Marius Seeks FDA Approval of Testosterone Therapy

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Raleigh-based Marius Pharmaceuticals, led by several former GlaxoSmithKline scientists and executives, is making progress on its first potential drug.

Marius has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Kyzatrex, its novel treatment for hypogonadism, or testosterone deficiency, in men.

“Submission of our first NDA is an important milestone, bringing attention to the role of testosterone as a critical hormone and the multitude of effects it can have on our health system,” said Himanshu H. Shah, founder and executive chairman of Marius, in a prepared statement. “This is the culmination of over a decade of meticulous research and dedication and is just the beginning for Marius, as our deep pipeline will continue to further the research and development in this important therapeutic area.”

Due to “robust results” of Kyzatrex in safety and efficacy studies, Marius has requested a Priority Review that, if granted by the FDA, would result in an anticipated six-month review period.

Kyzatrex, an oral testosterone undecanoate softgel, showed “differentiated” results in both safety and efficacy studies compared to current options in testosterone replacement therapy for hypogonadism in men.

“We are extremely proud to have generated compelling efficacy and safety data in our Phase 3 trials,” said Om Dhingra, Ph.D., co-founder and chief executive officer of Marius. “We look forward to continuing to work collaboratively with the FDA, and if approved, Kyzatrex has the potential to become the standard of care as an essential treatment for patients struggling with hypogonadism globally.”

Marius said it intended to file a marketing authorization application with the European Medicines Agency in the second half of 2021.

In May 2020 the U.S. Patent and Trademark Office issued two key patents related to Kyzatrex, providing intellectual property protection to December 2030. The patents are in addition to granted patents in the European Union, Canada, China, Taiwan, Japan, New Zealand and other key markets, and pending applications elsewhere.

The allowed claims protect Kyzatrex, an innovative formulation of testosterone undecanoate designed to increase bioavailability and provide a favorable pharmacokinetic profile compared to other therapies.

Testosterone deficiency widespread

Hypogonadism occurs when the body does not produce adequate levels of testosterone, the primary sex hormone and anabolic steroid in males. 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.

Himanshu Shah
Himanshu Shah. -- Marius photo

At least 6 million symptomatic men suffer from hypogonadism in the United States, and over 100 million men globally have the condition. The resulting medical costs associated with men who have untreated hypogonadism and related comorbidities are more than $25 billion in the United States 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 ranging from type-2 diabetes to non-alcoholic steatohepatitis, a type of fatty-liver disease.

Because testosterone deficiency is central to several diseases, Marius indicated it would expand its research program to several clinical settings to further explore the role of adequate levels of testosterone in the body.

“With adequate testosterone levels, many downstream impacts could potentially be alleviated and also result in tremendous savings to our otherwise reactive healthcare system,” Shah said. 

Hypogonadism has become more prevalent in the general population but has not been fully addressed. “The hormone space is complicated, and clinicians have not had the best therapeutic to help manage this disease,” Shah said. 

Growth, IPO on horizon

Marius plans to grow “significantly” in 2021 in preparation for the launch of Kyzatrex and is considering an initial public offering of stock at some point in the future, Shah said.

The specialty pharmaceutical company, located on Six Forks Road in Raleigh, was founded in 2017. It is focused on treating widespread conditions that are largely caused by deficiencies in the endocrine system. 

Four members of the company’s seven-member executive management team spent time at GlaxoSmithKline, which has corporate operations in Research Triangle Park and manufacturing facilities in Zebulon. In addition to Dhingra, they include James Bernstein, chief scientific officer; Craig Metz, senior vice president of regulatory affairs; and Roger Rittmaster, chief medical officer.

Also on the team are Shalin Shah, chief financial officer and executive vice president for strategy; Ivy Fowler, executive director of operational strategy; and Amit Shah, executive vice president of manufacturing and supply chain.

Barry Teater, NCBiotech Writer
Tue, 01/05/2021 - 16:36