TSX-049

A differentiated oral Testosterone Replacement Therapy

TSX-049 is a novel, oral formulation of Testosterone (T) containing Testosterone Undecanoate (TU) that is designed to help restore normal Testosterone levels in males with hypogonadism.

By utilizing TesoRx's proprietary pro-liposomal delivery platform to deliver modified Testosterone, TSX-049 is anticipated to have the following advantages:

  • No supra-physiological peak Testosterone levels

  • Minimal or 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

TSX-049 successfully completed the first part of a multiple formulation study in canines and the initiation of the second and final part of the study in collaboration with ASKA Pharmaceutical. Successful completion of the study would allow for a human clinical trial to be initiated in Q2 2020 with potential U.S. Food and Drug Administration approval as soon as 2023.

Significant unmet needs

Approximately 39 percent of men over the age of 45 are believed to be hypogonadal and potentially eligible for Testosterone Replacement Therapy (TRT). Current testosterone products come with significant lifestyle restrictions for patients like needing to cover their skin or not have physical contact to reduce the risk of testosterone transference to loved ones.

T-Trials funded by the NIH results show TRT benefits 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.

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Primary Outcomes in the Three Main Trials of the Testosterone Trials.

Sexual function

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).

Physical Function

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.

Vitality

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.