Inspire Terminates Phase 2 Clinical Trial for Platelet Aggregation Inhibitor.DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ISPH ISPH Inspire Pharmaceuticals, Inc. ) announced today that it has terminated its Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. of INS INS abbr. 1. Immigration and Naturalization Service 2. International News Service Noun 1. INS 50589 Antiplatelet an·ti·plate·let adj. Acting against or destroying blood platelets. antiplatelet directed against or destructive to blood platelets; inhibiting platelet function. , based on the unanimous recommendation of its independent Data Monitoring Committee (DMC DMC Devil May Cry (video game) DMC Detroit Medical Center DMC Darryl McDaniels (rapper) DMC Destination Management Company DMC Del Mar College (Corpus Christi, TX) ), following a planned interim safety analysis. INS50589 is a selective and reversible inhibitor of the platelet P2Y12 adenosine diphosphate receptor. The Phase 2 proof-of-concept clinical trial was a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind comparison of three doses of INS50589 (0.2, 0.5, and 1 mg/kg/hour) to placebo by intravenous infusion and was targeted to enroll approximately 160 subjects undergoing coronary artery bypass graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ) surgery. After the planned interim review of data from 27 patients enrolled and treated in the trial, the DMC recommended that Inspire terminate the trial at all dose levels. Although there were no deaths reported in the trial, the DMC observed a range of bleeding complications. "We have accepted the DMC's recommendation, which was based on careful and thorough evaluation of the available data," said Donald J. Kellerman, Pharm.D., Inspire's Senior Vice President, Development. "We have notified the U.S. Food and Drug Administration and are communicating with investigators about this action. Once we gain access to the data, we plan to conduct a thorough internal analysis to better understand the findings of the DMC. However, based on our current information, it is likely that we will reallocate time and capital to key programs in our core therapeutic areas of Ophthalmology and Respiratory/Allergy." About Inspire Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. The research and development programs of Inspire are driven by extensive scientific experience in the therapeutic areas of ophthalmology and respiratory/allergy, and supported by expertise in the field of P2 receptors. Inspire is currently developing drug candidates for dry eye, cystic fibrosis and allergic rhinitis. Inspire's U.S. specialty sales force promotes Elestat(R) (epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis(R) (cyclosporine ophthalmic emulsion cyclosporine ophthalmic emulsion Sandimmun (UK), Restasis Pharmacologic class: Polypeptide antibiotic Therapeutic class: Immunosuppressant Pregnancy risk category C FDA Boxed Warning) 0.05% for dry eye, ophthalmology products developed by Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. 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. 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 seasonality of Elestat, intellectual property rights, adverse litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. developments, adverse developments in the U.S. Securities and Exchange Commission (SEC) investigation, 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. Inspire's intended internal analysis of the data may not result in any information that aids Inspire in progressing its INS50589 Antiplatelet program. Inspire can make no assurance if or when it will reallocate time and capital to other therapeutic areas or, if it does so, the amount of capital or the therapeutic areas that may be impacted by such a reallocation. 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. |
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