all major organ systems; plasma levels of NB2111 persisted for more than four hours
• NB2111 crossed the blood-brain barrier in a dose-proportional manner and was detected in the central nervous system (CNS) up to four-hours after dosing
• NB2111 exhibited preferential sequestration in the liver when compared to other organ systems; hepatic concentrations were up to 15x higher than other major organs; similarly dosed plant-derived CBD preparations did not display this preferential hepatic sequestration activity
• In a murine place-preference model assessing the attenuation of addictive behavior related to morphine dosing, NB2111 significantly blocked the addictive effects of morphine (p = 0.005) while plant-derived CBD exhibited only a statistical tendency to block these addictive effects (p = 0.051)
Dr. Mahmoud ElSohly, professor at the National Center for Natural Products Research at the University of Mississippi School of Pharmacy and co-inventor of NB2111 noted, “The work of my colleagues, Dr. (Kenneth) Sufka, who is studying the analgesic and anti-addictive properties of NB2111, and Dr. (Soumyajit) Majumdar, who is working to advance this molecule to potentially treat multiple eye diseases, highlights the possible influence of cannabinoid molecules to impact health. I find the liver sequestration activity of NB2111 particularly interesting since it has been demonstrated that CBD might help prevent or slow liver fibrosis by inducing liver stellate cell death or apoptosis. Given the global epidemics of cirrhosis seen with fibrotic diseases of the liver like non-alcoholic steatohepatitis (N.A.S.H.), our lab looks to pursue further research in the area of inflammation and tissue fibrosis leading to scarring.”
“Nemus now has two major cannabinoid-based therapeutic platforms: one centered on a prodrug of THC and the other an analogue of CBD. These candidate molecules help position Nemus in seeking partnering opportunities to advance formulations developed for the treatment of glaucoma (NB1111), chemotherapy-induced nausea and vomiting (CINV; NB1222), chemotherapy-induced peripheral neuropathy (CIPN; NB2111) and anti-infectives directed against bacteria and viruses,” said Dr. Murphy. “Should partnering be successful, the company will then address follow-on indications for these molecules, such as diseases of the retina and anti-fibrotic activity.”
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements about the studies relating to and the potential benefits of NB1111, NB1222, NB2111 as well as the timing of our near term, intermediate term and long term goals. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including "goal," "focus," "aims," “expects,” “plans,” "believes," "can," “could,” "challenge," "predictable," "will," or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of NEMUS’s most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, NEMUS disclaims any intent or obligation to update these forward-looking statements.
ABOUT NEMUS BIOSCIENCE, INC.
The Company is a biopharmaceutical company, headquartered in Costa Mesa, California, focused on the discovery, development, and commercialization of cannabinoid-based therapeutics for significant unmet medical needs in global markets. Utilizing certain proprietary technology licensed from the University of Mississippi, NEMUS is working to develop novel ways to deliver cannabinoid-based drugs for specific indications, with the aim of optimizing the clinical effects of such drugs, while limiting potential adverse events. NEMUS's strategy is to explore the use of natural and synthetic compounds, alone or in combination with partners. The Company is led by a highly qualified team of executives with decades of biopharmaceutical experience and significant background in early-stage drug development.
For more information, visit http://www.nemusbioscience.com.
About the University of Mississippi
The University of Mississippi, the state's flagship institution, is among the elite group of R-1: Doctoral Universities - Highest Research Activity in the Carnegie Classification. The university has a long history of producing leaders in public service, academics, research and business. Its 15 academic divisions include a major medical school, nationally recognized schools of accountancy, law and pharmacy, and an Honors College acclaimed for a blend of academic rigor, experiential learning and opportunities for community action.
“Though early in development, NB2111 continues to provide encouraging data related to both CNS activity such as analgesia potential, and systemic circulatory attributes such as liver sequestration. We believe NB2111 might offer diverse opportunities in therapeutic potential based on organ penetration, route of administration, and physiological activity in response to this cannabinoid,” commented Brian Murphy, M.D., M.B.A., Nemus CEO and Chief Medical Officer. “In this regard, the stability of the molecule across a spectrum of pH conditions was an important finding as we look to formulation possibilities, including oral dosing as the molecule was not found to convert to THC. We expect to advance this work into living systems for validation and if successful, might open other potential indications affecting the gastrointestinal tract and accessory organs.”
