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TIGER-1 Denufosol Phase 3 Trial for Cystic Fibrosis Published in the American Journal of Respiratory and Critical Care Medicine

^{Published on 2010-12-17 10:05:41 - Market Wire}
 

DURHAM, N.C.--([ BUSINESS WIRE ])--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.

"Denufosol Tetrasodium in Patients with Cystic Fibrosis and Normal to Mildly Impaired Lung Function"

The article entitled, aDenufosol Tetrasodium in Patients with Cystic Fibrosis and Normal to Mildly Impaired Lung Functiona (Frank J. Accurso, M.D.; Richard B. Moss, M.D.; Robert W. Wilmott, M.D.; Ran D. Anbar, M.D.; Amy E. Schaberg, BSN, RN; Todd A. Durham, M.S.; Bonnie W. Ramsey, M.D.; and the TIGER-1 Investigator Study Group), appeared today online ahead of the print edition ([ http://ajrccm.atsjournals.org/ ]).

Frank J. Accurso, M.D., Head of Pulmonary Medicine, Director of Cystic Fibrosis Center at University of Colorado, Denver, and the lead principal investigator for TIGER-1 stated, aThese exciting data suggest that denufosol may have promise in this mild patient population. The improvement in lung function observed during the placebo-controlled portion and the open-label extension of the TIGER-1 trial is notable given that the patient population studied had little to no pulmonary function impairment.a

The TIGER-1 trial included a 24-week placebo-controlled portion, followed by a 24-week open-label safety extension. The placebo-controlled portion was a double-blind, randomized trial comparing 60 mg of denufosol to placebo, administered three times daily by jet nebulizer, in 352 patients with mild CF lung disease (baseline FEV₁, or Forced Expiratory Volume in One Second, a75% of predicted normal). The TIGER-1 trial demonstrated statistical significance for its primary efficacy endpoint of change in FEV₁ from baseline compared to placebo at the Week 24 Endpoint (45 mL treatment group difference, p=0.047). In the open-label extension, patients experienced a progressive improvement in FEV₁. Detailed analyses from the trial are included in the AJRCCM publication.

Adrian Adams, President and CEO of Inspire stated, aWe believe this publication represents valuable information for the CF medical community because it puts the data from TIGER-1, the first large Phase 3 trial of an ion channel regulator, into context in the current treatment landscape. The results from our second Phase 3 trial with denufosol, TIGER-2, are expected in the first quarter of 2011, which will provide further information.a

About Denufosol Tetrasodium

Denufosol is a novel ion channel regulator that potentially corrects ion transport in patients independent of the class of CFTR defect. Denufosol is designed to enhance airway hydration and mucociliary clearance by increasing chloride secretion, inhibiting sodium absorption and increasing ciliary beat frequency. These integrated pharmacological actions and the potential to reach the small airways are key to maintaining lung function and potentially delaying the progression of lung disease.

About the Denufosol Tetrasodium Clinical Program

TIGER-1, the first Phase 3 trial with denufosol for the treatment of CF, included a 24-week placebo-controlled portion, followed by a 24-week open-label safety extension. The placebo-controlled portion was a double-blind, randomized trial comparing 60 mg of denufosol to placebo, administered three times daily by jet nebulizer, in 352 patients with mild cystic fibrosis lung disease (baseline FEV₁ a 75% of predicted normal).

Inspire expects top-line results from TIGER-2, its second Phase 3 clinical trial with denufosol, in the first quarter of 2011. Inspire is targeting a potential U.S. commercial launch for denufosol in the 2012 timeframe assuming the results of TIGER-2 are positive, that Inspire subsequently files a New Drug Application (NDA) for denufosol with the FDA in the second half of 2011 and that the FDA approves such NDA under a priority review timeline.

Inspire is conducting additional clinical trials in connection with its evolving denufosol franchise development plans and activities. Inspire is conducting DEFY (Denufosol Efficacy Over Four Years), a denufosol open-label clinical trial open to eligible patients that complete the year-long TIGER-2 trial. This three year trial will evaluate the potential disease-modifying impact of denufosol on rate of lung function decline. Inspire expects top-line results from REACH (Researching an Early Approach to Cystic Fibrosis Health), a small safety and tolerability clinical trial of denufosol in CF patients ages 2 - 4 years old, in the first quarter of 2011.

About Inspire

Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspirea™s goal is to build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial expertise. Inspire's clinical pipeline includes denufosol tetrasodium for cystic fibrosis in Phase 3 development and AZASITE^® (azithromycin ophthalmic solution) 1% for blepharitis 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. Specifically, no assurances can be made with respect to: denufosol's promise in patients with cystic fibrosis and normal to mildly impaired lung function; the timing or outcome of Inspire's second Phase 3 trial with denufosol, TIGER-2; denufosol's ability to reach the small airways of the lungs, maintain lung function or delay the progression of lung disease; the timing and outcome of TIGER-2 results in the first quarter of 2011, or otherwise; the ability to undertake, or the timing or outcome of, a U.S. commercial launch of denufosol in 2012, or otherwise; whether or not the results of TIGER-2 will be positive; the ability to file a New Drug Application (NDA) for denufosol with the FDA in the second half of 2011 or the outcome of such a filing; that the FDA will review any denufosol NDA under a priority review timeline; that the FDA will approve denufosol, even if a priority review is undertaken; the timing and outcome of the DEFY open-label clinical trial or the REACH clinical trial; and that Inspire could build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial 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, the introduction of a generic form of epinastine, 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 U.S. Food and Drug Administration. 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.