Inspire Completes Patient Enrollment in Three Late-Stage Clinical Trials in Cystic Fibrosis, Dry Eye and Blepharitis

* Reuters is not responsible for the content in this press release.

Wed Nov 4, 2009 7:00am EST

DURHAM, N.C.--(Business Wire)--
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today patient enrollment
is complete in three of its late-stage clinical trials. 

"We are pleased to be executing on our strategic plan with the achievement of
these patient enrollment milestones in the clinical development programs for
denufosol, PROLACRIA and AZASITE®,as this places us in a position to have
top-line results from all our late-stage clinical programs within 18 months. We
would like to thank the dedicated clinical investigators, study coordinators and
patients who participated in our trials as well as the Cystic Fibrosis
Foundation and its affiliates for raising awareness of the importance of
participating in clinical trials," stated Benjamin R. Yerxa, Ph.D., Executive
Vice President and Chief, Research and Development. 

Denufosol Tetrasodium for Cystic Fibrosis

Inspire announced today that TIGER-2, the Company`s second Phase 3 pivotal
clinical trial (Trial 08-110) with denufosol tetrasodium inhalation solution for
the treatment of cystic fibrosis (CF), has completed patient enrollment. TIGER-2
is a 48-week trial comparing 60 mg of denufosol to placebo, administered
three-times daily by jet nebulizer, in a targeted 450 CF patients. The Company
expects to have top-line results from TIGER-2 in the first quarter of 2011. 

"We are excited that patient enrollment in TIGER-2 is complete. This is an
important step toward bringing this potential new treatment to cystic fibrosis
patients," said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis
Foundation. "Denufosol`s novel approach to treating the underlying ion channel
defect in CF lung disease makes it a promising therapy, and we look forward to
the results from this trial." 

PROLACRIA for Dry Eye

Inspire also announced today that patient enrollment is complete in its Phase 3
clinical trial (Trial 03-113) with PROLACRIA, the proposed U.S. tradename for
diquafosol tetrasodium ophthalmic solution 2%, for the treatment of dry eye
disease. This is a six-week trial comparing PROLACRIA to placebo, administered
four-times daily as eye drops, in a targeted 450 dry eye patients. The trial is
based on a Special Protocol Assessment (SPA) agreement with the U.S. Food and
Drug Administration (FDA). The Company expects to have top-line results from
this trial in the first quarter of 2010. 

Gary N. Foulks, M.D., F.A.C.S., Professor of Ophthalmology and Visual Science
and Director of Corneal/External Disease at Kentucky Lions Eye Center,
University of Louisville, and principal investigator of Trial 03-113, stated,
"There is a significant need for new therapeutic treatments for dry eye disease.
With its novel mechanism of action of stimulating the production of natural tear
components, PROLACRIA could be of significant benefit to patients suffering from
dry eye." 

AZASITE® for Blepharitis

The AZASITE (azithromycin ophthalmic solution) 1% for blepharitis Phase 2
program is targeted to enroll approximately 600 patients in two trials. One
trial (Trial 044-101) includes a two-week treatment period with a two-week
follow-up period and the other trial (Trial 044-102) includes a four-week
treatment period with a four-week follow-up period. Inspire announced today that
enrollment is complete in the four-week trial and enrollment in the two-week
trial is progressing well with 250 out of a targeted 300 patients enrolled. The
Company expects to have enrollment completed in the two-week trial in the first
quarter of 2010. 

About Denufosol Tetrasodium

Denufosol tetrasodium is a first-in-class receptor-mediated chloride channel
activator that addresses the underlying ion transport defect in the lungs of
patients with cystic fibrosis (CF). Denufosol is designed to enhance airway
hydration and mucociliary clearance through receptor-mediated mechanisms that
increase chloride secretion, inhibit sodium absorption and increase ciliary beat
frequency. These integrated pharmacological actions are important to restoring
airway clearance, maintaining lung function, and potentially delaying the
progression of CF lung disease. Denufosol is targeted as an early intervention
therapy for CF lung disease. This product candidate has been granted orphan drug
and fast-track review status by the U.S. Food and Drug Administration (FDA) and
orphan drug status by the European Medicines Agency (EMEA). 

