A highly differentiated Oral Testosterone Replacement Therapy.
THG-1001 has the potential to be a best-in-class oral testosterone undecanoate (TU) formulation for treating male hypogonadism.
By utilizing TesoRx's proprietary pro-liposomal delivery platform to deliver modified Testosterone, THG-1001 is anticipated to have the following advantages:
- Would not generate supraphysiological 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
It has already 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.
It has been estimated that a staggering 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 $2.4Billion annually in the USA alone. TesoRx plans to also unlock international value through a licensing transaction closed with Aspen Pharmacare in 2014 and future joint ventures in Europe, Japan, China and the Middle East.
TesoRx is pursuing a 505(b)(2) FDA approval pathway for THG-1001 after conducting Phase 2 Studies with its first generation TSX-002 unmodified oral Testosterone candidate. TSX-002 was found to be more beneficial for pediatrics and the company is pursuing a CDGP orphan indication in addition to the second generation THG-1001 treatment for hypo-gonadal men.
An IND has recently been filed for THG-1001 and a dose-ranging / titration study will be completed in 2016 with the filing of an NDA anticipated in 2018.
"T-Trials" funded by the NIH results show TRT benefiting men
The 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...