FELIQS Receives U.S. FDA Fast Track Designation for FLQ-101, a First-in-class Small Molecule to Prevent Retinopathy of Prematurity

FUKUOKA, Japan & NEW YORK--( BUSINESS WIRE )-- FELIQS^®, a clinical stage multinational biopharmaceutical company focused on the development of first-in-class small molecules targeting lipid oxidation, announced today that the U.S. Food and Drug Administration (FDA) has granted its lead asset, FLQ-101, Fast Track designation for the prevention of retinopathy of prematurity (ROP). The company plans to conduct a Phase1b/2 study of FLQ-101 (tROPhy-1 study) both in the US and Japan in 1Q2025. 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.

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. In 2024, the U.S. Food and Drug Administration (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.

"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." said Ken-ichiro (Nobu) Kuninobu, Ph.D., RPh, Co-founder and Chief Executive Officer at FELIQS. 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."

About ROP

Retinopathy of prematurity (ROP) is a developmental vascular disorder characterized by abnormal growth of retinal blood vessels in the incompletely vascularized retina of extremely premature neonates. In the United States, ROP afflicted about 27,000 premature neonates in 2019 and remains one of the leading causes of childhood blindness. Currently available FDA approved treatments of ROP, namely laser photocoagulation and anti-VEGF therapy, are utilized after ROP development, require anesthesia, are associated with retinal detachment, and may increase the risk of intraocular infection. The efficacy of these treatments is dependent on early detection and management of the disease and may be associated with long term sequalae.

About FELIQS

FELIQS Corporation is a clinical stage multinational biopharmaceutical company. FELIQS is headquartered in Fukuoka, JAPAN and has a US office in JLABS@NYC. For more information, please visit our website at www.feliqs.com , which does not form a part of this release.

FLQ-101 is an investigational medicine that has not been approved for the prevention of ROP by regulatory authorities.

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