Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare
company focused on developing and commercializing innovative
therapies for women’s health and prostate cancer, today announced
that LIBERTY 2, the second of two Phase 3 studies of once-daily
relugolix combination therapy, met its primary efficacy endpoint
and six key secondary endpoints in women with uterine fibroids. In
addition, relugolix combination therapy maintained bone mineral
density at levels comparable to placebo over 24 weeks and was
generally well- tolerated. These results confirm the previously
announced data from the Phase 3 LIBERTY 1 study and enable an NDA
submission to the U.S. Food and Drug Administration (FDA) by the
end of this year.
Myovant Sciences also announced that a separate clinical study
of single-tablet relugolix combination therapy met all required and
pre-specified FDA criteria for bioequivalence, providing critical
data necessary to include the once-daily, single-tablet regimen in
the NDA submission for approval of the treatment for uterine
fibroids. The single-tablet regimen is the formulation intended to
be offered to women should relugolix combination therapy receive
FDA approval.
“Millions of women suffer from heavy bleeding, pain, anemia,
lost productivity, or pregnancy complications resulting from
uterine fibroids,” said Andrea Lukes, MD, MHSc, Founder of the
Carolina Women’s Research and Wellness Center and LIBERTY Program
Steering Committee Member. “The data from the two pivotal LIBERTY
studies suggest we have a medicine that could offer meaningful
improvement in symptoms without sacrificing safety and
tolerability. Relugolix combination therapy has the potential to
transform the treatment paradigm for women by offering them a
well-tolerated, elegant oral alternative to the surgical or less
effective treatment options available today.”
“Myovant Sciences has now clearly demonstrated in two, large,
late-stage studies and a separate, positive bioequivalence study
that relugolix combination therapy has a distinctive constellation
of attributes, including substantial symptom relief with a
well-tolerated safety profile, all in a single pill that can be
taken once a day. No one else has achieved this for women with
uterine fibroids,” said Lynn Seely, MD, President and CEO of
Myovant Sciences. “With these results, our team is focused on
submitting the NDA by the end of the year and continuing to build
the organization and capabilities to efficiently and successfully
deliver this treatment to women in need.”
In the primary endpoint analysis of LIBERTY 2, 71.2% of women
receiving once-daily relugolix combination therapy achieved the
responder criteria compared with 14.7% of women receiving placebo
(p < 0.0001). 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. On average,
women receiving relugolix combination therapy experienced a highly
significant 84.3% reduction in menstrual blood loss from baseline
(p < 0.0001). In addition, a significantly greater proportion of
women suffering from moderate-to-severe pain from uterine fibroids
at baseline experienced no pain or minimal pain during the last 35
days of treatment with relugolix combination therapy compared with
women on placebo (p < 0.0001).
Changes in bone mineral density were comparable between the
relugolix combination and placebo groups at the end of treatment.
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).
Six key secondary endpoints achieved statistical significance
compared to placebo, consisting of mean change in menstrual blood
loss from baseline to week 24, reduction in pain in women with pain
at baseline, improvement in quality of life, amenorrhea, defined as
no or negligible blood loss, improvement in anemia in those women
with anemia at baseline (all p-values < 0.0001), and reduction
in uterine volume (p = 0.008).
The overall incidence of adverse events in the relugolix
combination and placebo groups was comparable (60.3% vs.
58.9%). In the relugolix combination therapy group, 1.6% of
women discontinued treatment early due to adverse events compared
with 4.7% in the placebo group. There were no adverse events in the
relugolix combination group reported by at least 10% of women and
more frequently than in the placebo group. The incidence of hot
flashes in the relugolix combination group was similar to placebo
(5.6% versus 3.9%). There were no pregnancies in the relugolix
combination group and one in the placebo group.
