FDA Grants Fast Track to FELIQS' FLQ-101 for Retinopathy of Prematurity Prevention

FUKUOKA, Japan & NEW YORK--FELIQS®, a clinical stage multinational biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead asset, FLQ-101, for the prevention of retinopathy of prematurity (ROP). The company is set to commence a Phase 1b/2 study of FLQ-101, termed the tROPhy-1 study, in the first quarter of 2025 across the US and Japan. The FDA’s Fast Track designation aims to accelerate the development and review of medications that show potential for treating serious conditions and addressing unmet medical needs.

FLQ-101 is a once-daily oral/intravenous solution designed to enhance the physiological response of vascularization in the retina and protect against inflammation and abnormal neovascularization. In 2024, the FDA also granted FLQ-101 Orphan Drug designation. FELIQS plans to submit an Investigational New Drug (IND) application for its second asset, FLQ-104, aimed at treating intermediate dry age-related macular degeneration (AMD) in the second half of 2025.

Ken-ichiro (Nobu) Kuninobu, Ph.D., RPh, Co-founder and Chief Executive Officer of FELIQS, stated, "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 added, “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."

Retinopathy of prematurity (ROP) is a developmental disorder marked by abnormal retinal blood vessel growth in extremely premature infants. In 2019, approximately 27,000 premature neonates in the United States were affected by ROP, making it one of the leading causes of childhood blindness. Current FDA-approved ROP treatments, such as laser photocoagulation and anti-VEGF therapy, are applied post-ROP development, require anesthesia, carry a risk of retinal detachment, and may increase intraocular infection risk. The success of these treatments depends on early disease detection and management and may come with long-term complications.

FELIQS Corporation is a clinical stage multinational biopharmaceutical firm headquartered in Fukuoka, Japan, with a US office located in JLABS@NYC. The company focuses on developing first-in-class small molecules targeting lipid oxidation.

It is important to note that FLQ-101 is an investigational medicine and has not yet received regulatory approval for the prevention of ROP.