• 08 Jan 2016

    NEMUS Bioscience Prodrug of THC (NB1111) Completes Validation Stage of Glaucoma Testing and Development

    COSTA MESA, CA (Accesswire, January 5, 2016) - NEMUS Bioscience, Inc. (OTCQB: NMUS) has announced the completion of the validation stage of testing of its cannabinoid-based therapy being developed for the treatment and management of glaucoma. The therapy, NB1111, is a proprietary prodrug version of tetrahydrocannabinol (THC) that has been shown to reduce intraocular pressure (IOP) in a rabbit glaucoma model. This compound has been in-licensed from our commercial and research partner, the University of Mississippi. 

    The prodrug of THC has previously been shown in University of Mississippi experiments to successfully enter multiple chambers of the eye when administered to animals by topical drop and bioerodable film. Additionally, in experiments conducted at the University of Mississippi, it has been reported that NB1111 topical drops successfully lowered IOP in the α-chymotrypsin induced rabbit glaucoma model by 45% - 50%. That study also showed that dosing of the topical drop would require more than five applications a day to insure IOP coverage. 
    Current experiments at the University examined the IOP-lowering efficacy of NB1111 when it is formulated in solid-lipid nanoparticles (SLN) and administered by topical drop in the α-chymotrypsin induced rabbit glaucoma model. Data from the SLN-based treatment arms revealed the maximum IOP lowering effect was 20% and 35% with concentrations of 0.4% and 0.6% (THC equivalent concentrations), respectively. The delivery of NB1111 using SLNs would result in two to three daily applications of topical drops. Use of NB1111 alone in a topical drop, not in an SLN formulation, resulted in a maximum reduction in IOP of 45% at a 0.6% THC equivalent concentration, validating the activity seen in earlier experiments. 
    “Blindness associated with glaucoma is the result of the death of retinal ganglion cells (RGCs). Reduction in IOP is important in mitigating the crush injury to RGCs in hypertensive types of glaucoma,” stated Brian Murphy, MD, MPH, CEO-CMO of NEMUS. “Cannabinoid molecules, like NB1111, have been shown to optimize the reduction in IOP and given historical data, cannabinoids have also been found to exert direct neuroprotective effects on the optic nerve. The company plans on pursuing an IND enabling strategy by advancing the testing of NB1111 into another specie, either canine or primate, and plans to work in parallel with the University of Mississippi, to move this effective reducer of IOP into an implantable sustained release vehicle to provide long-term IOP control, eliminating the need for daily topical drop administration. NEMUS feels that this tripartite development strategy directed towards maximizing IOP reduction with a prodrug of THC, exposing RGCs to the neuroprotective qualities of cannabinoids, coupled to a sustained release technology, best optimizes efficacy and safety in a disease requiring chronic therapy. We want this program to exceed evolving standards of care in glaucoma and that includes de-risking non-compliance associated with topical drops by delivering this medication via an implantable sustained release technology. ” 
    “We are pleased with the results of this series of experiments that again have shown that cannabinoids hold great potential to be an effective, possibly best-in-class, IOP lowering medication,” commented Dr. Mahmoud ElSohly, professor at the National Center for Natural Products Research at the university. “We look forward to also bringing forward novel forms of CBD to complement NB1111 for use as a therapy in eye disease.” 
    “Our research team plans on submitting data from this series of experiments to an upcoming scientific meeting as we look forward to sharing information on tissue concentration metrics that prodrug formulations of cannabinoids have been shown to greatly enhance,” said Dr. Soumyajit Majumdar, Associate Professor of Pharmaceutics and Drug Delivery and Associate Dean for Research in the School of Pharmacy at the university and lead scientist of the ophthalmic studies of NB1111. 
    “NEMUS is moving in a strategic direction to better elucidate the IOP lowering capability of cannabinoid prodrugs, to better understand their neuroprotective potential, and to better deliver them to maximize patient compliance and convenience,” stated Robert N. Weinreb, Chair and Distinguished Professor of Ophthalmology at the University of California, San Diego (UCSD). 
    “The company expects to move NB1111 into the next stage of animal testing in the first quarter of 2016 and looks to schedule a pre-IND meeting with the FDA in the first half of 2016. Our goal is to not only bring a cannabinoid-based medicine forward for glaucoma, but through our recent in-licensing of CBD derivatives from the University, develop an ophthalmology franchise that can address unmet medical needs in multiple chambers of the eye, including the retina,” stated Dr. Murphy. 

    The Company is a biopharmaceutical company, headquartered in Costa Mesa, California, focused on the discovery, development, and commercialization of cannabis-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 cannabis-based drugs for specific indications, with the aim of optimizing the clinical effects of such drugs, while limiting the potential adverse events. NEMUS' strategy will explore the use of natural and synthetic compounds, alone or in combination. 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 www.nemusbioscience.com 

    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, including statements about the potential benefits of cannabinoid-based medicine and the timing of further development efforts. In some cases, forward-looking statements can be identified by terminology including "goal," "focus," "aims," "believes," "can," "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, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of NEMUS’ 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.