Alzheimer's treatment success moves it onto Phase 3 clinical testing

Positive results in Phase II testing of the Alzheimer's drug treatment, TTP488, has led to preparations for Phase III testing to begin. The company that has developed the drug, TransTech, has announced that the End of Phase II meeting with the US Food and Drug Administration (FDA) was a success, meaning that registration for the next phase of clinical trials will soon take place.

According to the FDA, Phase II testing of TTP488 was significant to warrant and to support further testing of the drug. The tests are being performed on patients that are suffering with mild to moderate Alzheimer's disease and previous testing has shown that over an 18-month period patients experienced a slower rate of cognitive impairment.

The clinical trial process of TTP488 has been granted special fast track status by the FDA, meaning that trials can be performed at a faster rate than is standard protocol. The review of the drug after all stages of clinical testing are complete will also be much quicker than is usual. The overall approval of the drug will be a much faster process overall, allowing it to be released onto the market quicker than if it had to follow the usual protocols.

Adnan Mjalli, chief executive of TransTech, said: "We are very pleased with the outcome of the end of Phase II meeting and look forward to working with the FDA to finalise the Phase III study design via the FDA's Special Protocol Assessment programme. 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."

TTP488 works by blocking the receptor for advanced glycation endproducts (RAGE). It also works to halt the ability of any molecules or other chemicals to bind with RAGE. Previous research into Alzheimer's disease has suggested that amyloid protein, which builds up as plaques on the brain and could be a leading cause of damage to brain neurons and cause cognitive decline, interacts with RAGE. This could reduce the amount of plaque that builds up on the brain and improve overall cognitive health in patients.