The Meals and Drug Administration (FDA) has granted Quick Observe designation to UB-311 for the therapy of Alzheimer illness.
UB-311 is an immunotherapeutic vaccine candidate that targets poisonous types of aggregated amyloid beta within the mind, which contributes to the development of Alzheimer illness.
In scientific trials, UB-311 was discovered to be nicely tolerated in sufferers with delicate to average Alzheimer illness over 3 years of repeat dosing. The product’s security profile was noticed to be similar to placebo; no instances of amyloid-related imaging abnormalities-edema have been reported in the principle research (ClinicalTrials.gov Identifier: NCT02551809). A sturdy and sturdy anti-amyloid beta antibody response was additionally elicited in sufferers.
“We’re excited that the FDA has granted UB-311 Quick Observe designation, because it acknowledges the proof demonstrating the potential for UB-311 to deal with a critical unmet medical want for sufferers with Alzheimer illness,” mentioned Mei Mei Hu, CEO of Vaxxinity. “We’re on an encouraging scientific path for UB-311 and stay up for collaborating with the FDA and different international regulatory businesses to deliver UB-311 expeditiously to the worldwide market.”
The Firm expects to provoke a section 2b research in late 2022.
Reference
Vaxxinity receives FDA Quick Observe designation for UB-311 for therapy of Alzheimer illness. Information launch. Vaxxinity, Inc. Accessed Might 2, 2022. https://www.globenewswire.com/news-release/2022/05/02/2433453/0/en/Vaxxinity-Receives-FDA-Quick-Observe-Designation-for-UB-311-for-Therapy-of-Alzheimer-s-Illness.html
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