RMJ Holdings announced its first drug candidate, RMJH-111B for essential hypertension, is being prepared for Phase 3 development. Inverted micellar technology enhances safer and more tolerable uptake and more effective delivery of deficient essential cell minerals, including magnesium. By combining inverted micellar technology with magnesium, RMJH opens a 'first in class' new category of high value treatments for essential hypertension. A successful Phase 1 /2 trial demonstrated substantial lowering of blood pressure safely and effectively, data which have been reviewed with the U.S. Food and Drug Administration (FDA). RMJH has designed a pivotal Phase 3 clinical trial for RMJH-111B, has an Investigational New Drug (IND) application allowed, has clinical sites identified, and plans to move forward with a 505(b)(2) pathway for RMJH-111B development.
Chronic latent magnesium deficiency (CLMD) afflicts over half the American population. A deficit of cellular magnesium is associated with multiple disease risks, particularly cardiovascular and metabolic. RMJH's initial development focus is hypertension. Additional drug indications form a platform in cardiovascular medicine along with a pipeline of other metabolic indications.
Because of its unique delivery properties, RMJH's proprietary inverted micellar technology has enabled a fundamental, composition-of-matter patent for RMJH-111B (patent # 8,017,160). The critical claims in the patent cover enhanced uptake and more effective delivery of oral magnesium to cells functionally impaired due to deficits in this required electrolyte. The European patent has recently issued, as have other global patents.
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"We look forward to commencing our Phase 3 pivotal trial. 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," Dr. Russell Jaffe, MD, Ph.D., CEO and Chairman said.
Despite an abundance of hypertensive drugs, every approved hypertension medication is known to impair magnesium uptake and/or increase its loss from the body, which thereby reduces the drug's effectiveness due to induced CLMD. The need for safer and more effective cardiovascular medications has been called for by the US Center for Disease Control (CDC) and a consortium of cardiovascular organizations. In addition, two in three Americans are chronically magnesium deficient due to declining dietary availability at a time when needs for magnesium have doubled. In the last few decades, need for magnesium has doubled while availability has been reduced by half.