BASEL, Switzerland,
Nov. 9, 2017 /PRNewswire/
-- Myovant Sciences (NYSE: MYOV), a clinical-stage
biopharmaceutical company focused on women's health and endocrine
diseases, 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 for
the treatment of pain associated with uterine fibroids. Relugolix,
an oral once-daily gonadotropin-releasing hormone (GnRH) receptor
antagonist that rapidly lowers estrogen and progesterone in women,
is also being evaluated by Myovant in a Phase 3 clinical program
consisting of two international, replicate pivotal clinical trials
(LIBERTY 1 and LIBERTY 2) of relugolix in women with heavy
menstrual bleeding associated with uterine fibroids.
Takeda's Phase 3 trial primary endpoint was met with 57.6% of
women with uterine fibroids treated with relugolix demonstrating a
marked improvement in pain symptoms (maximum pain score of ≤ 1 on a
scale of 0 to 10) compared with 3.1% of women treated with placebo
(p < 0.0001). Adverse events in patients treated with
relugolix were consistent with the mechanism of action and adverse
events observed in previous studies.
"Two Phase 3 studies of relugolix conducted by Takeda have now
demonstrated significant benefit on the two most debilitating
symptoms suffered by women with uterine fibroids," stated
Juan Camilo Arjona Ferreira, M.D.,
Chief Medical Officer of Myovant Sciences. "Treatment with
relugolix significantly decreased heavy menstrual bleeding and now
pain associated with uterine fibroids, with the majority of women
in the current study experiencing little or no pain by the end of
the 12-week study."
Takeda's Phase 3 Program for Uterine Fibroids
This Phase 3 study was a multicenter, randomized, double-blind
placebo-controlled study conducted in Japan to evaluate the efficacy and safety of
relugolix in the treatment of pain symptoms associated with uterine
fibroids compared to placebo. Sixty-five patients were randomized
1:1 to receive either relugolix 40 mg, administered orally once
daily, or placebo for 12 weeks.
The primary endpoint was the proportion of women who achieved a
maximum score of 1 or less on the Numerical Rating Scale (NRS) for
pain associated with uterine fibroids during each of the 28 days
before the final dose. The NRS is a self-reported instrument
assessing pain on an 11-point scale as follows: 0 (no pain), 1-3
(mild pain), 4-6 (moderate pain), and 7-10 (severe pain). All
participants had a maximum NRS ≥ 4 upon entry into the study and
completed the scale each day using a diary while on the study. Of
the women treated with relugolix, 57.6% achieved the primary
endpoint compared to 3.1% in the placebo arm (p < 0.0001).
Common adverse events (≥10%) reported more frequently in patients
treated with relugolix relative to patients treated with placebo
included hot flush, metrorrhagia, hyperhidrosis and menorrhagia,
which are consistent with the mechanism of action and adverse
events observed in previous studies.
On October 2, 2017, Myovant
announced positive top-line results from Takeda's first Phase 3
study evaluating the efficacy and safety of relugolix compared to
leuprorelin for the treatment of heavy menstrual bleeding and
uterine fibroids. In that study, relugolix successfully
demonstrated non-inferiority to leuprorelin, with 82.2% of patients
treated with relugolix meeting the study's primary endpoint, which
was the proportion of patients achieving a pre-defined marked
reduction in menstrual bleeding, compared with 83.1% of patients
treated with leuprorelin (p = 0.0013). The incidence of adverse
events was generally similar between treatment groups and
consistent with the mechanism of action of the study
medications.
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's 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) of relugolix in women with heavy
menstrual bleeding associated with uterine fibroids. In these
studies, women are randomized in a 1:1:1 ratio to one of three arms
to 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 Takeda's Phase 3 studies differ from those in the
Phase 3 studies Myovant is currently conducting, the data from the
Takeda studies 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 over 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
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