Myovant Sciences (NYSE: MYOV), a healthcare company focused on
redefining care for women and for men, today announced the
presentation of additional data from clinical studies of its
once-daily 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 data
were presented in virtual oral and poster sessions during the
European Society of Human Reproduction and Embryology (ESHRE)
virtual 36th Annual Meeting.
“The additional data being presented at the European Society of
Human Reproduction and Embryology Annual Meeting reinforce the
potential of relugolix combination therapy to offer women suffering
from uterine fibroids meaningful reduction in distress due to
bleeding, passing blood clots, and pelvic pressure, as well as
improvement in anemia,” said Juan Camilo Arjona Ferreira,
M.D., chief medical officer of Myovant Sciences. “Furthermore,
the data from our ovulation inhibition study showed inhibition in
100% of women on treatment as well as rapid return after stopping
treatment, potentially offering women the ability to control their
ovulation and fertility goals.”
Details of the presentations are as follows:
Relugolix combination therapy reduced patient-reported
distress from bleeding and pelvic symptoms and improved daily
activities in patients with uterine fibroids in the LIBERTY
program (oral presentation, O-024)
In the Phase 3 LIBERTY program, women were asked to provide
feedback (between 0 and 100) on the Bleeding and Pelvic Discomfort
(BPD) scale, which assesses distress due to heavy menstrual
bleeding, passing blot clots, and pelvic pressure/tightness, and
the Revised Activities (RA) scale (between 0 and 100), which
assesses physical and social activities.
- Reductions in distress on the BPD scale from baseline to Week
24 were significantly greater for women taking relugolix
combination therapy (48.4 point reduction) than placebo (17.4 point
reduction) (p < 0.0001).
- Improvements in physical and social activities on the RA scale
from baseline to Week 24 were significantly greater for women
taking relugolix combination therapy (45.1 point increase) than
placebo (15.8 point increase) (p < 0.0001).
- Responder rates (women reporting at least a 20-point change
from baseline to Week 24) were significantly higher for women
taking relugolix combination therapy (62.5% on BPD, 61.7% on RA)
than placebo (28.1% on BPD, 34.0% on RA) (all p < 0.0001).
Relugolix combination therapy improves hemoglobin levels
in anemic women with heavy menstrual bleeding due to uterine
fibroids: results from the LIBERTY Phase 3 program (oral
presentation, O-023)
In the Phase 3 LIBERTY program, approximately one-third of women
had anemia (hemoglobin ≤ 10.5 g/dL) at baseline. These women were
more likely to be Black/African American (65.2% versus 51.2% in
overall study population) and their baseline menstrual blood volume
was higher (mean: 285.5 mL versus 228.8 mL in overall study
population), where menstrual blood volume > 80 mL in a cycle is
defined as heavy menstrual bleeding.
- The percentage of women with a clinically-meaningful increase
in hemoglobin levels (> 2 g/dL) from baseline to Week 24 was
higher for women taking relugolix combination therapy (55.7%) than
placebo (11.7%) (p < 0.0001).
- The mean percentage increase in hemoglobin concentration from
baseline to Week 24 was significantly greater in women taking
relugolix combination therapy (23.0%) than placebo (6.4%) (p <
0.0001).
Suppression of ovarian activity during co-administration
of the oral gonadotropin-releasing hormone receptor antagonist
relugolix, estradiol, and norethindrone acetate in healthy female
volunteers (poster presentation, P-287)
In a Phase 1 open-label, single-arm ovulation inhibition study,
67 healthy premenopausal women were evaluated over an 84-day
treatment period (three cycles) to assess the effects of relugolix
combination therapy on ovulation inhibition, per the
Hoogland-Skouby assessment scale (score < 5). A post-treatment
follow-up period assessed time to the return of ovulation.
- Once-daily dosing with relugolix combination therapy resulted
in suppression of ovarian activity and inhibition of ovulation in
100% of women during the treatment period.
- Mean and median estradiol levels were between 30 and 44 pg/mL
during treatment.
- Ovarian activity resumed after treatment discontinuation, with
ovulation occurring a mean of 23.5 days after the last treatment
day.
- Relugolix combination therapy was generally
well-tolerated.
Myovant submitted a Marketing Authorization Application to the
European Medicines Agency in March 2020 and a New Drug Application
to the U.S. Food and Drug Administration in May 2020 for
relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg,
and norethindrone acetate 0.5 mg) for the treatment of women with
uterine fibroids. Myovant also recently reported positive data from
its second Phase 3 SPIRIT trial evaluating relugolix combination
therapy in women with endometriosis.
About the Phase 3 LIBERTY Program in Uterine
Fibroids Myovant’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 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 efficacy of longer-term treatment. Upon
completion of this 52-week total treatment period, eligible women
could elect to participate in a 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. Across studies, a response was defined as a menstrual
blood loss volume of less than 80 mL and a 50% or greater reduction
from baseline in menstrual blood loss volume during the last 35
days of treatment measured using the alkaline hematin method.
LIBERTY 1 and 2 met their primary endpoints (p < 0.0001) with
73.4% and 71.2% of women receiving relugolix combination therapy
achieving the responder criteria compared with 18.9% and 14.7% of
women receiving placebo at 24 weeks, respectively. On average,
women receiving relugolix combination therapy in both studies
experienced an 84.3% reduction in menstrual blood loss from
baseline at Week 24 (p < 0.0001). Bone mineral density was
comparable between the relugolix combination therapy and placebo
groups in LIBERTY 1 and 2. The distribution of the change in bone
mineral density, including outliers, was similar for the relugolix
combination therapy and placebo groups at 24 weeks, as assessed by
dual energy x-ray absorptiometry (DXA). The overall incidence of
adverse events in the relugolix combination and placebo groups was
comparable in both studies.
The open-label extension study also met its primary endpoint
with relugolix combination therapy demonstrating an 87.7% response
rate at one year, showing the durability of the response observed
in LIBERTY 1 and 2. In addition, women experienced, on average, an
89.9% reduction in menstrual blood loss from baseline at Week 52.
Changes in bone mineral density through one year, as assessed by
DXA every three months, were consistent with LIBERTY 1 and 2. The
incidence of adverse events over one year was consistent with that
observed in LIBERTY 1 and 2, with no new safety signals
observed.
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,
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.
An estimated five million women in the U.S. suffer
from symptoms of uterine fibroids, and an estimated three 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 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 and for men. 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 Statements This 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
redefine care for women’s health and prostate cancer; the
statements and characterizations of data from the LIBERTY and
ovulation inhibition clinical studies; the potential of relugolix
combination therapy to offer women suffering from uterine fibroids
meaningful benefit in reduced distress due to bleeding, passing
blood clots, and pelvic pressure, as well as improvement in anemia;
the Company’s regulatory strategies; and the timing of any
potential regulatory filings and approvals in any indication.
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’ Annual Report on Form 10-K filed on May
18, 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. 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 and
Chief Financial Officer Myovant Sciences, Inc.
investors@myovant.com
Media Contact: Albert Liao Director,
Corporate Communications Myovant Sciences, Inc.
media@myovant.com
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