FDA grants fast track status to FELIQS’ FLQ-101 for ROP

(Image Credit: AdobeStock/Olena Bloshchynska)

The US Food and Drug Administration (FDA) has granted the lead asset for FELIQS, FLQ-101, Fast Track designation for the prevention of retinopathy of prematurity (ROP). According to a press release¹ from the company, FELIQS plans to conduct a Phase 1b/2 study of FLQ-101 (tROPhy-1 study) both in the US and Japan in the first quarter of 2025.

The candidate, FLQ-101, is a once-daily oral/intravenous solution that enhances the physiologic response of vascularization in retina and protects from inflammation and abnormal neovascularization.¹

Ken-ichiro (Nobu) Kuninobu, PhD, RPh, co-founder and chief executive officer at FELIQS is quoted in the news release1 about this development, saying, "With no approved preventative treatments available for retinopathy of prematurity, receiving the Fast Track designation for FLQ-101 is an important milestone for our company. This designation will facilitate the review process and give us better access to FDA which should shorten the clinical development program timeline and improve the chances of designing and conducting a successful program." He continues, “We are excited that FDA recognized the unmet medical need in the target population and that FLQ-101 could potentially close this gap. At FELIQS, we are committed to help the most vulnerable members of society. This is exemplified by our focus on extremely premature neonates with the FLQ-101 program and the elderly patients with intermediate dry-AMD with the FLQ-104 program."

The FDA grants investigational medicines Fast Track designation to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need. In 2024, the FDA granted FLQ-101 Orphan Drug designation. Additionally, the company is on track to submit an IND for its second asset, FLQ-104, for intermediate dry-AMD in 2H2025.¹

Reference:

1. FELIQS Receives U.S. FDA Fast Track Designation for FLQ-101, a First-in-class Small Molecule to Prevent Retinopathy of Prematurity. FELIQS. Published November 1, 2024. Accessed November 5, 2024. https://www.businesswire.com/news/home/20241101999475/en/FELIQS-Receives-U.S.-FDA-Fast-Track-Designation-for-FLQ-101-a-First-in-class-Small-Molecule-to-Prevent-Retinopathy-of-Prematurity