Marius Pharmaceuticals Completes Efficacy Phase 3 Study

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Marius Pharmaceuticals, a specialty pharmaceutical company, today announced positive preliminary data for their Phase 3 clinical trial evaluating SOV-2012-F1 in men suffering from hypogonadism. SOV-2012-F1 is Marius’ proprietary oral testosterone replacement therapy (TRT) uniquely utilizing phytosterols to enhance absorption through the lymphatic system. The predictable pharmacokinetics of Marius’ formulation should provide the framework for improved therapeutic effect in clinical practice, better patient compliance, and a reduction in adverse events associated with poor therapeutic control. Together, these advantages should result in true symptom relief for the millions suffering from this chronic condition globally.

“We are extremely pleased with the results of the trial thus far,” said Om Dhingra, Chief Executive Officer for Marius Pharmaceuticals. “This positive preliminary data supports our belief that, if approved, SOV-2012-F1 may offer a safe, effective, and convenient oral treatment for men suffering from hypogonadism.”

Affecting an estimated 22 million men (7% of the population) of all ages in the US alone, with corresponding higher global impact, hypogonadism is characterized by inadequate testosterone production due to issues with the testes or pituitary gland. Although widely recognized as important for sexual health, testosterone also has roles in neurological, musculoskeletal, cardiovascular, and pulmonary health. Patients afflicted with this under-researched endocrine condition experience symptoms such as fatigue and low libido, with an increased risk for type 2 diabetes, anemia, and decreased bone density. Men with low testosterone often suffer from the co-morbidities of obesity, diabetes, osteoporosis, or asthma.

Current treatment paradigms for hypogonadism focus on restoring testosterone levels using TRT, primarily administered either by injection or topical application. In 2018, an estimated 1.8 million men are on active TRT treatment. However, current treatments are burdensome, provide inconsistent daily relief, and in the case of topical (transdermal) products, have a black box warning due to the risk of transfer to partners and/or children. TRT intramuscular options currently on the market often result in prolonged peaks and troughs of testosterone levels. This pattern produces emotional highs and depressive lows for many patients. As a result, many eligible patients do not start treatment. Of those who do begin treatment, one third of patients discontinue within 12 months, primarily due to a lack of symptom improvement

Marius Pharmaceuticals’ novel and proprietary SOV-2012-F1 oral formulation of testosterone undecanoate seeks to address these concerns. Its innovative formulation enhances absorption and provides convenient oral dosing, which in turn should increase compliance, reduce adverse events, and provide consistent and predictable symptom relief, as supported by preliminary Quality of Life data. SOV-2012-F1 provides higher levels of free testosterone and is the only product under development containing phytosterol esters for improved absorption and tolerability. In addition to providing stable testosterone levels, its convenient oral administration removes the burden of repeated injections or topical applications. Based on the 90-day efficacy set of patient-reported outcomes, SOV-2012-F1 performed better than the leading topical gel in most key male quality of life measures, with patients seeing a greater improvement in emotional well-being, energy levels, sexual desire, erectile function, and prostate symptom scores.

“For the first time, oral TRT products are coming to the market, representing a paradigm shift that is greatly needed for men suffering from hypogonadism” said Shalin Y. Shah, Chief Financial Officer for Marius Pharmaceuticals. “We believe that the novel characteristics of SOV-2012-F1 will make it an ideal solution to this largely unmet medical need.”