FDA agrees preclinical data support YB002 bioactivity and a future first-in-human trial in Alzheimer's patients
SEATTLE, Sept. 25, 2025 /PRNewswire/ -- YouthBio Therapeutics, a biotechnology company pioneering partial cellular reprogramming to treat diseases of aging, today announced a successful INTERACT meeting with the FDA for its lead Alzheimer's candidate, YB002. In its formal response, the FDA agreed that existing preclinical data support the bioactivity of YB002 and YouthBio's proposed first-in-human trial. This feedback represents a major de-risking event for YouthBio, which will now focus on CMC activities and a pilot toxicology study to support a Pre-IND meeting and finalize designs for IND-enabling studies.
"We are thrilled with this INTERACT outcome," said Yuri Deigin, CEO of YouthBio. "The FDA's response confirms our capital-efficient development strategy for YB002 and provides a clear path to the clinic. This is a significant inflection point, shifting the conversation from scientific plausibility to execution, and positioning YouthBio to be the first to bring partial reprogramming to the human brain."
This milestone continues YouthBio's strong record of execution. It builds upon compelling scientific evidence, including a study with Dr. Alejandro Ocampo where YB002 ameliorated cognitive decline in mice. Additional Alzheimer's models have demonstrated that partial reprogramming can reverse disease pathologies, counteract epigenetic aging, and rescue memory and learning.
"The FDA's recognition of our proof-of-concept data is highly encouraging from a scientific perspective," said Dr. João Pedro de Magalhães, CSO of YouthBio. "Their detailed feedback allows us to focus our resources effectively and build the most robust IND package possible."
YB002 is a first-in-class gene therapy designed to safely and transiently express Yamanaka factors in the brain — a process known as partial reprogramming. Built on Nobel Prize-winning science, this approach aims to reverse epigenetic changes that accumulate with aging while preserving cell identity, thereby restoring youthful gene expression and improving cellular function.
"It is gratifying to see the field of partial reprogramming entering clinical translation," said Dr. Alejandro Ocampo, whose pioneering 2016 paper launched the field of partial reprogramming. "In our joint study with YouthBio, YB002 ameliorated cognitive decline in old wild-type mice. This FDA feedback marks a critical milestone for both YouthBio and the entire field."
Media contact: yuri@youthbiotx.com
About YouthBio Therapeutics, Inc.
YouthBio Therapeutics (www.youthbiotx.com) is developing a new class of medicines to combat age-related diseases by leveraging partial cellular reprogramming. The company's lead program, YB002, is being advanced for the treatment of Alzheimer's disease.
View original content:SOURCE YouthBio Therapeutics Inc.
