Healthcare Industry News: denufosol
News Release - November 4, 2009
Inspire Completes Patient Enrollment in Three Late-Stage Clinical Trials in Cystic Fibrosis, Dry Eye and BlepharitisDURHAM, N.C.--(HSMN NewsFeed)--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(TM) and AZASITE(R), 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(TM) 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(R) 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).
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.
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 for AZASITE for the treatment of blepharitis.
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(TM) (diquafosol tetrasodium ophthalmic solution) 2% for dry eye and denufosol tetrasodium for cystic fibrosis, which are both in Phase 3 development and AZASITE(R) (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(R) (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based on net sales of RESTASIS(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye. For more information, visit www.inspirepharm.com.
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.
Source: Inspire Pharmaceuticals
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