On August 14, 2018 GTx, Inc. (Nasdaq:GTXI) reported financial results for the second quarter ended June 30, 2018 and highlighted recent accomplishments and upcoming milestones (Press release, GTx, AUG 14, 2018, View Source;p=irol-newsArticle&ID=2363550 [SID1234528880]).
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"During the second quarter, we achieved a key milestone for the company when we completed patient enrollment in our placebo-controlled, Phase 2 ASTRID Trial of enobosarm in postmenopausal women with stress urinary incontinence (SUI)," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "Due to overwhelming interest from women wanting to participate in the clinical trial, we completed enrollment several months ahead of schedule and exceeded the 400 patients planned. We look forward to reporting top-line results early in the fourth quarter of 2018."
Clinical Highlights and Anticipated Milestones
Stress Urinary Incontinence (SUI):
Enobosarm, a Selective Androgen Receptor Modulator (SARM), is being evaluated in Phase 2 clinical development for SUI. Recent and upcoming important milestones are summarized as follows:
The Company has an ongoing randomized, double-blinded, placebo-controlled, Phase 2 trial to assess the efficacy and safety of enobosarm administered orally in post-menopausal women with SUI compared to placebo. More information about the ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder) Trial can be found here.
In April, the Company completed patient enrollment in the ASTRID Trial several months ahead of schedule, enrolling 493 women at over 60 clinical trial centers across the United States. Top-line results are expected early in the fourth quarter of 2018.
On May 18, 2018, a podium presentation entitled "Oral Enobosarm Shows Promising Activity in Post-Menopausal Women with Stress Urinary Incontinence: Results of a Phase 2 Study," took place at the 2018 American Urological Association (AUA) annual meeting. The presentation updated results from the Phase 2 POC clinical trial of enobosarm. Details of the AUA presentation can be found here and are summarized below:
At the end of the 12-week treatment period, all 18 enobosarm-treated women showed clinically meaningful (50 percent or greater) reductions in stress urinary incontinence episodes per day compared to baseline.
The reduction in incontinence episodes was sustained, or durable, well beyond the 12-week treatment period.
There were no serious adverse events reported and reported adverse events were minimal and included headaches, nausea, fatigue, hot flashes, insomnia, muscle weakness and acne. Mild transient elevations in liver enzymes that were within normal limits were observed, except for one patient with levels greater than 1.5 times the upper limit of normal which returned to normal following her 12-week treatment period. Reductions in total cholesterol, LDL-C, HDL-C and triglycerides were also observed.
The ASTRID Trial protocol includes a four-month, off-drug durability assessment in the first 225 patients enrolled. These data will be announced simultaneously with the ASTRID results. Once the 225-patient cohort completes the four-month, off-drug durability assessment, those patients will have, at their discretion, the option to enter an additional five-month, off-drug extension study to provide a total of nine months of off-drug durability assessment.
The Company also has initiated an open-label safety extension study. Each participating patient will receive 3 mg of oral enobosarm on a daily basis.
Prostate Cancer:
The Company has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer (CRPC). The Company has ongoing mechanistic preclinical studies designed to select the most appropriate compound to potentially advance into a first-in-human clinical trial.
Second Quarter 2018 Financial Results
As of June 30, 2018, cash and short-term investments were $45.7 million compared to $43.9 million at December 31, 2017.
Research and development expenses for the quarter ended June 30, 2018 were $8.0 million compared to $4.4 million for the same period of 2017.
General and administrative expenses for the quarter ended June 30, 2018 were $2.2 million compared to $2.0 million for the same period of 2017.
The net loss for the quarter ended June 30, 2018 was $10.0 million compared to a net loss of $6.4 million for the same period in 2017.
Net loss for the six months ended June 30, 2018 was $23.6 million compared to a net loss of $12.7 million for the same period in 2017.
GTx had approximately 24.0 million shares of common stock outstanding as of June 30, 2018. Additionally, there are warrants outstanding to purchase approximately 5.3 million shares of GTx common stock at an exercise price of $8.50 per share and approximately 3.3 million shares of GTx common stock at an exercise price of $9.02.
About the Phase 2 Proof-of-Concept Clinical Trial
The single-arm, open-label Phase 2 clinical trial is evaluating enobosarm in postmenopausal women with SUI, and is the first clinical trial to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI. This clinical trial is closed to enrollment; more information about the clinical trial can be found here.
About the Phase 2 ASTRID Clinical Trial
In addition to the Phase 2 proof-of-concept clinical trial that was presented at AUA, GTx also has a larger, ongoing, placebo-controlled Phase 2 clinical trial evaluating enobosarm in postmenopausal women with SUI. The study, called ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder), completed enrollment (n=493) and is being conducted at over 60 clinical trial centers across the United States. Top-line results are expected early in the fourth quarter of this year. More information about the ASTRID clinical trial can be found here.
About Enobosarm and SUI
Enobosarm (GTx-024), a selective androgen receptor modulator (SARM), has been evaluated in 27 completed or ongoing clinical trials enrolling over 2,100 subjects, in which approximately 1,500 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated. The rationale for evaluating enobosarm as a treatment for SUI is supported by preclinical in vivo data demonstrating increases in pelvic floor muscle mass following treatment with GTx’s SARM compounds, including enobosarm, and the proof-of-concept Phase 2 clinical trial of enobosarm 3 mg for the treatment of postmenopausal women with SUI.
About Stress Urinary Incontinence
Stress urinary incontinence (SUI) refers to the unintentional leakage of urine during activities that increase abdominal pressure such as coughing, sneezing or physical exercise. SUI, the most common type of incontinence suffered by women, affects up to 35 percent of adult women. There are a variety of treatments that are used to treat SUI in women, such as behavioral modification and pelvic floor physical therapy, especially as initial treatment options. As the condition worsens however, bulking agents and surgical procedures are often the most widely used treatments.