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

Accesswire AccesswireJanuary 5, 2016
COSTA MESA, CA / ACCESSWIRE / January 5, 2016 / NEMUS Bioscience, Inc. (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 a-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 a-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).https://finance.yahoo.com/news/nemus-bioscience-prodrug-thc-nb1111-133000054.html (also) http://www.marketwired.com/press-release/nemus-bioscience-announces-enhanced-ocular-tissue-concentration-proprietary-prodrug-otcqb-nmus-2134886.htm