Repros Reports Topline Positive Clinical Data After Two 18 Week Courses of Proellex® Delivered Orally and Vaginally for the ...
November 14 2016 - 4:01PM
Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported the topline
results for both its pooled oral and vaginal delivery Phase 2
studies in the treatment of uterine fibroids. Both studies enrolled
women with confirmed fibroids by MRI at baseline and who were
experiencing more than 80 mL of blood loss during menses as
confirmed by alkaline hematin assessment. Proellex® at doses of
both 6 and 12 mg, delivered by either route, substantially and
significantly reduced excessive menstrual bleeding, the key symptom
of uterine fibroids and the primary endpoint of the studies. The
study of vaginal delivery enrolled 42 subjects and the oral
delivery study’s intent-to-treat population included 41 subjects.
Amenorrhea, cessation of menses, is known to occur when a
sufficiently high plasma concentration of Proellex® is
achieved. Subjects received 18 weeks of blinded treatment and
were then withdrawn from the study medication to allow for
menses. After menses occurred, a second 18 week course of
treatment ensued. The study treatment assignments remained
blinded to the subjects, physicians and those managing the study
and data.
The incidence of amenorrhea in active treatment groups
consistently showed a statistically significantly difference from
the rate in placebo-treated subjects with both routes of
administration. At the end of the second course of treatment (36
weeks total active treatment, or Last Observation Carried Forward,
LOCF), 92.9% of oral Proellex®-treated subjects achieved
amenorrhea, while only 50% of vaginally treated subjects stopped
menses. The oral dosage form provided for consistent suppression of
menses with evidence of a dose response. Furthermore, among those
women who completed the second 18 week course of oral drug
administration, 100% of the women at the 12 mg dose exhibited
amenorrhea, whereas 88.9% of women on the 6 mg dose achieved
amenorrhea.
Along with changes in menstrual patterns, fibroid size, measured
by MRI, was reduced in volume. Fibroid volume decreased in the oral
Proellex®-treated arms by a median of 42.0% (LOCF) and was
statistically different from the change from baseline volume in the
placebo subjects (0%, p = 0.0004). For women who
completed the two 18 week courses of treatment, fibroid size
reduction for the 12 mg oral and 6 mg oral doses was 58.2% and
32.9%, respectively, providing some evidence of a dose response
effect.
The Uterine Fibroid Symptom Quality of Life Survey (UFSQOL) was
utilized in this study. The UFSQOL assesses distress from
both bleeding and the bulk symptoms of uterine fibroids. Bulk
symptoms include distress associated with pelvic pressure, frequent
urination and fatigue. Proellex®-treated subjects experienced a
LOCF median 70.9% improvement while placebo-treated subjects
reported a 37.5% improvement (p = 0.0211).
The drug was generally well tolerated.
Joseph Podolski, President and CEO of Repros, commented, “We
believe the benefit:risk profile of Proellex® could afford a
significant advantage over GnRH agonists and antagonists in the
treatment of uterine fibroids. The longer treatment period and
apparent improvement in efficacy based on the incidence of
amenorrhea compared to other selective progesterone antagonists is
also encouraging.”
The Company plans to request, before the end of this year, a
meeting with the FDA to discuss Phase 3 development of the oral
dosage form.
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 ongoing and future clinical studies
and the timing and results thereof, the Company’s plans to
communicate with the FDA, possible submission of one or more NDAs
and the commercial potential of Proellex®, 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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