TransTech readies Alzheimer's disease treatment for late-stage clinical trials
High Point, N.C. —
The High Point company said that it has completed a meeting with the Food and Drug Administration reviewing the phase II clinical trial results of the compound TTP488, which is being developed for the treatment of mild to moderate Alzheimer’s disease. In an 18 month mid-stage trial, TTP488 slowed cognitive decline in patients with the disease.
TransTech said the FDA agreed that the phase II data is sufficient to support starting the next phase of clinical trials. The company said in coming weeks it would also request a “special protocol assessment,” or SPA, from the FDA. An SPA is an agreement with the agency on the clinical trial design, endpoints and analysis of the trial. The agreement is an understanding of what TransTech needs to do in the trial in order to secure TTP488’s approval.
"We are very pleased with the outcome of the end of Phase II meeting and look forward to working with the FDA to finalize the phase III study design via the FDA's Special Protocol Assessment program," TransTech CEO Adnan Mjalli said in a statement. "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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