HYPOTHESIS

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Study tests if RMJH-111B, a novel drug candidate, can improve blood pressure (BP) in hypertensive adults without the gastrointestinal distress that is often experienced with oral magnesium (Mg) treatment.

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RMJH-111B: �A NOVEL DRUG CANDIDATE TO IMPROVE HYPERTENSION

Daily Ingestion vs. Need

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GROWING MG NEED: DIET INSUFFICIENT & CELL LEVEL DECLINING; SAFETY, & EFFICACY FROM RMJH-111B

Mg multi-tasks in life…

Nature’s calcium channel blocker;�Required to activate many enzymes;�Protective of essential fats in transit;�Needed to activate ATP for cell energy;�Needed for mitochondrial proton gradient.

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Less today in soil/diet �(US & Global) �

60-70+% US & Brazil confirmed inadequate daily intake of Mg results in chronic latent magnesium deficiency, being in lower half of serum Mg lab test range (CLMD).

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DRI (adults): 310-400 mg/d may be too low

• Piovesan D et al, BMC Bioinformatics, 2012; 13(S14): S10�Sales et al. Nutricion Hospitalaria, 2014; 30(1): 200-204�Nielsen FH. Nutrition Rev, 2010; 68: 333-340
• Elin RJ, Re-evaluation of the concept of chronic, latent, magnesium deficiency (CLMD). Magnes Res. 2011 Dec;24(4):225-227. doi: 10.1684/mrh.2011.0298

STUDY DESIGN

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Phase 1 / 2 study to assess the clinical tolerability, safety and efficacy, as well as pharmacokinetics of RMJH-111B softgels.

Each softgel contains 110 mg elemental Mg as inverted micellar nanodroplets designed to enhance intestinal uptake and cell delivery of active constituents.

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METHODS AND MATERIALS

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• Hypertensive people were screened (n= 41).
• Qualified subjects enrolled (n= 22).
• 10-day inpatient trial completed (n=21).
• After a 7-day washout period, participants were admitted to a 3-day run-in on placebo, followed by a 7 day double blind treatment. �

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METHODS AND MATERIALS

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• Active treatment (n=16) with 440 mg of elemental Mg BID (a total of 880 mg daily) + and placebo (n=6).
• Data collected included:

- Daily seated blood pressure

- 24h ambulatory blood pressure (ABPM) measurements.

- ECG

- Routine laboratory tests including serum Mg levels and 24h urinary Mg excretion performed on days 3 and 10.

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RESULTS

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ABPM 24h Mean Blood Pressure changes Day, Night and 24º

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A protocol exclusion occurred because her SBP decreased from 155 to 108 mm Hg after 5 days on protocol, <110 mm Hg SBP protocol exclusion criteria.

Legend :

SBP- Systolic Blood Pressure

DBP- Diastolic Blood Pressure

RESULTS & OBSERVATIONS

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• No hypotension observed.
• Correlation noted between 24h urine Mg excretion and 24h ABPM BP reduction.
• No adverse effects in study group. Trend correlating serum Mg levels increase and BP decrease across the study population noted.

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CONCLUSIONS

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• Based on retroactive statistical analysis of data presented, if 100 people had been studied using the same protocol, a statistical significance with a P value of <0.05 would have been achieved

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• Serum Mg may predict need for, and clinical value of RMJH-111B

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PRESENTER DISCLOSURE INFORMATION ELEMENTS

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Russell Jaffe MD, PhD

Fellow, Health Studies Collegium

FINANCIAL DISCLOSURE:

• CEO, RMJ Holdings, ELISA/ACT® Biotechnologies, and PERQUE Integrative Health™
• Lab Director, ELISA/ACT® Biotechnologies

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UNLABELED/UNAPPROVED USES DISCLOSURE:

[None]

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