About PROLACRIA

PROLACRIA, the proposed U.S. tradename for diquafosol tetrasodium ophthalmic
solution 2%, is a proprietary and selective P2Y2 agonist Inspire is developing
for the treatment of dry eye disease.PROLACRIA is designed to stimulate the
release of the three natural tear components involved in tear secretion - mucin,
lipids and fluid. 

About AZASITE®

AZASITE(azithromycin ophthalmic solution) 1% is a prescription medicine approved
by the U.S. Food and Drug Administration for the treatment of bacterial
conjunctivitis in adults and children 1 year of age and older. AZASITE is for
topical ophthalmic use only. In clinical trials, the most frequently reported
ocular adverse event was eye irritation, which occurred in 1% - 2% of patients.
Please see full Prescribing Information for AZASITE at www.azasite.com. Inspire
is pursuing an additional potential indication forAZASITE for the treatment of
blepharitis. 

About Inspire

Inspire is a biopharmaceutical company focused on researching, developing and
commercializing prescription pharmaceutical products for ophthalmic and
pulmonary diseases. Inspire`s goal is to build and commercialize a sustainable
portfolio of innovative new products based on its technical and scientific
expertise. The most advanced compounds in Inspire`s clinical pipeline are
PROLACRIA™ (diquafosol tetrasodium ophthalmic solution) 2% for dry eye and
denufosol tetrasodium for cystic fibrosis, which are both in Phase 3 development
and AZASITE® (azithromycin ophthalmic solution) 1% for blepharitis, which is in
Phase 2 development. Inspire receives revenues related to the promotion of
AZASITE for bacterial conjunctivitis, the co-promotion of ELESTAT® (epinastine
HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based
on net sales of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% for dry eye.
For more information, visit www.inspirepharm.com. 

Forward-Looking Statements

The forward-looking statements in this news release relating to management's
expectations and beliefs are based on preliminary information and management
assumptions. These statements are based upon the current beliefs and
expectations of Inspire`s management and are subject to significant risks and
uncertainties. Specifically, there can be no assurance that Inspire will be in a
position to have top-line results from all of its late-stage clinical programs
within 18 months, top-line results from TIGER-2 in the first quarter of 2011,
and top-line results from PROLACRIA Trial 03-113 in the first quarter of 2010;
that PROLACRIA will be of significant benefit to patients suffering from dry
eye; that Inspire will be able to enroll approximately 600 patients in its two
ongoing AZASITE blepharitis trials; that enrollment will be completed in the
two-week AZASITE blepharitis trial in the first quarter of 2010; or that
denufosol will be an early intervention therapy for CF lung disease.
Additionally, there can be no assurance that Inspire will be able to build and
commercialize a sustainable portfolio of innovative new products based on its
technical and scientific expertise. Such forward-looking statements are subject
to a wide range of risks and uncertainties that could cause results to differ in
material respects, including those relating to product development, revenue,
expense and earnings expectations, intellectual property rights, competitive
products, results and timing of clinical trials, success of marketing efforts,
the need for additional research and testing, delays in manufacturing, funding,
and the timing and content of decisions made by regulatory authorities,
including the FDA. Further information regarding factors that could affect
Inspire's results is included in Inspire's filings with the SEC. Inspire
undertakes no obligation to publicly release the results of any revisions to
these forward-looking statements that may be made to reflect events or
circumstances after the date hereof.

Inspire Pharmaceuticals, Inc.
Investor Contact:
Jenny Kobin, 919-941-9777, Extension 219
VP, Investor Relations and Corporate Communications
or
Media Contact:
Cara Amoroso, 919-941-9777, Extension 266
Manager, Corporate Communications 



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.