Myovant Sciences Announces Late-Breaking Oral Presentation of Phase 3 LIBERTY 1 & 2 Study Results at 2019 American Society fo...
October 10 2019 - 8:30AM
Myovant
Sciences (NYSE: MYOV), a
healthcare company focused on developing innovative treatments for
women's health and prostate cancer, today announced that results
from its Phase 3 LIBERTY 1 & 2 studies of relugolix combination
therapy in women with heavy menstrual bleeding associated with
uterine fibroids will be presented in the late-breaking oral
session at the 2019 American Society for Reproductive Medicine
(ASRM) Scientific Congress, which is being held October 12-16 in
Philadelphia, Pennsylvania.
Both Phase 3 studies met their primary efficacy endpoint with
relugolix combination therapy demonstrating significant reduction
in heavy menstrual bleeding (p < 0.0001) in women with uterine
fibroids. Key secondary endpoints including a reduction in mean
menstrual blood loss volume, achievement of amenorrhea (defined as
no or negligible menstrual bleeding), reduction in pain associated
with uterine fibroids, improvement in anemia, reduction in distress
from bleeding and pelvic discomfort, and reduction in uterine
volume were also met in both studies with statistical significance.
The safety profile of relugolix combination therapy in both studies
was generally well-tolerated with bone health maintained and
vasomotor symptoms comparable to those in the placebo group.
In addition, Myovant Sciences will present a poster on the
development and validation of the bleeding and pelvic discomfort
scale, a patient-reported outcome for women with heavy menstrual
bleeding associated with uterine fibroids.
Presentation details are as follows:
Oral Presentation
Session: OR03-15 - Late-Breaking 1 Title: Treatment of Symptoms
of Uterine Fibroids with Relugolix Combination Therapy: Efficacy
and Safety Results from the Phase 3 LIBERTY 1 Clinical
TrialAbstract #: O-265Presenter: Ayman Al-Hendy, MD, PhD,
University of Illinois College of MedicineSession Date & Time:
Wednesday, October 16, 12:00 p.m. EDTLocation: Pennsylvania
Convention Center – Exhibit Hall C
Poster Presentation
Session: Poster Session 2; P02-16 - FibroidsTitle: Measuring
Patient-Reported Outcomes in Women with Heavy Menstrual Bleeding
Associated with Uterine Fibroids: The Bleeding and Pelvic
Discomfort ScaleAbstract #: P-595 Presenter: Juliet Li, PhD,
Myovant SciencesSession Date & Time: Wednesday, October 16,
6:30–7:45 a.m. EDT Location: Pennsylvania Convention Center – Expo
Hall
Phase 3 LIBERTY Program Myovant Sciences’ Phase
3 clinical program for uterine fibroids consisted of two
multinational, replicate pivotal clinical studies (LIBERTY 1 and
LIBERTY 2) of relugolix combination therapy (relugolix 40 mg plus
estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with
uterine fibroids and heavy menstrual bleeding. Women in the LIBERTY
1 and LIBERTY 2 studies underwent a screening period requiring up
to two menstrual cycles to document heavy menstrual bleeding and
were randomized in a 1:1:1 ratio to one of three groups. Women
received treatment either with relugolix combination therapy for 24
weeks, relugolix 40 mg once daily monotherapy for 12 weeks followed
by relugolix combination therapy once daily for an additional 12
weeks, or placebo once daily for 24 weeks.
Myovant Sciences enrolled 388 women in LIBERTY 1 and 382
women in LIBERTY 2. To be enrolled, women must have had a monthly
menstrual blood loss volume of at least 80 mL in two consecutive
cycles or 160 mL in one cycle, measured by the alkaline hematin
method, a quantitative measure of menstrual blood loss from an
assessment of collected menstrual products.
Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies
were offered the opportunity to enroll in an active treatment
extension study in which all women receive relugolix combination
therapy for an additional 28-week period for a total treatment
period of 52 weeks, designed to evaluate the safety and sustained
efficacy of longer-term treatment. Upon completion of this 52-week
total treatment period, eligible women can elect to participate in
a second 52-week randomized withdrawal study designed to provide
two-year safety and efficacy data on relugolix combination therapy,
and to evaluate the need for maintenance therapy.
About Uterine Fibroids Uterine fibroids are
noncancerous tumors that develop in or on the muscular walls of the
uterus and are among the most common reproductive tract tumors in
women. In addition to an individual's genetic predisposition,
estrogen and progesterone are well known to play an important role
in the regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause
debilitating symptoms such as abnormal uterine bleeding, heavy or
painful periods, anemia, abdominal pain, backache, increased
abdominal girth and bloating, urinary frequency or retention,
constipation or painful defecation, pregnancy loss, painful
intercourse and, in some cases, infertility. These symptoms can
also lead to loss of productivity at work, limitations in normal
activities of daily living, and social embarrassment.
An estimated 5 million women in the U.S. suffer from
symptoms of uterine fibroids, and an estimated 3 million women are
inadequately treated by current medical therapy and require further
treatment.
About Relugolix Relugolix is a once daily, oral
gonadotropin-releasing hormone (GnRH) receptor antagonist that
reduces ovarian estradiol and progesterone production, hormones
known to stimulate the growth of uterine fibroids. Myovant Sciences
is also studying relugolix combination therapy in two Phase 3
clinical studies (SPIRIT 1 and SPIRIT 2) evaluating
endometriosis-associated pain. Relugolix monotherapy, 120 mg once
daily, is also being evaluated in the Phase 3 HERO study in men
with advanced prostate cancer.
About Myovant SciencesMyovant
Sciences aspires to be the leading healthcare company focused
on innovative treatments for women’s health and prostate cancer.
Myovant Sciences’ lead product candidate is relugolix, an oral,
once-a-day small molecule that acts as a GnRH receptor
antagonist. Myovant Sciences has three late-stage
clinical programs for relugolix ongoing in uterine fibroids,
endometriosis, and prostate cancer. Myovant Sciences is
also developing MVT-602, an oligopeptide kisspeptin-1 receptor
agonist, that has completed a Phase 2a study for the treatment of
female infertility as part of assisted reproduction. Takeda
Pharmaceuticals International AG granted Myovant
Sciences an exclusive, worldwide license to develop and
commercialize relugolix (excluding Japan and certain
other Asian countries) and an exclusive license to develop and
commercialize MVT-602 in all countries worldwide. For more
information, please visit Myovant Sciences’ website
at www.myovant.com. Follow @Myovant on Twitter and
LinkedIn.
Investor Contact: Frank Karbe Chief Financial
OfficerMyovant Sciences, Inc. investor@myovant.com
Media Contact: Albert LiaoDirector, Corporate
Communications Myovant Sciences, Inc. media@myovant.com
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