BASEL, Switzerland,
May 24, 2017 /PRNewswire/
-- Myovant Sciences (NYSE: MYOV) today announced the
presentation of data from a Phase 2 extension study conducted by
Takeda Pharmaceutical Company Ltd. ("Takeda") evaluating relugolix
in Japanese women with endometriosis-associated pain. Oral,
once-daily treatment with relugolix (10, 20, or 40 mg) was
generally well tolerated during the 24 weeks comprising the initial
12-week study and the 12-week extension study. Treatment-emergent
adverse events for patients receiving relugolix, such as hot flush
and menorrhagia, were consistent with the drug's mechanism of
action.
Efficacy outcomes for the full 24-week period were consistent
with outcomes during the initial 12-week trial, with greater
dose-dependent reductions in overall pelvic pain, dysmenorrhea, and
non-menstrual pelvic pain seen in the relugolix treatment arms
compared to placebo. The largest decrease was seen in the relugolix
40-mg group throughout the treatment period, and the reductions in
the mean Visual Analogue Scale (VAS) score from baseline for
overall pelvic pain, dysmenorrhea, and non-menstrual pelvic pain in
the relugolix 40-mg group were similar to those in an active
reference group receiving monthly injections of leuprorelin. The
findings were presented during a poster presentation on
May 23 at the 2017 European Congress
of Endocrinology in Lisbon, Portugal.
Long-Term Extension Study Results
Of the 484 patients randomized and administered study drug in
the initial 12-week study, 397 (82%) were enrolled in the extension
study, and 373 (94% of enrolled patients) completed the treatment
period for the extension study. There were no clinically relevant
differences in the demographic and baseline characteristics of the
treatment groups.
The incidence of mild and moderate adverse events in the
relugolix 20- and 40-mg groups was higher than that observed in the
placebo group, and comparable to that observed in an active
reference group receiving monthly injections of leuprorelin. The
most commonly observed adverse events (occurring in at least 10% of
patients in the relugolix groups and greater in the relugolix than
placebo groups) were primarily mild or moderate in severity and
included irregular or heavy menstrual bleeding (metrorrhagia,
menorrhagia, irregular menstruation), sweating (hyperhidrosis), and
hot flush.
Bone mineral density decreased in a time- and dose-dependent
fashion in the relugolix groups with the greatest losses (mean
percent change from baseline) after 24 weeks observed in the
relugolix 40-mg group (-4.9%), as compared with the placebo group
(-0.2%) and the leuprorelin group (-4.4%). The menstruation
recovery period was 21 to 37 days after the last dose in the
relugolix groups; the recovery period in the leuprorelin group was
73 days.
Reductions in mean VAS score from baseline for overall pelvic
pain, dysmenorrhea, and non-menstrual pelvic pain in the relugolix
groups were dose-dependent, with the largest decreases in the
relugolix 40-mg group throughout the treatment period. Pain
intensity was assessed using a 100 millimeter (mm) VAS in which 0
mm indicated "No pain" and 100 mm indicated "Pain as bad as you can
imagine." Scores were reported daily in patient diaries.
The mean reduction in overall pelvic pain for the relugolix
40-mg group at the end of the extension study was -11.9 mm from
baseline (15.3 mm), compared to a mean reduction of -3.2 mm in the
placebo arm from baseline (15.6 mm). The reduction achieved by
relugolix, 40 mg orally once daily, was comparable to that observed
in the active control arm of patients receiving monthly injections
of leuprorelin.
For pain during menses, or dysmenorrhea, the relugolix 40-mg
group achieved a mean reduction of -29.5 mm at the end of extension
study from baseline (30.4 mm) compared to a mean reduction of -5.8
mm in the placebo group from baseline (28.4 mm). No clear trend was
observed in mean VAS scores from baseline across the dosing groups
for dyspareunia with a trend for lower scores over time for the
relugolix 40 mg and leuprorelin groups.
The proportion of patients reporting no pain in the VAS score
for overall pelvic pain at the end of the treatment period were 0%
for placebo, 7% for relugolix 10 mg, 20% for relugolix 20 mg, 50%
for relugolix 40 mg, and 57% for leuprorelin.
"The findings in the long-term extension study offer additional
support for our upcoming Phase 3 studies evaluating relugolix
co-administered with low-dose hormonal add-back therapy in women
with endometriosis-associated pain," said Lynn Seely, MD, President & Chief Executive
Officer of Myovant Sciences. "We look forward to initiating those
studies and advancing the development of relugolix in the months to
come."
