The Food and Drug Administration (FDA) has granted Fast Track designation to UB-311 for the treatment of Alzheimer disease.

UB-311 is an immunotherapeutic vaccine candidate that targets toxic forms of aggregated amyloid beta in the brain, which contributes to the progression of Alzheimer disease.  

In clinical trials, UB-311 was found to be well tolerated in patients with mild to moderate Alzheimer disease over 3 years of repeat dosing. The product’s safety profile was observed to be comparable to placebo; no cases of amyloid-related imaging abnormalities-edema were reported in the main study (ClinicalTrials.gov Identifier: NCT02551809). A robust and durable anti-amyloid beta antibody response was also elicited in patients.

“We are excited that the FDA has granted UB-311 Fast Track designation, as it recognizes the evidence demonstrating the potential for UB-311 to address a serious unmet medical need for patients with Alzheimer disease,” said Mei Mei Hu, CEO of Vaxxinity. “We are on an encouraging clinical path for UB-311 and look forward to collaborating with the FDA and other global regulatory agencies to bring UB-311 expeditiously to the global market.”

The Company expects to initiate a phase 2b study in late 2022.

Reference

Vaxxinity receives FDA Fast Track designation for UB-311 for treatment of Alzheimer disease. News release. Vaxxinity, Inc. Accessed May 2, 2022. https://www.globenewswire.com/news-release/2022/05/02/2433453/0/en/Vaxxinity-Receives-FDA-Fast-Track-Designation-for-UB-311-for-Treatment-of-Alzheimer-s-Disease.html