Key findings from these studies include:
• An in vitro assay studying the effect of pH on molecular stability revealed that plant-derived CBD partially converted to ?9 – THC when exposed to acidic gastric conditions whereas NB2111 remained stable in pH conditions seen in both the stomach (pH = 1.2) and intestine (pH = 7.2) and did not convert to ?9 – THC
• Within thirty minutes of dosing in an animal cohort, via suppository or intra-peritoneal injection, NB2111 was detected in all major organ systems in a dose-proportional manner; assays at four hours post-dosing continued to show NB2111 in all major organ systems; plasma levels of NB2111 persisted for more than four hours
• NB2111 crossed the blood-brain barrier in a dose-proportional manner and was detected in the central nervous system (CNS) up to four-hours after dosing
• NB2111 exhibited preferential sequestration in the liver when compared to other organ systems; hepatic concentrations were up to 15x higher than other major organs; similarly dosed plant-derived CBD preparations did not display this preferential hepatic sequestration activity
• In a murine place-preference model assessing the attenuation of addictive behavior related to morphine dosing, NB2111 significantly blocked the addictive effects of morphine (p = 0.005) while plant-derived CBD exhibited only a statistical tendency to block these addictive effects (p = 0.051)
Dr. Mahmoud ElSohly, professor at the National Center for Natural Products Research at the University of Mississippi School of Pharmacy and co-inventor of NB2111 noted, “The work of my colleagues, Dr. (Kenneth) Sufka, who is studying the analgesic and anti-addictive properties of NB2111, and Dr. (Soumyajit) Majumdar, who is working to advance this molecule to potentially treat multiple eye diseases, highlights the possible influence of cannabinoid molecules to impact health. I find the liver sequestration activity of NB2111 particularly interesting since it has been demonstrated that CBD might help prevent or slow liver fibrosis by inducing liver stellate cell death or apoptosis. Given the global epidemics of cirrhosis seen with fibrotic diseases of the liver like non-alcoholic steatohepatitis (N.A.S.H.), our lab looks to pursue further research in the area of inflammation and tissue fibrosis leading to scarring.”
“Nemus now has two major cannabinoid-based therapeutic platforms: one centered on a prodrug of THC and the other an analogue of CBD. These candidate molecules help position Nemus in seeking partnering opportunities to advance formulations developed for the treatment of glaucoma (NB1111), chemotherapy-induced nausea and vomiting (CINV; NB1222), chemotherapy-induced peripheral neuropathy (CIPN; NB2111) and anti-infectives directed against bacteria and viruses,” said Dr. Murphy. “Should partnering be successful, the company will then address follow-on indications for these molecules, such as diseases of the retina and anti-fibrotic activity.”
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements about the studies relating to and the potential benefits of NB1111, NB1222, NB2111 as well as the timing of our near term, intermediate term and long term goals. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including "goal," "focus," "aims," “expects,” “plans,” "believes," "can," “could,” "challenge," "predictable," "will," or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of NEMUS’s most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, NEMUS disclaims any intent or obligation to update these forward-looking statements.
ABOUT NEMUS BIOSCIENCE, INC.
The Company is a biopharmaceutical company, headquartered in Costa Mesa, California, focused on the discovery, development, and commercialization of cannabinoid-based therapeutics for significant unmet medical needs in global markets. Utilizing certain proprietary technology licensed from the University of Mississippi, NEMUS is working to develop novel ways to deliver cannabinoid-based drugs for specific indications, with the aim of optimizing the clinical effects of such drugs, while limiting potential adverse events. NEMUS's strategy is to explore the use of natural and synthetic compounds, alone or in combination with partners. The Company is led by a highly qualified team of executives with decades of biopharmaceutical experience and significant background in early-stage drug development.
For more information, visit http://www.nemusbioscience.com.
About the University of Mississippi
The University of Mississippi, the state's flagship institution, is among the elite group of R-1: Doctoral Universities - Highest Research Activity in the Carnegie Classification. The university has a long history of producing leaders in public service, academics, research and business. Its 15 academic divisions include a major medical school, nationally recognized schools of accountancy, law and pharmacy, and an Honors College acclaimed for a blend of academic rigor, experiential learning and opportunities for community action.