Earlier this month, FELIQS announced that the FDA granted Fast Track designation to its lead asset (FLQ-101, a small molecule) for the prevention of retinopathy of prematurity (ROP).
First up: this company.
Launched in 2019 and headquartered in Fukuoka, Japan—with a U.S. location in New York City, New York—FELIQS is a clinical-stage multinational biopharmaceutical company funded with a seed round of $2.5 million.
- Its clinical portfolio: Two patient-protected, first-in-class small molecules targeting lipid oxidation (see below)—both with capabilities to be administered orally and intravenously
And those diseases/candidates are …
- Dry age-related macular degeneration (AMD)
- Candidate: FLQ-104
- ROP
- Candidate: FLQ-101 (or topic of choice)
Back in June 2024: The company reported plans to initiate a Series A round of funding targeting $20 million to initiate a clinical trial for FLQ-101 and preclinical research on FLQ-104.
How were these two candidates identified?
Per FELIQS, identification was conducted via its proprietary drug screening platform—which targets “lipid peroxidation/ferroptosis”—as well as “proven efficacy” from prior prospective human clinical trials.
- To note: No clinical data on either candidate is readily available.
Also, keep in mind: Both lipid peroxidation—a result of oxidative stress—and ferroptosis, a type of cell death involving lipid peroxidation, are involved in ROP development.
Now a refresh on Fast Track designation.
What it is: A company request to the FDA to facilitate the development and expedite the review of a drug to treat serious medical conditions and fill an unmet need.
- In other words: It’s a way to make new drugs available to patients faster.
And unlike a Breakthrough Therapy designation, this designation can be requested with non-clinical data and/or preliminary clinical evidence.
Next: the candidate.
As the lead asset in the company’s clinical portfolio, FLQ-101 is a lipid modulator designed as a once-daily oral/intravenous solution intended to enhance “the physiologic response of vascularization” within the retina as well as protect from:
- Inflammation
- Abnormal neovascularization
This isn’t its first designation, right?
Indeed. The FDA already granted FLQ-101 Orphan Drug designation earlier this year, according to the company.
Nice! Now I have to ask: Why ROP?
While the FDA has already approved the first pharmacological treatment for ROP in infants—Regeneron’s Eylea (aflibercept)—there has yet to be preventative treatment available for this patient base.
As such, FELIQS Co-Founder and CEO Ken-ichiro (Nobu) Kuninobu, PhD, RPh, stated that this designation will not only facilitate the review process of FLQ-101, but also provide the company with better access to the FDA, “which could shorten the clinical development program timeline and improve the chances of designing and conducting a successful program.”
And what’s the plan moving forward?
FELIQS is planning to initiate a phase 1b/2 study on FLQ-101 (dubbed “tROPhy-1”) across both the United States and Japan in Q1 2025.
And outside this proposed ROP indication, the company also reported that it is currently on track to “submit an IND (investigational new drug) for its second asset, FLQ-104, for intermediate dry AMD” in H2 2025.
So you know what that means … stay tuned!