Re-Tune Study

Pivotal Phase 3 study for KYZATREX™

Pipeline

TRT Once a Day / Inflammation Related

Our Vision

To be a leading Endocrine Disease Management Company

Marius is focused on treating widespread conditions which have largely been caused by deficiencies in our endocrine system. Some of the most prevalent and deadly diseases in the US today have links to these deficiencies and due to the structural balances that must be achieved, optimal formulations are necessary to achieve effectiveness and safety.

The suffering of patients with these endocrine deficiencies have tremendous effects on functional abilities and downstream health consequences. At Marius, our goal is to improve the functional lives of patients and also reduce the risks of the downstream effects of Endocrine imbalance.

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Meet Our Team

News

Developing a New Standard of Care in Oral Testosterone.

Our vision is to bring a safe and efficacious treatment to the tens of millions of Men world-wide suffering from Low Testosterone. ​This under-diagnosed deficiency inflicts serious consequences on many aspects of male life.

Our lead candidate is a unique oral testosterone replacement therapy which overcomes many of the problems that have been typically associated with currently approved testosterone therapy products. Our proprietary delivery technology has achieved optimal absorption with all meal types resulting in a higher bioavailability of TU and a unique PK profile. Planning of Phase 3 studies are currently underway which will pave the way for FDA Approval.

Our Solution

Our proprietary oral T-replacement therapy uses testosterone undecanoate, a pro-drug of testosterone, to overcome many of the problems associated with earlier attempts to formulate and deliver oral testosterone for therapeutic treatment. Testosterone undecanoate (TU) is absorbed through the intestinal lymphatic system, overcoming difficulties related to oral testosterone absorption via the portal vein (the usual route for absorption of medication taken orally). We have used our proprietary delivery technology to achieve optimal formulation characteristics.

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Specific Marius proprietary formulation attributes include:

  • Ability to increase amount of formulated TU per unit dose.
  • Rapid and complete release of TU after oral administration to foster bioavailability
  • Unique PK profile
  • Low inter- and intra-subject variability in TU exposure, thereby minimizing the risk for testosterone elevations beyond the therapeutic range
  • Near normal DHT/T ratio

Our product is well tolerated and has not shown any significant adverse effects in hypogonadal men to date. If clinical trials continue to support the early profile of our product, when approved, it may offer a safe and effective oral T-replacement treatment for men suffering from low testosterone.

Orphan Indication

Marius holds an Orphan Designation for the treatment of Constitutional Delay in Growth and Puberty (CDGP) which affects over 100,000 boys in the US every year. Marius is developing its lead formulation to also address this crucial, unmet need for the youth population.

Key Benefits of Our Solution for CDGP: ​

Simple Oral Delivery

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Advantageous Release Profile

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Good Absorption

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Positive Efficacy & Safety Profile

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Marius is also looking to address Klinefelter's syndrome with Phase II Studies planned.

Testosterone Deficiency (Adult Men)

Testosterone (T) is the key androgen that both drives sexual development in men and underlies many vital physiological processes throughout the lifespan of the individual. Most of the testosterone in a man's body is produced in the testicles.
It plays an important role to:
There is a numerical range of testosterone levels (300 - 1100ng/dL) that are considered normal in adult men.
Testosterone can fall below normal levels. This can happen when a signaling problem between the brain and the testes causes a drop in the amount of testosterone that is being produced. Another reason below normal testosterone levels can occur is when the body simply can't produce enough testosterone. When a man’s testosterone falls below a level of around 300ng/dL, it’s generally considered to be low.
It's natural for men to produce less testosterone as they age. What's not a natural part of aging is a medical condition known as male hypogonadism — which means there is less testosterone than normal. Symptoms include reduced sexual function, depressed mood, and decreased energy.

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Hypogonadism is often misdiagnosed as a host of other maladies, including depression and erectile dysfunction. It is conservatively estimated that adult male hypogonadism affects 19 million American men, up to 88% of who go untreated.

The NIH has defined male hypogonadism as a condition in which the testes do not secrete hormones, such as testosterone, in the manner expected. Primary hypogonadism involves a malfunction of the testes themselves and may result from chromosome abnormalities (e.g. Klinefelter’s syndrome), local testicular surgery/disease, infection, mumps orchitis, radiation and renal failure. Central (or secondary) hypogonadism involves a defect in the pituitary or hypothalamus and may result from hypopituitarism, selective gonadotrophic deficiency, severe systemic illness or the patient being severely underweight. Additionally, healthy aging men experience a variety of hormonal changes, including decreasing serum testosterone levels.
Current treatment guidelines focus on the restoration of the normal physiological testosterone level through the use of exogenous testosterone preparations.
The health consequences of low testosterone in adult men can be quite wide-ranging*, and can lead to increased risk of:
* Source: Corona et al., 2012. Expert Opin. Emerging Drugs (2012) 17(2):239-259