RMJ Holdings Magnesium-based Drug Candidate RMJH-111B Data Presented at the American Heart Association's Hypertension 2021 Scientific Sessions

28 Sep 2021
www.biospace.com
First in ClassAHA
VIENNA, Va., Sept. 28, 2021 /PRNewswire/ -- RMJ Holdings, LLC (RMJH), today announced that data on its first drug candidate RMJH-111B, a novel drug candidate for essential hypertension, is being presented in a poster at the American Heart Association's Hypertension 2021 Scientific Sessions. Poster Presentation: A Promising Novel Hypertension Drug Candidate Presentation/Board Number: P109 Control Number: 418 Assigned Session/Topic Area: P02 Antihypertensive Drugs and Pharmacology Link: RMJH - AHA HTN Poster 2021 Author Block: Haralambos Gavras, Boston Univ Med Ctr, Boston, MA; Joel Neutel, Orange County Res Ctr, Tustin, CA; Ronald J Elin, Univ of Louisville Sch of Med, Louisville, KY; Andrea Rosanoff, Ctr for Magnesium Education and Res, Pahoa, HI; Rebecca B Costello, Ctr for Magnesium Education and Res, Pahoa, HI, Leesburg, VA; Jayashree Mani, Magique Biotherapeutics LLC, Ashburn, VA; Russell Jaffe, MAGique BioTherapeutics, LLC, Ashburn, VA The study tested the hypothesis that RMJH-111b 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 in a proprietary formulation of inverted micellar nanodroplets designed to enhance intestinal uptake and cell delivery of active constituents. "Though this was a small proof-of-concept study, the data suggest that this novel drug can lower blood pressure safely and effectively with considerable safety and tolerability," said Russell Jaffe, M.D., Ph.D., CEO. "We look forward to conducting a Phase 3 trial with RMJH-111b, a 'first in class' new category of potential high value treatments for essential hypertension. Minutes of the end of Phase 2 meeting with the Cardiovascular and Renal Advisory Committee of the FDA confirm all five critical categories for drug approval are included in the Company's roadmap and adequately addressed in the pivotal trial design. We also are pleased to have the support of preeminent thought leaders in hypertension, who will be leading our study as principal investigators." In the study, forty-one hypertensive people were screened, twenty-two qualified to be enrolled and twenty-one completed the 10 day inpatient trial. 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. ABPM 24h mean net blood pressure changes day, night and 24º are as follows: SBPday, DBPday, SBPnight, DBPnight, SBP24º, DBP24º, SBP+DBP24º -6.2, -2.3, -4.9, -1.3, -6.6, -2.8, -9.4 One individual was excluded because her systolic blood pressure (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 <0.05 (level required for drug approval) would have been achieved. About RMJ Holdings, LLC RMJ Holdings, LLC (RMJH) is a private Limited Liability Company domiciled in Ashburn and Vienna, Virginia. RMJH's mission is to develop promising drug candidates that utilize its patented inverted micellar technology to address large unmet or poorly met needs in cardiovascular medicine followed by a platform of metabolic chronic illnesses. The core technology enhances the safer uptake and more effective delivery of deficient essential cell minerals.
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