Myovant Sciences (NYSE: MYOV), a healthcare company focused on
redefining care for women’s health and prostate cancer, today
announced that the journal Obstetrics & Gynecology has
published three abstracts detailing additional efficacy and safety
findings from the Phase 3 LIBERTY 1 and 2 studies of relugolix
combination therapy (relugolix 40 mg plus estradiol 1.0 mg and
norethindrone acetate 0.5 mg) in women with heavy menstrual
bleeding associated with uterine fibroids. The abstracts were
originally accepted for presentation in oral and poster sessions at
the American College of Obstetricians and Gynecologists (ACOG) 2020
Annual Clinical and Scientific Meeting, which was cancelled due to
the COVID-19 pandemic.
“These additional findings reinforce the positive
impact on pain and quality of life achieved by relugolix
combination therapy in the LIBERTY studies in women suffering from
uterine fibroids,” said Juan Camilo Arjona Ferreira, M.D., chief
medical officer of Myovant Sciences. “Relugolix combination therapy
also preserved bone mineral density over 24 weeks of treatment,
again demonstrating the potential for a new treatment option that
may provide clinically-meaningful symptom relief and maintain bone
health.”
Abstracts are available in Obstetrics &
Gynecology. Details of the abstracts are as follows.
Relugolix Combination Therapy Reduced
Uterine Fibroid-Associated Pain in Two Phase 3 LIBERTY Studies
(Abstract #32B)
The pain-evaluable population included 127 and 150
women from LIBERTY 1 and 2 studies, respectively, who experienced
moderate to severe pain before randomization and completed the
24-week study. In an analysis of pooled data:
- 65% of women treated with relugolix combination therapy
reported no or minimal pain during menstrual days (maximum score of
1 on a 0 to 10 Numerical Rating Scale) compared to 19.3% for women
in the placebo group.
- 44.6% of women treated with relugolix combination therapy
reported no or minimum pain during non-menstrual days, compared to
21.6% of women in the placebo group.
Relugolix Combination Improves Quality of
Life in Phase 3 Studies of Symptomatic Uterine Fibroids (Abstract
#OP04-4D)
Women in both LIBERTY 1 and LIBERTY 2 studies
completed the validated Uterine Fibroid Symptom (UFS)-Quality of
Life (QoL) questionnaire:
- Women treated with relugolix combination therapy experienced
significant improvement in symptom severity (scale from 0 to 100
with higher scores indicating worse outcomes) from baseline to Week
24 (both studies p < 0.0001) from 55.1 to 23.4 compared with
60.3 to 49.2 for women in the placebo group in LIBERTY 1, and from
59.1 to 21.7 compared with 59.2 to 45.1 for women in the placebo
group in LIBERTY 2.
- Health-related QoL (scale from 0 to 100 with higher scores
indicating better outcomes) also improved significantly for women
treated with relugolix combination therapy from baseline to Week 24
(both studies p < 0.0001) from 37.2 to 74.0 compared with 33.5
to 44.9 for women in the placebo group in LIBERTY 1, and from 38.9
to 78.7 compared with 37.3 to 51.0 for women in the placebo group
in LIBERTY 2.
Bone Mineral Density Assessment with
Relugolix Combination Therapy: Results from the Phase 3 LIBERTY
Program (Abstract #OP04-2D)
Results demonstrated that relugolix combination
therapy preserved bone mineral density over 24 weeks in the LIBERTY
program. In contrast, relugolix monotherapy for 12 weeks was
associated with bone mineral density loss, which stabilized upon
transition to relugolix combination therapy for 12 weeks. These
data suggest that initiating treatment for uterine fibroids with
relugolix combination therapy represents a potential treatment
option for preserving bone mineral density while providing
long-term therapeutic benefit.
- In LIBERTY 1, treatment with relugolix combination therapy
resulted in a -0.36% mean change from baseline at Week 24 in lumbar
spine bone mineral density, compared to a -1.82% mean change for
women who started on relugolix monotherapy, and 0.05% change for
women in the placebo group.
- In LIBERTY 2, treatment with relugolix combination therapy
resulted in a -0.13% mean change from baseline at Week 24 in lumbar
spine bone mineral density, compared to a -2.12% mean change for
women who started on relugolix monotherapy, and -0.32% change for
women in the placebo group.
