Nemus Bioscience Announces Presentation of NB1111 Impact on Intraocular Pressure (IOP) in Normotensive Ocular Model at the National Meeting of the American Association of Pharmaceutical Scientists (AAPS)

COSTA MESA, CA / ACCESSWIRE / November 15, 2016 / NEMUS Bioscience, Inc. (OTCQB: NMUS) announced that significant data concerning the IOP lowering effect of NB1111 and duration of action will be presented at the 2016 AAPS National Meeting being held in Denver, Colorado on Wednesday, November 16, 2016, at 8:30 a.m. (MST) by the company’s research and commercialization partner, the University of Mississippi.

The abstract, “Effect of single versus multiple day regimen of Δ9 -THC-valine-hemisuccinate (THCVHS) on the intra-ocular pressure (IOP) lowering activity in normotensive rabbits” (abstract # 30W0830), reports data comparing the Nemus prodrug of tetrahydrocannabinol (THCVHS) also known as NB1111, to established glaucoma therapies of Pilocarpine and Timolol, as well as standard Δ9 -THC in both emulsion and solid lipid nanoparticle (SLN) eye drops. All studies were conducted in a normal, non-glaucomatous eye. A link to the abstract on the AAPS website can be found at https://annual.aapsmeeting.org/poster/member/66948.

The goals of the studies were to examine penetration and concentration of NB1111 in ocular tissues responsible for IOP regulation and to correlate that concentration to measurement of IOP. Additionally, the studies examined the effect on drug half-life by encapsulating NB1111 in a SLN with single- and multiple-day dosing for up to five days.

The data revealed:

NB1111 lowered IOP in a normal eye in a statistically significant manner with peak IOP decline of 32% versus 16% for Pilocarpine and 23% for Timolol (p< 0.05); prior experiments in a glaucomatous eye exhibited a 45% IOP reduction for NB1111
The experiments demonstrated that increased drug concentration of NB1111 in the ciliary body and retina/choroid plexus was correlated with a decline in IOP; these ocular organs help regulate IOP
Use of Δ9 – THC (parent molecule, non-prodrug), whether formulated in an emulsion or SLN eye drop solution, resulted in no significant tissue concentration nor decline in IOP
Formulation of NB1111 into an SLN produced a duration of activity that could be consistent with twice daily eye drop dosing in humans and successfully transported the drug into both the anterior and posterior compartments of the eye and was highly significant compared to both approved comparator drugs (p<0.001)
No safety issues were noted with the administration of NB1111 over five days dosing
No free THC was detected in the peripheral circulation of the test animals after repeated dosing NB1111 using an assay with nanogram detection sensitivity

“These findings are critical to our understanding on how this novel prodrug of THC can reduce IOP so effectively,” stated Soumyajit Majumdar, PhD, 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. “As important as the ocular findings were in these studies, we were also pleased to see that the plasma THC levels in these animals, even those undergoing repeated ocular dosing, did not have detectable levels of THC. This is a key safety finding for this drug.”

Dr. Mahmoud ElSohly, professor at the National Center for Natural Products Research at the University of Mississippi, commented: “Multiple experiments, including previously reported data, have clearly demonstrated a causal relationship between the drug’s tissue concentration and IOP lowering in both normal and glaucomatous eyes. This unique prodrug technology has enhanced treatment concentrations in the eye and could signal a new therapeutic class for the management of glaucoma.”

“NB1111 has performed above expectations in the ability to lower IOP in these animal models. We want to further explore the neuroprotective effects of cannabinoids upon the optic nerve and move the ophthalmology program into human testing. I am also happy to report that our colleagues at the University of Mississippi have been able to develop an early ocular formulation of our CBD analogue, and in doing so, expands our ocular program into a full-fledged ophthalmology platform that could address multiple eye diseases beyond glaucoma, including diseases of the retina,” noted Brian Murphy, MD, MBA, Nemus CEO and Chief Medical Officer.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements, including statements about the potential benefits of NB1111 and 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,” “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, 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 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 http://www.nemusbioscience.com.

CONTACTS:

NEMUS Investor Relations
PCG Advisory Group
Adam Holdsworth
Email: adamh@pcgadvisory.com
Phone: 646-862-4607

NEMUS Media Relations
Janet Vasquez
JV Public Relations
Email: jvasquez@jvprny.com
Phone: 212.645.5498

SOURCE: NEMUS Bioscience, Inc.

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