BASEL, Switzerland,
Oct. 2, 2017 /PRNewswire/
-- Myovant Sciences (NYSE: MYOV) today announced that
Takeda Pharmaceutical Company Limited ("Takeda") has reported
positive top-line results from a Phase 3 study evaluating the
efficacy and safety of relugolix compared with leuprorelin for the
treatment of uterine fibroids in Japanese women. Relugolix
was statistically non-inferior to leuprorelin (p = 0.0013) meeting
the study's primary endpoint, the proportion of patients achieving
a pre-defined reduction in menstrual bleeding.
Myovant is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapies for women's
health and endocrine diseases with relugolix as its lead product
candidate. Relugolix, an oral gonadotropin-releasing hormone
(GnRH) receptor antagonist, rapidly lowers estrogen and
progesterone in women when administered orally once-daily.
The incidence of adverse events in the Phase 3 study was generally
similar between treatment groups and consistent with the mechanism
of action of the study medications.
"The positive results of decreased menstrual bleeding from
Takeda's Phase 3 study of relugolix in Japanese women with uterine
fibroids provides strong support for Myovant's ongoing Phase 3
studies with relugolix in North
America, Europe and other
regions," stated Lynn Seely, M.D.,
President and Chief Executive Officer of Myovant Sciences.
"Uterine fibroids result in debilitating heavy menstrual bleeding
and anemia in millions of women throughout the world, oftentimes
requiring a hysterectomy to control the bleeding. Myovant is
working to develop relugolix, an oral, once-daily medication that
can potentially provide women with an alternative option to major
surgery for the treatment of uterine fibroids."
Takeda Phase 3 Study Design and Results
The Phase 3 trial was a multicenter, randomized, double-blind
non-inferiority study conducted in Japan to evaluate the efficacy and safety of
relugolix in approximately 280 women with heavy menstrual bleeding
associated with uterine fibroids. Patients were randomized
1:1 to receive either relugolix 40 mg, administered orally once
daily, or leuprorelin, administered by subcutaneous injection every
four weeks, at a dose of 1.88 mg or 3.75 mg, for 24 weeks.
Leuprorelin, or leuprolide acetate, is an injectable GnRH agonist
approved for pre-operative treatment of uterine fibroids in
Japan.
The primary endpoint was the proportion of women who achieved a
total score of less than 10 on the Pictorial Blood Loss Assessment
Chart, or PBAC, a patient-reported outcome measure for evaluation
of menstrual blood loss in clinical trials, from week 6 to week
12. All participants had a PBAC ≥ 120 upon entry into the
study. In the study, relugolix successfully demonstrated
non-inferiority to leuprorelin with 82.2% of patients treated with
relugolix achieving a score of less than 10 on the PBAC, compared
with 83.1% of patients treated with leuprorelin (p = 0.0013).
The incidence of adverse events in the Phase 3 study was generally
similar between treatment groups and consistent with the mechanism
of action of the study medications.
Takeda is conducting a second Phase 3 trial evaluating relugolix
in approximately 70 Japanese women who have pain associated with
uterine fibroids and anticipates preliminary top-line data in the
fourth quarter of 2017. Takeda plans to submit the data from
both studies to regulatory authorities in Japan for marketing authorization of relugolix
for the treatment of uterine fibroids.
Myovant Phase 3 Program for Uterine Fibroids
Myovant is currently conducting a Phase 3 clinical program
consisting of two international, replicate pivotal clinical trials
(LIBERTY 1 and LIBERTY 2), initiated in January 2017, of relugolix in women with heavy
menstrual bleeding associated with uterine fibroids. Women with
heavy menstrual bleeding associated with uterine fibroids in the
LIBERTY 1 and LIBERTY 2 trials are randomized in a 1:1:1 ratio to
one of three arms. Women receive treatment with relugolix 40 mg
once daily co-administered with commercially available low-dose
hormonal add-back therapy for 24 weeks, relugolix 40 mg once daily
monotherapy for 12 weeks followed by relugolix 40 mg once daily
co-administered with hormonal add-back therapy for an additional 12
weeks, or placebo once daily for a period of 24 weeks.
Approximately 390 women are targeted to be enrolled in each of the
two replicate LIBERTY 1 and LIBERTY 2 trials, with 130 women in
each of the two active treatment arms and 130 women in the placebo
arm. To be enrolled, women must have a monthly menstrual
blood loss of at least 80 mL, measured by the alkaline hematin
method, a quantitative measure of menstrual blood loss.
The primary efficacy endpoint for LIBERTY 1 and LIBERTY 2 is the
proportion of all women enrolled who achieve a menstrual blood loss
volume of less than 80 mL and at least a 50% reduction in menstrual
blood loss volume from baseline over the last month of treatment as
measured by the alkaline hematin method. The secondary efficacy
endpoints include measures of change from baseline in hemoglobin,
assessment of the impact of therapy on quality-of-life measures,
the reduction in uterine and fibroid volume, and pain reduction.
