BOSTON, Aug. 17, 2016 /PRNewswire/ -- Juniper
Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a
women's health therapeutics company, today announced that a
recently completed Phase 2b clinical trial evaluating its 10%
lidocaine bioadhesive vaginal gel, COL-1077, for the reduction of
pain intensity in women undergoing an endometrial biopsy with
tenaculum placement did not achieve its primary and secondary
endpoints. The safety and pharmacokinetic (PK) profiles of
COL-1077 were consistent with what has been observed in prior
clinical trials of the lidocaine bioadhesive vaginal gel.
"We are disappointed that COL-1077 did not achieve the desired
effect in this clinical trial. We believe the study was
well-designed and -conducted, and has adequately tested our
hypothesis," said Dr. Bridget A.
Martell, Juniper's Chief Medical Officer. "On behalf
of the Juniper team, I want to thank the patients and investigators
who participated in this study."
"Based on the results of this trial, we are discontinuing
development of COL-1077," said Alicia
Secor, Chief Executive Officer. "We will focus
Juniper's resources on our differentiated intravaginal ring (IVR)
technology to advance our pipeline of product candidates to address
unmet needs in women's health."
Juniper's IVR programs are led by JNP-0101, an investigational
oxybutynin IVR for the treatment of overactive bladder (OAB) in
women. Roughly nine million women receive pharmacotherapy for
this chronic condition in the United
States alone. IND-enabling animal PK studies are underway,
and the Company expects pilot study results later this year.
"We expect to fund our operations and planned R&D activities
with cash flows generated by our core business. We expect
ongoing strong performance from the Crinone® franchise
and Juniper Pharma Services," Ms. Secor added.
"We remain committed to delivering value-added treatments that
meet the unique and underserved healthcare needs of women," Ms.
Secor concluded.
COL-1077-07 Study Design
This Phase 2b randomized, double-blinded, placebo-controlled,
multi-center clinical trial was designed to evaluate the safety and
efficacy of COL-1077 10% lidocaine bioadhesive vaginal gel compared
to a placebo bioadhesive gel for the reduction of pain intensity in
women undergoing pipelle-directed endometrial biopsy with tenaculum
placement. The primary efficacy endpoint was reduction in
pain intensity at the time of endometrial biopsy on a validated
0-10 Numerical Pain Rating Score (NPRS), with secondary endpoints
assessing the reduction in post-procedural pain and cramping over a
24-hour time period.
The trial enrolled 187 women (39 to 74 years old) at 25 sites
across the United States. Patients were randomized on a 2:1
ratio to receive either COL-1077 10% lidocaine bioadhesive vaginal
gel or placebo bioadhesive gel. Patients self-administered
the gel approximately six hours prior to the scheduled outpatient
appointment.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. is focused on developing
therapeutics that address unmet medical needs in women's
health. The Company is advancing a pipeline of proprietary
product candidates that leverage novel intravaginal drug delivery
technologies and the 505(b)(2) regulatory pathway. Juniper's
core operating business includes the
Crinone® (progesterone gel) franchise and Juniper
Pharma Services, which provides high-end fee-for-service
pharmaceutical development and clinical trials manufacturing to
clients. Please visit www.juniperpharma.com for more
information.
Juniper Pharmaceuticals™ is a trademark of Juniper
Pharmaceuticals, Inc., in the U.S. and EU.
Crinone® is a registered trademark of Merck KGaA,
Darmstadt, Germany, outside the
U.S. and of Allergan, Inc. in the U.S.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements
relating to the strength of Juniper's core business and
expected cash flows from this business; anticipated expenditures in
future periods; the development of new product candidates; and the
potential of Juniper's proprietary drug delivery platforms and
product candidates; the expected timing
of results of the JNP-0101 pilot study; and,
Juniper's ability to leverage the 505(b)(2) pathway
for product candidates.
Management believes that these forward-looking
statements are reasonable as and when made. However, such
forward-looking statements involve known and unknown risks,
uncertainties, and other factors that may cause actual results to
differ materially from those projected in the forward-looking
statements. These risks and uncertainties include, but are
not limited to: risks associated with the drug
development process generally, including the outcomes of planned
clinical trials and the regulatory review process; the risk that
the results of previously conducted studies involving our product
candidates will not be repeated or observed in ongoing or future
studies or following commercial launch, if such product candidates
are approved; risks associated with obtaining, maintaining and
protecting intellectual property; risks associated with Juniper
Pharmaceuticals' ability to enforce its patents against infringers
and defend its patent portfolio against challenges from third
parties; the risk of competition from currently approved therapies
and from other companies developing products for similar uses; risk
associated with Juniper Pharmaceuticals' ability to manage
operating expenses and/or obtain additional funding to support its
business activities; and risks associated with Juniper
Pharmaceuticals' dependence on third parties. For a
discussion of certain risks and uncertainties associated
with Juniper Pharmaceuticals' forward-looking
statements, please review the Company's reports filed
with the SEC, including, but not limited to, its Annual Report on
Form 10-K for the period ended December 31, 2015 and
Quarterly Report on Form 10-Q for the period
ended June 30, 2016.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date on
which they are made. These statements are based on management's
current expectations and Juniper
Pharmaceuticals does not undertake any responsibility
to revise or update any forward-looking statements contained
herein, except as expressly required by law.
Contact
Amy Raskopf
Director, Corporate Communications, Juniper Pharmaceuticals,
Inc.
(917) 673-5775 / ir@juniperpharma.com
Media:
Amy Covino
Tell Med Strategies
(201) 774-3111 / amy.covino@tmstrat.com
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SOURCE Juniper Pharmaceuticals, Inc.