FDA PLACES MEMORY PHARMA'S ALZHEIMER'S DRUG STUDY ON HOLD
Memory Pharmaceuticals announced an update on the investigational new drug application (IND) filed in September for MEM 3454. The FDA has advised the company that in order to fully review the toxicology reports that were submitted with the IND, the agency requires further explanations of revisions that were made to those reports since they were submitted with the company's first IND for this trial in May, and as a result the proposed Phase IIa clinical trial for MEM 3454 in Alzheimer's disease has been placed on clinical hold. The FDA has also deferred assessment of the adequacy of the investigator's brochure for the trial pending submission of the additional information.
Memory Pharmaceuticals also reported that the FDA confirmed that the clinical hold was not related to any manufacturing issues with MEM 3454, and that the potential impurities issue, previously raised by the FDA in connection with the company's first IND, had been adequately resolved.
The company believes that no additional studies or data will be required to address the FDA's questions, and that it should be able to provide to the FDA with the information necessary to facilitate the FDA's review by early November.
MEM 3454 is a partial agonist of the nicotinic alpha-7 receptor, a highly specialized receptor found in the central nervous system. Compounds acting on this receptor could be beneficial in the treatment of Alzheimer's disease and schizophrenia, as well as other psychiatric and neurological disorders, according to the company. Memory Pharmaceuticals is developing MEM 3454 as potential therapy for Alzheimer's disease and considering developing the compound as a treatment for schizophrenia.
Upcoming Events
-
21Oct