Safety, including bone mineral density changes as measured by
dual-energy x-ray absorptiometry, is also being assessed.
Eligible women completing the LIBERTY 1 or LIBERTY 2 trial will
be offered the opportunity to enroll in an active treatment
extension study where all patients will receive relugolix 40 mg
once daily co-administered with hormonal add-back therapy for an
additional 28-week period, for a total treatment period of 52
weeks, to evaluate the safety and durability of efficacy of
long‑term treatment.
Myovant is solely responsible for obtaining Food and Drug
Administration (FDA) approval for relugolix in the United
States. While the trial design and endpoints of the Takeda
Phase 3 study differ from those in the Phase 3 studies Myovant is
currently conducting, the data from the Takeda study are expected
to be used to support Myovant's New Drug Application (NDA) for
relugolix in the United States and
other geographic regions.
About Relugolix
Relugolix is an oral, once-daily, small molecule GnRH receptor
antagonist that has been evaluated in almost 1,600 study
participants in Phase 1, Phase 2 and Phase 3 clinical trials. In
these trials, relugolix has been shown to be generally well
tolerated and to suppress estrogen and progesterone levels in women
and testosterone levels in men. Common side effects are consistent
with suppression of these hormones. In the ongoing Phase 3 SPIRIT
clinical trials in women with endometriosis-associated pain and the
ongoing Phase 3 LIBERTY clinical trials in women with heavy
menstrual bleeding associated with uterine fibroids, relugolix will
be evaluated with and without low-dose hormonal add-back therapy,
the addition of which is expected to decrease potential side
effects such as bone mineral density loss and hot flashes. The
ongoing Phase 3 HERO study is evaluating relugolix in men with
advanced prostate cancer.
About Uterine Fibroids
Uterine fibroids are noncancerous tumors composed of smooth
muscle and fibrous connective tissue that develop in or on the
walls of the uterus. 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 that are often asymptomatic, 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. Uterine
fibroids are among the most common reproductive tract tumors in
women. It is estimated that approximately 5 million women in
the United States suffer from
symptoms of uterine fibroids, approximately 3 million of whom are
inadequately treated by current medical therapy and require further
treatment.
About Myovant Sciences
Myovant Sciences is a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative therapies for
women's health and endocrine diseases. Myovant's lead product
candidate is relugolix, an oral, once-daily, small molecule that
acts as a GnRH receptor antagonist. Myovant has initiated three
clinical programs for relugolix consisting of five international
Phase 3 clinical trials, two in women with heavy menstrual bleeding
associated with uterine fibroids (LIBERTY 1 & 2), two in women
with endometriosis-associated pain (SPIRIT 1 & 2), and one in
men with advanced prostate cancer (HERO). Myovant is simultaneously
developing MVT- 602, a kisspeptin agonist, for the treatment of
female infertility as part of assisted reproduction. Takeda
Pharmaceuticals International AG has granted Myovant an exclusive,
worldwide license to develop and commercialize relugolix (excluding
Japan and certain other Asian
countries where Takeda retains exclusive rights) and an exclusive
license to develop and commercialize MVT-602 in all countries
worldwide. Over time, the company intends to expand its
development pipeline to include other potential treatments for
women's health and endocrine diseases. For more information, please
visit the company's website at www.myovant.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding Myovant's plans for the development
of its pipeline and completion of its clinical studies.
Forward-looking statements can be identified by the words
"believe," "anticipate," "continue," "estimate," "project,"
"expect," "plan," "potential," "intends," "will," "would," "could,"
"should" or the negative or plural of these words or other similar
expressions that are predictions or indicate future events, trends
or prospects. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
and reported results should not be considered as an indication of
future performance. These risks and uncertainties include, but are
not limited to: risks associated with the success, cost and timing
of our product development activities and clinical trials,
increased regulatory requirements, and interim results or other
preliminary analyses do not ensure that later or final results in a
clinical trial or in related or similar clinical trials will
replicate those interim results. There can be no assurance that any
of our product candidates will ever receive regulatory approval or
be successfully commercialized.
For a further description of the risks and uncertainties that
could cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to Myovant's
business in general, see the "Risk Factors" section of our
quarterly report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on August 10,
2017, and other filings that Myovant makes with the SEC from
time to time. These forward-looking statements are based on
information available to Myovant as of the date of this press
release and speak only as of the date of this release. Myovant
disclaims any obligation to update these forward-looking
statements, except as may be required by law.
Contacts:
Investors
DeDe Sheel
Director, Investor Relations
Myovant Sciences, Inc.
650.457.1679
Media
Julie Normart
Pure Communications
jnormart@purecommunications.com
415.946.1087
View original content with
multimedia:http://www.prnewswire.com/news-releases/myovant-sciences-announces-positive-top-line-results-from-takedas-phase-3-study-evaluating-the-efficacy-and-safety-of-relugolix-compared-with-leuprorelin-for-the-treatment-of-uterine-fibroids-300529551.html
SOURCE Myovant Sciences