NEWS

GenEditBio receives FDA clearance of the IND application to initiate the Phase 1/2 CLARITY trial

January 9, 2026 | AEF | Portfolio
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We are pleased to announce that our portfolio company, GenEditBio, has received FDA clearance of its Investigational New Drug (IND) application for its lead clinical asset, GEB-101. This clearance authorizes the initiation of the Phase 1/2 CLARITY trial, marking a major milestone in the company's development of novel in vivo genome-editing therapies.

**About GEB-101 and the Trial**
GEB-101 is a first-in-class investigational genome-editing therapy designed for TGFBI corneal dystrophy. It utilizes GenEditBio’s proprietary protein delivery vehicle (PDV) technology to deliver ribonucleoprotein for precise genetic correction. The clearance validates the robust preclinical safety and efficacy data supporting the program.

The Phase 1/2 CLARITY trial will evaluate the initial safety, tolerability, and efficacy of GEB-101. Patient enrollment is expected to commence in the second quarter of 2026 following clinical site activation in the United States.

This milestone reflects the focused execution and scientific rigor of the GenEditBio team in advancing its preclinical assets into clinical development. The company remains dedicated to creating safe, effective, and accessible in vivo genome-editing therapies for patients with genetic diseases lacking adequate treatment options.