Repros Provides Phase 2 Results Showing Positive Outcomes for Oral Proellex® in Women With Moderate to Severe Endometriosis
September 07 2016 - 3:01PM
Repros Therapeutics Inc.® (Nasdaq:RPRX) today provided the results
of the first course of treatment from Repros’ ongoing study of
Proellex® for the treatment of premenopausal women with confirmed
symptomatic endometriosis.
The study was a Phase 2, double-blind study of oral Proellex®
(telapristone acetate) in a population of women with moderate to
severe confirmed endometriosis defined as a baseline BBSS Score
(Biberoglu and Behrman Symptom Score) of 7 or greater. Subjects
were randomized to 6 or 12 mg of Proellex® or placebo in a 1:1:1
fashion. A course of treatment lasted 18 weeks and was followed by
an Off Drug Interval. Subjects kept daily diaries recording
assessments of pain, menstrual bleeding and analgesic use.
The study randomized 60 subjects, 13 in Argentina and 47 in the
US. The subjects’ mean age was 30 years. As anticipated, 70% of
subjects treated with Proellex® became amenorrheic. The induction
of amenorrhea was associated with a substantial reduction in
reported pain and subsequent reduction in analgesic use. Responses
were similar across the two doses of Proellex® and are reported
here pooled.
Subjects assessed menstrual and non-menstrual pain daily during
baseline and treatment. The median percentage change from baseline
in the patient BBSS assessment of menstrual pain showed that
subjects improved with an 85.4% reduction in baseline score (p <
0.0001). In addition, despite evidence of a placebo response,
subjects treated with Proellex® had a statistically significant
greater reduction in menstrual pain compared to the 37.5% change
from baseline achieved with placebo (p = 0.0008). Although
non-menstrual pelvic pain was also reduced with treatment, a
difference between treatment groups could not be detected.
Encouragingly, the improvement in menstrual pain translated to a
reduction in the use of analgesics. During this first course of
treatment, subjects treated with Proellex® experienced a 56%
reduction in total pill count while placebo-treated subjects’ pill
use declined by 30% (p = 0.0521). The reduction in non-prescription
use was most striking: Proellex®-treated subjects had a 74%
reduction while placebo-treated subjects only experienced a
reduction of 11% (p = 0.0423).
Treatment with Proellex® was generally well tolerated.
Given these results, the Company is preparing to interact with
the FDA to discuss plans for late stage development of Proellex®
and Phase 3 studies to treat women who struggle with painful
menses.
About Repros Therapeutics Inc.®
Repros Therapeutics focuses on the development
of small molecule drugs for major unmet medical needs that treat
male and female reproductive disorders.
Forward-Looking Statements
Any statements made by the Company that are not
historical facts contained in this release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and are subject to various risks, uncertainties
and other factors that could cause the Company’s actual results,
performance or achievements to differ materially from those
expressed or implied by such forward-looking statements. These
statements often include words such as “may,” “will,” “expect,”
“anticipate,” “continue,” “estimate,” “project,” “intend,”
“believe,” “plan,” “seek,” “could,” “can,” “should” or similar
expressions. These statements are based on assumptions that the
Company has made in light of the Company’s experience in the
industry, as well as the Company’s perceptions of historical
trends, current conditions, expected future developments and other
factors the Company believes are appropriate in these
circumstances. Forward-looking statements include, but are not
limited to, those relating to the timing and nature of the results
of clinical studies and the impact of such results. Such statements
are based on current expectations that involve a number of known
and unknown risks, uncertainties and other factors that may cause
actual events to be materially different from those expressed or
implied by such forward-looking statements, including risks that
additional phases of clinical studies may not be successfully
undertaken or completed, that the FDA may not ultimately approve
the product candidate, the risk that any marketing approvals, if
granted, may have significant limitations on use, that even if an
NDA is approved, the Company may not be able to successfully
commercialize the product candidate, risks relating to the
Company’s ability to protect its intellectual property rights and
such other risks as are identified in the Company’s most recent
Annual Report on Form 10-K and in any subsequent quarterly reports
on Form 10-Q. These documents are available on request from Repros
Therapeutics or at www.sec.gov. Repros disclaims any intention or
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
For more information, please visit the Company’s
website at http://www.reprosrx.com.
CONTACT:
Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com
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