Alzheon’s Alzheimer’s Asset Enters FDA Fast Track Phase 3

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Alzheon’s Alzheimer’s asset ALZ-801 has obtained the fast track category from the Food and Drug Administration. This will allow the prodrug of tramiprosate to fly through the FDA’s evaluation process if during phase 3 the drug hits its target.

A few years ago, Alzheon had protected the drug from the being added to the pile with other failed Alzheimer’s drugs. The drug, tramiprosate, is one of numerous drugs that attempted to decrease amyloid aggregation, but failed. Alzheon saw potential behind the drug’s failure, leading to the formation of the prodrug formula and the work to utilize it for the use in a genetic subgroup of patients.

This week, a paper was published by Alzheon detailing part of that effort.

“We have built a strong body of original research and clinical analyses that support the initial evaluation of ALZ-801 in the genetically defined high-risk population of APOE4/4 homozygotes, enabling us to … move toward an upcoming pivotal study and potential approval as quickly as possible,” Alzheon CEO Martin Tolar, M.D., Ph.D., stated.

That statement made regarding the speed of ALZ-801’s development contradicts with the previous forecasts about the its development. There has been a delay with Alzheon initiating the phase 3 program, it has been over a year since the company announced having the data required to move into the new phase. Originally, it was anticipated that the phase 3 program would begin in early 2017.

The delay may be related to funding. In 2015, Alzheon assembled a $10 million series A and then sold $15.8 million worth of stock in this June. The biotech company has bragged about the capability of its medicinal approach to Alzheimer’s has reduced the number of patients and also the cost required to initiate phase 3.

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