RALEIGH, N.C., June 11, 2021 —Marius Pharmaceuticals, a patient-centric healthcare company focusing on therapies designed for hypogonadism, more commonly known as testosterone deficiency, today announced the publication of a study on the effects of oral testosterone undecanoate KYZATREX™ on ambulatory blood pressure in hypogonadal men in The Journal of Clinical Hypertension.
“Effects of Oral Testosterone Undecanoate KYZATREX™ on Ambulatory Blood Pressure in Hypogonadal Men”was published by William B. White, M.D., Professor, Cardiology Center, University of Connecticut School of Medicine, Farmington, and former President of the Hypertension Society of North America, Roger Rittmaster, MD, an endocrinologist in Camden, Maine, and Om Dhingra and James Bernstein from Marius. This newly published study shows small increases in ambulatory BP following 120 days on the oral testosterone undecanoate with a plateau and no further changes at 180 days. Changes in ambulatory BP were minimal in patients not taking antihypertensive therapies.
The publication of these results marks a significant milestone in the field of testosterone therapy as ambulatory blood pressure monitoring (ABPM) is the most accurate means to detect small BP changes in clinical trials and practice. Lead author William B. White, M.D. commented, “The changes in ambulatory BP were quite minimal in our study and of no clinical significance in normotensive men, a first in the testosterone space.” As testosterone therapy evolves past injections and gels towards the oral formulations, it is important to determine off-target effects on BP and to be able to compare these effects across the various therapies. Shalin Shah, Co-CEO of Marius commented, “We are extremely proud of the blood pressure data produced across all patient groups. If approved by the FDA, KYZATREX™ has the potential to provide greater clarity to both the physician and patient community on expected blood pressure changes.”
KYZATREX™, if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX™ in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose, titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences during 2021.
The FDA has conditionally accepted KYZATREX™ as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.
About Testosterone and Hypogonadism
Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory processes. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone.
Hypogonadism is also the most common cause of secondary osteoporosis in men. Beyond these diseases, hypogonadism is a common comorbidity in a broader set of conditions from Type-2 diabetes to Non-Alcoholic Steatohepatitis (NASH).
About Marius Pharmaceuticals
Marius is a patient-centric healthcare company focusing on therapies designed for hypogonadism or testosterone deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of testosterone deficiency which include increased inflammation and fatigue. For more information, please visit www.mariuspharma.comStudy: Effects of Oral Testosterone Undecanoate KYZATREX™ on Ambulatory Blood Pressure in Hypogonadal Men