Abstract P109: A Promising Novel Hypertension Drug Candidate

This study tests the hypothesis that 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. A Phase 1 / 2 study tested 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. Forty-one hypertensive people were screened, twenty-two qualified to be enrolled and twenty-one completed the 10 day inpatient trial. In the study, after a 7 day washout period, participants were admitted and had a 3 day run in on only placebo followed by a 7 day double blind treatment period. Fifteen people received active treatment with 440 mg of elemental Mg BID (a total of 880 mg daily) and six received placebo. Data collected include daily seated blood pressure as well as 24h ambulatory blood pressure (ABPM) measurements. In addition, ECG, routine laboratory tests including serum Mg levels and 24h urinary Mg excretion were performed on days 3 and 10.ABPM 24h mean blood pressure changes day, night and 24° are as follows: SBP day :-6.2, DBP day :-2.3, SBP night :-4.9 , DBP night :-1.3 , SBP 24° :-6.6 , DBP 24° :-2.8 , SBP+DBP 24° :-9.4. One individual was excluded because her SBP decreased from 155 to 108 mm Hg after five days on protocol, below the 110 mm SBP protocol exclusion criteria. No symptoms of hypotension were observed. A correlation was noted between 24h levels of urinary Mg excretion and the 24h ABPM BP reduction. There were no adverse effects in the study group. A trend correlating serum Mg levels increase and BP decrease across the study population was noted. 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.