- Results from six-month, Phase 2b safety and efficacy trial
show elagolix met composite primary efficacy endpoint
- Phase 3 program is targeted to begin the first quarter of
2016
NORTH CHICAGO, Illinois,
Sept. 16, 2015 /PRNewswire/ -- AbbVie
(NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc.
(NASDAQ: NBIX), today announced the completion of a Phase 2b
clinical trial evaluating the safety and efficacy of elagolix alone
or in combination with add-back therapy compared to placebo. The
trial was conducted in women with heavy menstrual bleeding (HMB)
associated with uterine fibroids. Preliminary results showed that
all of the elagolix treatment arms, with and without add-back
therapy, reduced heavy menstrual bleeding as compared to placebo
(p<0.001). The study's primary endpoint was a composite design
where subjects had to achieve a menstrual blood loss (MBL) volume
of less than 80 mL as well as a 50 percent or greater reduction in
MBL volume from baseline at the final study month as measured by
the alkaline hematin method.
Uterine fibroids (also called leiomyomas or myomas) are
noncancerous muscle tissue tumors of the uterus.1
Fibroids are most common in women aged 30-40 years but can occur at
any age.1 They can range in size from nearly
undetectable to bulky masses that can distort the
uterus.2 Fibroids can be asymptomatic but in some women
cause symptoms such as: longer, more frequent, or heavy menstrual
bleeding; menstrual pain; vaginal bleeding at time other than
menstruation; pain in the abdomen or lower back; pain during sex;
difficulty urinating; frequent urination; constipation or rectal
pain.1
"The positive results from this trial represent an important
milestone in the development of elagolix as a potential new
treatment option for women suffering from heavy menstrual bleeding
associated with uterine fibroids," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "Our clinical research with elagolix for the treatment of
uterine fibroids complements ongoing Phase 3 endometriosis
research. These two development programs demonstrate AbbVie's
continued commitment to therapeutic advances in women's
healthcare."
Among the most common adverse events (AEs) were hot flush,
headache, nausea, and vomiting. Some AEs such as hot flush were
more frequent in the elagolix only treatment arms as compared to
the placebo and elagolix with add-back therapy treatment arms.
Reduction in bone mineral density associated with elagolix alone
was attenuated when elagolix was co-administered with add-back
therapy. Discontinuations due to AEs were slightly greater for the
elagolix 600 mg once-daily (QD) treatment arms with and without
add-back therapy as compared to elagolix 300mg twice-daily (BID)
treatment arms with and without add-back therapy.
The Phase 3 program is targeted to begin the first quarter of
2016 and will include two replicate, pivotal, six-month efficacy
and safety studies followed by a six-month safety and efficacy
extension study. The primary endpoint in Phase 3 studies will be
the same as that employed in the Phase 2b study; percent of
subjects with reduction in uterine blood flow as measured by the
alkaline hematin method. Final results from this 2b trial will be
presented at a medical conference in the future. Elagolix Uterine
Fibroid Phase 2a data have been accepted for presentation at the
2015 Annual Meeting of the American Society of Reproductive
Medicine in Baltimore,
October 2015.
Trial Design
The Phase 2b trial (M12-813) is a
24-week, randomized, double-blind, multicenter, placebo-controlled,
two cohort‑design study that evaluates the safety and efficacy of
two different elagolix treatment regimens (300 mg BID and 600 mg
QD) alone and in combination with two different strengths of
add-back therapy (estradiol/norethindrone acetate). It was
conducted in approximately 567 premenopausal women, age 18 to 51,
with HMB associated with uterine fibroids, at approximately 100
sites in the United States,
Canada, Puerto Rico, Chile, and the United Kingdom.
About Elagolix
Elagolix is an oral agent currently
being investigated for the inhibition of gonadatropin releasing
hormone (GnRH) receptors in the pituitary gland which ultimately
reduces circulating sex hormone levels. To date, elagolix has been
studied in over 40 clinical trials totaling more than 3,000
subjects. Phase 3 trials of elagolix for the management of
endometriosis-associated pain are also ongoing.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott Laboratories. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most
complex and serious diseases. Together with its wholly-owned
subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people
worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com. Follow @abbvie on Twitter
or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this
news release may be forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995. The words
"believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2014 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
1American Congress of Obstetricians and
Gynecologists. Frequently Asked Questions about Gynecologic
Problems Uterine Fibroid Fact Sheet.
http://www.acog.org/Patients/FAQs/Uterine-Fibroids. Accessed
September 12, 2015.
2 Mayo Clinic. Diseases and Conditions: Uterine
Fibroids.
http://www.mayoclinic.org/diseases-conditions/uterine-fibroids/basics/symptoms/con-20037901.
Accessed September 12, 2015.