About the Phase 3 LIBERTY Program in
Uterine FibroidsMyovant’s 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 heavy menstrual bleeding associated
with uterine fibroids. 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. 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 received
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
could 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
FibroidsAffecting over
25% of women of reproductive age, 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, estrogens 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 heavy menstrual bleeding (frequently resulting in
anemia and fatigue), pain (including painful periods, abdominal
pain, painful intercourse, backache), increased abdominal girth and
bloating, urinary frequency or retention, constipation, pregnancy
loss, 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.
About RelugolixRelugolix is a once-daily, oral
gonadotropin-releasing hormone (GnRH) receptor antagonist that
reduces ovarian estradiol production, a hormone known to stimulate
the growth of uterine fibroids and endometriosis, and testicular
testosterone production, a hormone known to stimulate the growth of
prostate cancer. Myovant is developing a relugolix combination
tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone
acetate 0.5 mg) for women with uterine fibroids and for women with
endometriosis. Myovant is also developing a relugolix monotherapy
tablet (120 mg once daily) for men with advanced prostate
cancer.
About Myovant
Sciences Myovant Sciences aspires to be the
leading healthcare company focused on redefining care for women’s
health and prostate cancer. The company’s lead product candidate is
relugolix, a once-daily, oral GnRH receptor antagonist. The
company has three late-stage clinical programs for relugolix
in uterine fibroids, endometriosis, and prostate cancer. The
company 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, a subsidiary of Takeda
Pharmaceutical Company Limited, the originator of
relugolix, previously granted the company a 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. Sumitovant
Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon
Pharma Co., Ltd., is the majority shareholder of Myovant. For more
information, please visit the company’s website
at www.myovant.com. Follow @Myovant on Twitter and
LinkedIn.
Forward-Looking
StatementsThis
press-release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include all statements regarding Myovant
Sciences’ intent, belief, or expectations regarding future events
or results and can be identified by words such as “anticipate,”
“aspire,” “believe,” “can,” “continue,” “could,” “estimate,”
“expect,” “intend,” “likely,” “may,” “might,” “objective,”
“ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to
be,” “will,” “would,” or the negative or plural of these words or
other similar expressions or variations, although not all
forward-looking statements contain these identifying words. In this
press release, forward-looking statements include, but are not
limited to, statements and quotes regarding Myovant Sciences’
aspirations to be the leading healthcare company focused on
redefining care for women’s health and prostate cancer ;
characterizations and quotes regarding the LIBERTY studies,
including the positive impact on pain and quality of life achieved
by relugolix combination therapy in the LIBERTY studies and the
preservation of bone mineral density over 24 weeks of treatment;
and the potential for a new treatment option that may provide
clinically-meaningful symptom relief and maintain bone health.
Myovant Sciences’ forward-looking statements are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties, assumptions and other factors known
and unknown that could cause actual results and the timing of
certain events to differ materially from future results expressed
or implied by the forward-looking statements. Myovant Sciences
cannot assure you that the events and circumstances reflected in
the forward-looking statements will be achieved or occur and actual
results could differ materially from those expressed or implied by
these forward-looking statements. Factors that could materially
affect Myovant Sciences’ operations and future prospects or which
could cause actual results to differ materially from expectations
include, but are not limited to the risks and uncertainties listed
in Myovant Sciences’ filings with the United States Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed
on February 10, 2020, as such risk factors may be amended,
supplemented or superseded from time to time. These risks are not
exhaustive. New risk factors emerge from time to time and it is not
possible for Myovant Sciences’ management to predict all risk
factors, nor can Myovant Sciences assess the impact of all factors
on its business or the extent to which any factor, or combination
of factors, may cause actual results to differ materially from
those contained in any forward-looking statements. You should not
place undue reliance on the forward-looking statements in this
press release, which speak only as of the date hereof, and, except
as required by law, Myovant Sciences undertakes no obligation to
update these forward-looking statements to reflect events or
circumstances after the date of such statements.
Investor Contact: Frank Karbe
President, Chief Financial Officer Myovant Sciences, Inc.
investors@myovant.com
Media Contact:Albert
Liao Director, Corporate CommunicationsMyovant Sciences, Inc.
media@myovant.com
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