FDA grants breakthrough designation to frontotemporal dementia treatment

Key takeaways:

• Latozinemab is an investigational human monoclonal antibody.
• The drug is currently being examined in a phase 3 clinical trial.

The FDA has granted breakthrough therapy designation to latozinemab, an investigational therapeutic designed to block sortilin and elevate progranulin to treat frontotemporal dementia with a progranulin gene mutation.

According to a press release from Alector Inc., the breakthrough designation was approved based on data from the phase 2 INFRONT-2 clinical trial of latozinemab in patients with the condition.

Breakthrough designation is granted by the FDA to expedite development and review of drugs developed to treat a serious condition, when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over currently available therapies.

In July 2021, Alector entered into a license agreement with GSK on global development and commercialization of progranulin-elevating monoclonal antibodies including latozinemab. Terms of the agreement stipulate the companies will equally share profits and absorb losses from commercialization in the United States, while Alector will be eligible for double-digit tiered royalties outside the U.S.

“In partnership with GSK, we are encouraged and excited by this FDA breakthrough designation,” Alector CEO Arnon Rosenthal, PhD, said in the release. “[Frontotemporal dementia with progranulin gene mutation] is a rare and rapidly progressing neurodegenerative disease and one of the most common causes of early onset dementia.”

Alector further stated in the release that latozinemab is currently under investigation in the phase 3 INFRONT-3 study, which achieved target enrollment in October 2023.