FDA Clears Path for YouthBio’s First-in-Human Alzheimer’s Trial with YB002

FDA Clears Path for YouthBio’s First-in-Human Alzheimer’s Trial with YB002

By, Admin 26 September 2025

YouthBio Therapeutics, a biotech advancing partial cellular reprogramming to treat diseases of aging, announced a successful INTERACT meeting with the U.S. FDA for its lead Alzheimer’s candidate, YB002.

The FDA agreed that existing preclinical data support YB002’s bioactivity and YouthBio’s proposed first-in-human trial. This marks a major de-risking event, enabling the company to shift focus toward CMC activities, a pilot toxicology study, and preparation for a Pre-IND meeting.

A Pivotal Inflection Point

“We are thrilled with this INTERACT outcome. The FDA’s response confirms our capital-efficient development strategy for YB002 and positions YouthBio to be the first to bring partial reprogramming to the human brain.”

  • Yuri Deigin, CEO of YouthBio.

Strong Scientific Foundation

YouthBio’s progress builds on a growing body of evidence:

  • A joint study with Dr. Alejandro Ocampo showed YB002 ameliorated cognitive decline in aged mice.
  • Additional Alzheimer’s models demonstrated reversal of disease pathology, reduction of epigenetic aging, and restoration of memory and learning.

“The FDA’s recognition of our proof-of-concept data is highly encouraging, This allows us to focus resources on building the most robust IND package possible.”

  • Dr. João Pedro de Magalhães, CSO.

About YB002

  • First-in-class gene therapy designed to transiently express Yamanaka factors in the brain.
  • Built on Nobel Prize–winning science in partial cellular reprogramming.
  • Goal: reverse age-associated epigenetic changes, restore youthful gene expression, and improve cellular function while preserving cell identity.

“It is gratifying to see partial reprogramming move toward clinical translation. This milestone is critical for both YouthBio and the broader aging research community.”

  • Dr. Alejandro Ocampo, whose 2016 paper launched the field.

About YouthBio Therapeutics

YouthBio Therapeutics is developing a new class of medicines targeting age-related diseases through partial cellular reprogramming. Its lead program, YB002, is being advanced for the treatment of Alzheimer’s disease.

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