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 it has
completed patient recruitment for its SPIRIT 2 study, the first of
two Phase 3 replicate studies evaluating relugolix combination
therapy in women with endometriosis-associated pain. The SPIRIT 2
study is part of an international clinical development program
designed to gain regulatory approval of relugolix for the treatment
of moderate-to-severe endometriosis-associated pain.
“One in ten premenopausal women have endometriosis, a condition
often associated with debilitating pain, that is particularly
severe during menstruation, and infertility. Currently, the
standard of care for women with moderate to severe endometriosis is
invasive procedures and pain medicines, including opioids, which
have significant limitations. We are developing relugolix
combination therapy as a single pill taken once a day with the goal
of offering patients a well-tolerated and effective alternative,”
said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of
Myovant Sciences. “With the completion of recruitment, we are on
track to report top-line data for SPIRIT 2 in the first quarter of
2020, and data from our replicate study, SPIRIT 1, in the second
quarter.”
About Myovant's Phase 3 Program for
Endometriosis
Myovant is currently conducting a Phase 3 clinical program
consisting of two international, replicate pivotal clinical studies
(SPIRIT 1 and SPIRIT 2) of relugolix combination therapy in women
with endometriosis-associated pain. Each of the SPIRIT studies is
enrolling approximately 600 women 18 to 50 years of age with a
diagnosis of endometriosis confirmed by laparoscopy or laparotomy.
Eligible women are randomized to one of three groups: relugolix
combination therapy (relugolix 40 mg plus estradiol 1.0 mg and
norethindrone acetate 0.5 mg) 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 are evaluating the impact of treatment
on menstrual pelvic pain or dysmenorrhea and on 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 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 developing relugolix combination therapy
(relugolix 40 mg plus 1.0 mg estradiol with 0.5 mg norethindrone
acetate) for women with heavy menstrual bleeding associated with
uterine fibroids and for endometriosis-associated pain.
Myovant announced results from two successful Phase 3 clinical
studies evaluating relugolix combination therapy in women with
heavy menstrual bleeding and uterine fibroids. The company expects
to submit a New Drug Application (NDA) to the FDA in the fourth
quarter of 2019 for this indication. Top-line results from
Myovant’s two Phase 3 studies evaluating women with
endometriosis-associated pain are expected in the first and second
quarters of 2020.
Relugolix monotherapy, 120 mg once daily, lowers testosterone in
men and is being evaluated in a Phase 3 HERO study in men with
advanced prostate cancer. Top-line results from the HERO study are
expected in the fourth quarter of 2019.
About Myovant Sciences
Myovant Sciences aspires to be the leading healthcare
company focused on innovative treatments for women’s health and
prostate cancer. Myovant Sciences’ lead product candidate is
relugolix, an oral, once-a-day small molecule that acts as a GnRH
receptor antagonist. Myovant Sciences has three
late-stage clinical programs for relugolix ongoing in uterine
fibroids, endometriosis and prostate cancer. Myovant
Sciences 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 Sciences 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 Sciences intends
to expand its development pipeline to include other potential
treatments for women’s health and prostate cancer. For more
information, please visit Myovant Sciences’ website
at www.myovant.com. Follow @Myovant on Twitter and LinkedIn
(https://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 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, Myovant
Sciences’ intentions to expand its development pipeline to include
other potential treatments for women’s health and prostate cancer
and Myovant Sciences’ plans to report the results from its two
Phase 3 endometriosis studies in the first and second quarters of
calendar year 2020.
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
Officer Myovant Sciences, Inc. investors@myovant.com
Media Contact: Sheryl Seapy Pure Communications
sseapy@purecommunications.com 949.903.4750
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