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HIGH POINT, N.C.-July 2, 2013 - (BUSINESS WIRE/ME NewsWire)-- TransTechPharma Inc. announced today that it has successfully completed an End of Phase 2 meeting for TTP488 with the U.S. Food and Drug Administration (FDA). TTP488 is under development for the treatment of mild to moderate Alzheimer's disease. The FDA Division of Neurology Products agreed that the data from the completed Phase 2 clinical trial is sufficient to support the start of a Phase 3 registration program. The FDA concurred with TransTech's proposal for the overall size and design of the planned Phase 3 clinical studies, the primary endpoints, the total safety database proposed for NDA filing, the clinical pharmacology program and the plan to apply for a Special Protocol Assessment ("SPA"). The Phase 3 clinical trial design for TTP488 will focus on patients with mild to moderate Alzheimer's disease. TransTechPharma anticipates filing an SPA request within the next few weeks. “We are very pleased with the outcome of the End of Phase 2 meeting and look forward to working with the FDA to finalize the Phase 3 study design via the FDA's Special Protocol Assessment program,” said Dr. Adnan Mjalli, TransTech's Chief Executive Officer. “This development represents another significant step in advancing the development of TTP488 toward meeting the huge unmet medical need for treatment of patients with Alzheimer's disease.”
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