TX-001HR (Oral Estradiol + Progesterone)

WHAT IT IS:

TX-001HR is a novel combination of 17ß-estradiol and progesterone using SYMBODA technology, under investigation for treating vasomotor symptoms (VMS) related to menopause. TX-001HR is believed to be the first and only combination drug product candidate designed to replace the 17ß-estradiol and progesterone hormones the ovary has nearly stopped producing. About VMS

DEVELOPMENT PHASE: PHASE 3 –THE REPLENISH TRIAL

The purpose of the Replenish Trial is to evaluate an investigational bio-identical medication that may help reduce the frequency and severity of VMS symptoms, particularly daily hot flashes and night sweats often experienced during menopause.

The Phase 3 Replenish Trial was fully enrolled Q3 2015. Topline data anticipated Q4 2016 – Q1 2017.

Replenish Trial Study Design Summary
Projected number of subjects	1,750
Projected number of US sites	~110
Treatment arms (n=400/arm)	Estradiol 1 mg/progesterone 100 mg Estradiol 0.5 mg/progesterone 100 mg Estradiol 0.5 mg/progesterone 50 mg Estradiol 0.25 mg/progesterone 50 mg Placebo
Length of study	12-month study for endometrial safety with 12-week vasomotor substudy endpoints
Endpoints	Vasomotor substudy: number and severity of hot flashes (Weeks 4 and 12) Endometrial safety: incidence of endometrial hyperplasia (12 months)

ABOUT VASOMOTOR SYMPTOMS (VMS)

It is estimated that more than 90% of women experience VMS, particularly frequent hot flashes and night sweats during menopause. Most rate the severity of their hot flashes as moderate to severe.¹

Kingsberg S, Wysocki S, Magnus L and Krychman M. Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) Survey. J Sex Med. 2013;10:1790–1799.