A differentiated oral Testosterone Replacement Therapy
TSX-011 is a novel oral formulation of Testosterone (T) containing Testosterone Undecanoate (TU) that is designed to help restore normal T levels in males with hypogonadism. By utilizing TesoRx's proprietary pro-liposomal delivery platform to deliver modified Testosterone, TSX-011 is anticipated to have the following advantages:
- No supra-physiological peak T levels (a primary FDA concern).
- Minimal (potentially no) food effect, and no need to dose with high fat meal.
- Optimized PK profile with potential for once-a-day dosing.
- Greater safety and convenience compared to existing topical and injectable standard of care treatments.
TesoRx is pursuing a 505(b)(2) FDA approval pathway for TSX-011 after conducting Phase 2 Studies in 200+ patients with its first generation TSX-002 unmodified oral Testosterone candidate. It is currently conducting Phase 1/2a clinical studies and expecting Phase 2 read-out by September 2018. A pivotal Phase 3 study is planned for early 2019.
It has been established that a safe oral Testosterone Replacement Therapy (TRT) alternative would be very well received in the market given significant safety and convenience concerns with the current standard treatments. Injectibles are painful and the FDA has placed black box warnings to guard against the person-to-person transference of gel products.
An estimated 39% of men over the age of 45 are believed to be hypogonadal and potentially eligible for TRT. Although the market for TRT has declined in 2014 due to a slowdown in "Low-T" DTC marketing, treatment revenues are holding firm at about $2.4+ Billion annually in the USA alone.
"T-TRIALS" FUNDED BY THE NIH RESULTS SHOW TRT BENEFITING MEN
A comprehensive study, led by the Perelman School of Medicine at the University of Pennsylvania and funded by the National Institutes of Health involved 790 men 65 and older with low testosterone levels for their age.
Men reported moderate increases in their interest in sex, their performance and erections. There was also a smaller degree of improvement in mood, vitality and walking activity. Read more...
Primary Outcomes in the Three Main Trials of the Testosterone Trials.
The primary outcome of the Sexual Function Trial (Panel A) was the change from baseline in the score for sexual activity (question 4) on the Psychosexual Daily Questionnaire (PDQ-Q4; range, 0 to 12, with higher scores indicating more activity).
The primary outcome of the Physical Function Trial (Panel B) was the percentage of men who had an increase of at least 50 m in the distance walked during the 6-minute walk test.
The primary outcome of the Vitality Trial (Panel C) was the percentage of men who had an increase of at least 4 points in the score on the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue scale (range, 0 to 52, with higher scores indicating less fatigue). P values were calculated with the use of a linear random-effects model for sexual activity and logistic random-effects models for walking ability and vitality. The I bars represent standard deviations.