Conference Call Myovant Sciences will
hold a conference call today, July 23, 2019 beginning
at 8:30 a.m. EDT / 5:30 a.m. PDT. The dial-in
numbers are 1-800-532-3746 for domestic callers and 1-470-495-9166
for international callers. A live webcast of the conference call
will also be available on the investor relations page of Myovant
Sciences’ website at investors.myovant.com. After the live webcast,
the event will remain archived on Myovant Sciences’ website for at
least 30 days.
Phase 3 LIBERTY Program in Uterine Fibroids
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.
In LIBERTY 1, 73.4% of women receiving once daily oral relugolix
combination therapy achieved the responder criteria compared with
18.9% of women receiving placebo (p < 0.0001). On average, women
receiving relugolix combination therapy experienced an 84.3%
reduction in menstrual blood loss from baseline (p < 0.0001) as
well as a significant improvement in pain (p < 0.0001) and
measures of quality of life (p < 0.0001). In LIBERTY 1, the
safety profile observed with relugolix combination therapy was
generally similar to placebo including comparable changes in bone
mineral density between the relugolix combination and placebo
groups.
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,
to evaluate the need for maintenance therapy.
Bioequivalence StudyThe bioequivalence study
was conducted to establish the bioequivalence of a single tablet
containing relugolix 40 mg, estradiol 1.0 mg, and norethindrone
acetate 0.5 mg with the co-administered regimen used in the LIBERTY
clinical program (one relugolix 40 mg tablet and one tablet
containing estradiol 1.0 mg and norethindrone acetate 0.5 mg).
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 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 production, a hormone known to stimulate
the growth of uterine fibroids. Myovant is also studying relugolix
combination therapy (relugolix 40 mg plus 1.0 mg estradiol with 0.5
mg norethindrone acetate) 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 a Phase
3 HERO study in men with advanced prostate cancer.
About Myovant Sciences Myovant
Sciences aspires to be the leading healthcare company focused
on innovative treatments for women's health and prostate cancer.
Myovant’s lead product candidate is relugolix, an oral once-daily
small molecule that acts as a GnRH receptor antagonist. Myovant has
three late-stage clinical programs for relugolix ongoing in uterine
fibroids, endometriosis and prostate cancer. Myovant 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 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. Over time, Myovant intends to expand its
development pipeline to include other potential treatments for
women's health and prostate cancer. For more information, please
visit Myovant's website at www.myovant.com. Follow @Myovant on
Twitter and LinkedIn
(https://www.linkedin.com/company/myovant-sciences).
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 that are not historical
statements of fact and statements regarding the Company’s intent,
belief, or expectations and can be identified by words such as
"aspire, “anticipate," "believe," "can," "could," "expect,"
"intend," "likely," "may," "might," "plan," "potential," "project,"
"should," "will," "would," or the negative or plural of these
words, although not all forward-looking statements contain these
identifying words. In this press release, forward-looking
statements include, but are not limited to, statements regarding
the Company’s aspirations to become the leading healthcare company
focused on innovative treatments for women's health and prostate
cancer, the Company’s intentions to expand its development pipeline
to include other potential treatments for women’s health and
prostate cancer, the Company’s plans to file for approval of
relugolix combination therapy, including with a once daily single
tablet, and for long-term use, the timing of such filing, the
likelihood of approval, and the commercial potential for relugolix,
including market size.
The Company’s 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 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 the Company’s 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 the Company’s filings with the United States Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in the Company’s Annual Report on Form 10-K filed with
the SEC on May 24, 2019, as such risk factors may be
amended, supplemented or superseded from time to time by other
reports the Company files with the SEC. These risks are not
exhaustive. New risk factors emerge from time to time and it
is not possible for the Company’s management to predict all risk
factors, nor can Myovant 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, the Company undertakes no obligation to update
these forward-looking statements to reflect events or circumstances
after the date of such statements.
Investor Contact: Frank Karbe Chief Financial
Officer Myovant Sciences, Inc. investors@myovant.com
Media Contact: Sheryl Seapy Pure Communications
sseapy@purecommunications.com 949.903.4750
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