Pharma

Pill for low testosterone in men heads for phase 2 clinical trials

Options for low testosterone treatments for men could expand if all goes as planned for a firm that's developing an oral drug and preparing for phase 2 trials.

Company name: Teso Rx Pharma.

Industry: Pharmaceuticals.

Location: Menlo Park, California.

Solution/product: TesoRx Pharma is currently developing TSX-002, an oral testosterone replacement therapy for men with hypogonadism. Its delivery system is intended to provide a convenient, outpatient method of delivering normal physiological levels of testosterone without the side effects associated with abnormally high levels of testosterone and other delivery methods.

Money raised: $5.9 million of a $6.6 million offering, according to a U.S. Securities and Exchange Commission filing. The company raised an undisclosed series A in 2010.

How it will be used: TesoRx held its first pre-IND meeting with the U.S. Food and Drug Administration in March 2011 and recently completed phase 1 trials. It’s now headed for phase 2 trials, according to a company rep.

Investors: Undisclosed.

Management team: CEO/co-founder TR Thirucote was vice president of pharmaceutical sciences at Roxro Pharma, which developed a nasal spray for use in postoperative pain treatment and was acquired by Luitpold Pharmaceuticals in 2010. With co-founder/chief science officer Guru Betageri and co-founder Will Roberts, he runs TesoRx as a virtual company that licenses compounds from small and midsized pharmaceutical companies and commercializes them.

Market size: The estimated prevalence of hypogonadism varies by study, depending on age groups tested and what testosterone level is considered “normal.” TesoRx says about 9 million men in the U.S. are affected by low testosterone — which can cause sexual dysfunction, depression and increased body fat — although only 10 percent of them receive treatment.

Increasing off-label use of testosterone replacement drugs has caused some controversy in recent years and has likely contributed to the rising sales of testosterone replacement therapies, which hit $1.6 million in 2011, according to Bloomberg data.

Competitors: There are no FDA-approved oral therapies on the market, but other testosterone replacement therapies include Solvay Pharmaceuticals’ (Abbott) AndroGel, Eli Lilly’s transdermal Axiron, Auxillium Pharmaceuticals and GlaxoSmithKline’s Testim gel and BioSante’s Bio T-Gel.  Repros Therapeutics also has clinical-stage oral drug Androxal.