Long-Term Extension Study Design
The Phase 2 multicenter, randomized, parallel-group,
placebo-controlled long-term extension study conducted by Takeda
was designed to evaluate the safety and efficacy of relugolix
administered orally at a dose of 10, 20, or 40 mg once daily for a
full 24 weeks in premenopausal Japanese women, 20 years of age or
older, with a diagnosis of both endometriosis and
moderate-to-severe dysmenorrhea or pelvic pain who participated in
a prior double-blind, 12-week study. The study also included an
active reference group that received monthly injections of
leuprorelin.
The prior Phase 2 study consisted of a 4- to 12-week
pretreatment period with a placebo run-in period that was initiated
during the first menstrual cycle; after completion of the
pretreatment period patients were randomly assigned to either a
relugolix treatment group, an injectable leuprorelin group, or
placebo for a 12-week treatment period. Upon completion of that
treatment period, eligible participants were offered the
opportunity to enter the 12-week extension study. Patients in the
extension study were assigned to the same treatment groups as the
preceding Phase 2 study.
The study's primary outcome was assessment of safety, including
bone mineral density, adverse events, vital signs, weight, 12-lead
electrocardiograms, and clinical laboratory tests. The secondary
endpoint was an assessment of efficacy through 24 weeks including
VAS scores for overall pelvic pain, dysmenorrhea, and dyspareunia
at the end of treatment. Additional endpoints included
endometriosis-associated pain symptoms assessed by physician
Biberoglu & Behrman (B & B) scores and modified patient B
& B scores, use of analgesics during the treatment period,
decrease in menstrual blood loss and achievement of amenorrheic
state, and quality of life and symptom severity as assessed by
long-form 30-item EHP-30 scores.
About Relugolix
Relugolix is an oral, once-daily, small molecule
gonadotropin-releasing hormone (GnRH) receptor antagonist and has
been evaluated in over 1,300 study participants in Phase 1 and
multiple large controlled Phase 2 clinical trials. In these trials,
relugolix was generally well tolerated and suppressed estrogen and
progesterone levels in women and testosterone levels in men. Common
side effects of relugolix are consistent with its mechanism of
action in lowering these sex hormones.
Myovant Sciences has an exclusive, worldwide license
(excluding Japan and certain other Asian countries) to
develop and commercialize relugolix. Myovant is developing
relugolix as an oral, once-daily, GnRH receptor antagonist for
heavy menstrual bleeding associated with uterine fibroids,
endometriosis-associated pain, and advanced prostate cancer.
About Endometriosis
Endometriosis is a disease in which tissue that normally lines
the uterus is found outside the uterine cavity, commonly in the
lower abdomen or pelvis, on ovaries, the bladder, and the colon.
This tissue outside the uterus results in chronic inflammation and
can cause scarring and adhesions. The symptoms associated with
endometriosis include painful periods and chronic pelvic pain,
painful ovulation, pain during or after sexual intercourse, heavy
bleeding, fatigue, and infertility. Endometriosis can also impact
general physical, mental, and social well-being. For
endometriosis-associated pain, initial treatment options include
oral contraceptives and over-the-counter pain medications. In more
severe cases, GnRH agonists such as leuprorelin are used for
short-term treatment. It is estimated that approximately 6 million
women in the United States suffer
from symptomatic endometriosis, 1.2 million of whom are
inadequately treated by oral contraceptives and require additional
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 GnRH
receptor antagonist. Myovant has initiated a Phase 3 clinical
program, consisting of two international clinical trials, LIBERTY 1
and LIBERTY 2, for relugolix in women with heavy menstrual bleeding
associated with uterine fibroids, as well as a Phase 3 clinical
program, HERO, for relugolix in men with advanced prostate cancer.
Myovant plans to initiate an additional Phase 3 clinical program
for relugolix in women with endometriosis-associated pain in the
second quarter of 2017. Myovant is simultaneously developing
MVT-602, an analog of kisspeptin, for the treatment of female
infertility as part of assisted reproduction. 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 myovant.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding Myovant's plans to advance the
clinical development of its product candidates and expand its
development pipeline. Forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ
materially from those anticipated by the forward-looking
statements. These risks and uncertainties include, but are not
limited to, risks associated with the success, cost, and timing of
the company's product development activities and clinical trials.
For further information regarding risks and uncertainties that
could cause actual results to differ from those anticipated by
these forward-looking statements, as well as risks relating to
Myovant's business in general, see the "Risk Factors" section of
Myovant's quarterly report on Form 10-Q filed with the Securities
and Exchange Commission (SEC) on February
13, 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.
Media Contact:
Julie Normart
Pure Communications
jnormart@purecommunications.com
415.946.1087
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SOURCE Myovant Sciences