Bayer announces enrollment of first U.S. patient in Phase III trials of vilaprisan in uterine fibroids

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Aug 29, 2017, 09:00 ET

WHIPPANY, N.J., Aug. 29, 2017 /PRNewswire/ -- Bayer announced that the first U.S. patient has been enrolled in ASTEROID (Assess Safety and Efficacy of Vilaprisan in Subjects with UTERine FibrOIDs) – a Phase III clinical trial program assessing the safety and efficacy of vilaprisan, an oral and selective progesterone receptor modulator (SPRM), in women with symptomatic uterine fibroids.^1,2

"Bayer has a rich legacy in women's health research, and we are dedicated to investigating vilaprisan as a potential medical treatment option for women with symptomatic uterine fibroids," said Dario Mirski, M.D., Bayer's senior vice president and head of medical affairs for the Americas. "The initiation of this trial reinforces our ongoing commitment to finding innovative solutions for women suffering from gynecological conditions."

Uterine fibroids, also known as leiomyomas, are the most common benign uterine tumors in women of reproductive age.³ A U.S. study estimates that more than 80% of African American women and nearly 70% of Caucasian women may develop uterine fibroids by age 50.⁴ It is estimated that 20% to 50% of women with uterine fibroids may experience symptoms.⁵ The two most common symptoms of uterine fibroids for which women seek treatment are abnormal uterine bleeding (including heavy or prolonged menstrual bleeding) and pelvic pressure.⁶

Treatment options depend on the size, number and location of the tumors as well as the patient's age and desire to maintain fertility.⁵ To date, there are no FDA-approved drug therapies for heavy menstrual bleeding associated with uterine fibroids.⁷Surgical management, such as hysterectomy (removal of the uterus) and myomectomy (removal of the fibroids), remains the main course of action for the treatment of patients with symptomatic uterine fibroids.⁸ According to a survey in the American Journal of Obstetrics & Gynecology, 79% of women indicated it was important to have a uterine fibroids treatment option that did not involve invasive surgery.⁹

"Uterine fibroids represent a great unmet medical need in gynecology as there are limited treatment options," said James Segars, M.D., ASTEROID lead investigator and director of the Division of Reproductive Science and Women's Health Research at the Johns Hopkins Department of Gynecology and Obstetrics. "The enrollment of the first U.S. patient in this Phase III trial program represents a major step forward in better understanding vilaprisan as a potential non-surgical option for women suffering from uterine fibroid symptoms, including heavy menstrual bleeding."

About ASTEROID Phase III Clinical Trial Program
The ASTEROID (Assess Safety and Efficacy of Vilaprisan in Subjects with UTERine FibrOIDs) Phase III clinical study program will include several studies to investigate the efficacy and safety of vilaprisan 2 mg in patients with symptomatic uterine fibroids.^1,10 The program aims to screen more than 1,400 women and randomize 750 patients at up to 240 centers in the U.S. Efficacy measures of the trial program will include the effect on heavy menstrual bleeding (amenorrhea rate, controlled bleeding) and reduction in fibroid size.¹¹

About Vilaprisan
Vilaprisan is a selective progesterone receptor modulator (SPRM), which is currently in clinical development for the oral treatment of symptomatic uterine fibroids.² Progesterone, a naturally occurring hormone in the body, is critical to the development of the fibroid.⁸Vilaprisan is thought to work by binding to the progesterone receptor and modulating its activity.

About Gynecology at Bayer
Bayer is committed to delivering Science For A Better Life by advancing a portfolio of innovative treatments. Women's health, including family planning and menopause management, has been at the center of Bayer's gynecology franchise for many years. Today, our research efforts focus on finding new treatment options for gynecological diseases with a high medical need, such as uterine fibroids, which affect a large number of women in our society. The gynecology franchise at Bayer includes several investigational compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company's approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated.

Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

Media Contact:
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Forward-Looking Statement
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

¹ Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 6). Available at https://clinicaltrials.gov/ct2/show/record/NCT03194646. Accessed August 21, 2017.
²Human Reproduction. Wagenfeld A., Bone W., Schwede W, Fritsch M, Fischer O, Moeller C. "BAY 1002670: a novel, highly potent and selective progesterone receptor modulator for gynaecological therapies." Volume 28, Issue 8.
³ New England Journal of Medicine. Donnez J. et al. "Ulipristal Acetate versus Leuprolide Acetate for Uterine Fibroids." Volume 366, Issue 5.
⁴ American Journal of Obstetrics & Gynecology. Baird D, Dunson D, Hill M, Cousins D and Schectman J, "High Cumulative Incidence Of Uterine Leiomyoma In Black And White Women: Ultrasound Evidence." Volume 188, Issue 1.
⁵ Journal of Obstetrics and Gynaecology Canada. Allaire C, Laberge PY, Leyland L and Vilos GA, "The Management Of Uterine Leiomyomas." Number 318.
⁶ACOG Practice Bulletin No. 96. American College of Obstetricians and Gynecologists. Obstet Gynecol 2008;112:387–400.
⁷ Human Reproduction Update. Segars J. et al. "Proceedings from the Third National Institutes of Health International Congress on Advances in Uterine Leiomyoma Research: comprehensive review, conference summary and future recommendations." Volume 20, Number 3.
⁸ Reproductive Sciences. Doherty L. et al. "Uterine Fibroids: Clinical Manifestations and Contemporary Management." Volume 29, Number 9.
⁹ American Journal of Obstetrics & Gynecology. Borah B. et al. "The impact of uterine leiomyomas: a national survey of affected women."
¹⁰ Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids Compare to Ulipristal (ASTEROID 5). Available at https://clinicaltrials.gov/ct2/show/NCT03240523. Accessed August 21, 2017.
¹¹Data on File.