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."
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).
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.
Inspire Pharmaceuticals, Inc.
Jenny Kobin, 919-941-9777, Extension 219
VP, Investor Relations and Corporate Communications
Cara Amoroso, 919-941-9777, Extension 266
Manager, Corporate Communications