TransTech Pharma, Inc. Completes End of Phase 2 Meeting With FDA for TTP488

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HIGH POINT, N.C.--(BUSINESS WIRE)--TransTech Pharma 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").

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