Myovant
Sciences (NYSE: MYOV), a
healthcare company focused on developing innovative treatments for
women's health and prostate cancer, today announced that it has
completed patient recruitment for its SPIRIT 1 study, the second of
two Phase 3 replicate studies evaluating relugolix combination
therapy in women with endometriosis-associated pain.
“The completion of recruitment for the SPIRIT program marks
another important step in achieving our goal to bring a
best-in-class, non-invasive treatment option to women suffering
from endometriosis, that has predictable efficacy and tolerability
and is potentially suitable for long-term use,” said Juan
Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant
Sciences. “We are extremely appreciative of the physicians and
patients who participate in our clinical trials and have helped us
reach this important milestone. We look forward to sharing the
top-line results in the first and second quarters of
2020.”
About the Phase 3 SPIRIT Program Myovant
Sciences’ Phase 3 clinical program for endometriosis consists of
two multinational, replicate pivotal clinical studies (SPIRIT 1 and
SPIRIT 2) of relugolix combination therapy (relugolix 40 mg plus
estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with
endometriosis-associated pain. Each of the SPIRIT studies was
designed to enroll approximately 600 women 18 to 50 years of age
with a diagnosis of endometriosis confirmed by laparoscopy or
laparotomy. Eligible women have been randomized to one of three
groups: relugolix combination therapy for 24 weeks, relugolix 40 mg
monotherapy for 12 weeks followed by relugolix combination therapy
for an additional 12 weeks, or placebo for a period of 24
weeks.
The co-primary endpoints evaluate the impact of treatment on
menstrual pelvic pain, or dysmenorrhea, and non-menstrual pelvic
pain. Safety outcomes, including bone mineral density changes as
measured by dual-energy x-ray absorptiometry, are also being
assessed.
Eligible patients completing the initial 24-week blinded
assessment will be offered an active treatment extension with
relugolix combination therapy for an additional 80-week period,
resulting in a total treatment period of up to 104 weeks, to
evaluate the safety of longer-term treatment.
About Endometriosis Endometriosis is a disease
in which tissue similar to the uterine lining is found outside the
uterine cavity, commonly in the lower abdomen or pelvis, on
ovaries, the bladder, and the colon. This endometrial-like 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 leuprolide acetate are
used for short-term treatment. An estimated six million women in
the U.S. suffer from symptoms of endometriosis, and an estimated
one million women are inadequately treated by current medical
therapy and require further treatment.
About RelugolixRelugolix 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. Myovant Sciences
is developing a relugolix combination tablet (relugolix 40 mg plus
estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with
heavy menstrual bleeding associated with uterine fibroids and for
women with endometriosis-associated pain. Myovant is also
evaluating relugolix monotherapy (120 mg once daily) in men with
advanced prostate cancer.
About Myovant SciencesMyovant
Sciences aspires to be the leading healthcare company focused
on innovative treatments for women’s health and prostate cancer.
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 granted the company 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. For more information, please visit the
company’s website at www.myovant.com. Follow @Myovant on
Twitter and LinkedIn.
Forward-Looking StatementsThis 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 regarding Myovant Sciences’ aspirations to become the
leading healthcare company focused on innovative treatments for
women’s health and prostate cancer, the expected timing for
announcing top-line results for SPIRIT 2 and SPIRIT 1 and whether
the studies will support regulatory submission for a single tablet,
once-daily treatment of moderate-to-severe endometriosis-associated
pain. 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’ Quarterly Report on Form 10-Q filed on
August 6, 2019, 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 and it is not
possible for Myovant Sciences’ management to predict all risk
factors, nor can Myovant Sciences 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, 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 Chief Financial
OfficerMyovant Sciences, Inc. investor@myovant.com
Media Contact: Albert LiaoDirector, Corporate
Communications Myovant Sciences, Inc. media@myovant.com
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