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Anavex prepares for regulatory filings based on FDA guidance

Anavex, a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, is moving forward with the development program for ANAVEX 2-73.

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The company that has recently began trading on NASDAQ, announced in September that patient enrollment for the Phase 2a clinical trial of ANAVEX 2-73 had been completed ahead of schedule.

As Anavex said, guidance received from the FDA confirms its strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial.

“Working with a highly vulnerable patient population, the Company is proceeding in a rational, step-wise process. Armed with the necessary data from the Phase 2a study to optimally design future trials, we look forward to expanding our development program,” said Kristina M. Capiak, Vice President Regulatory Affairs of Anavex.

Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, said:  “The utilization of Adaptive Design and Population Pharmacokinetics/ Pharmacodynamics (PK/PD) modeling is a major strength of the Phase 2a study.”

“By implementing a different, innovative trial design for ANAVEX 2-73 in Alzheimer’s treatment, it is believed that this is more efficient than a conventional Phase 2 study since it is designed to reduce the risk of a Phase 3 trial failure, as well as receiving the best quality information we can about ANAVEX 2-73.”

Missling explained that the advantage of having Population PK/PD data is of value for the development of ANAVEX 2-73 in Alzheimer’s disease and also for other potential CNS indications.”

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