NexThera Files IND Application for Phase 1/2a Clinical Trial of NT-101 Eye Drop for Wet AMD

NexThera Co., Ltd. (CEO SaeGwang Park) announced that it has submitted a Phase 1/2a Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NT-101, a non-invasive eye drop treatment for wet age-related macular degeneration (wet AMD).

NT-101 is NexThera's first new drug candidate developed using its proprietary eye drop delivery platform. This innovative technology enables the safe and convenient administration of substances to the retinal tissue, eliminating the need for invasive injections into the eye.

Wet AMD is a leading cause of blindness in the elderly. Current treatments primarily rely on antibody-based therapies targeting vascular endothelial growth factor (VEGF). However, these treatments require intraocular injections, which can be uncomfortable for patients and carry risks of infection, bleeding, and retinal detachment. Long-term administration can also lead to complications such as retinal atrophy and fibrosis. Consequently, there has been a persistent demand for a safe and convenient eye drop treatment to address this unmet medical need.

NT-101 contains an endogenous peptide as an active drug substance and a carrier protein, and it has shown comparable or superior efficacy to existing antibody treatments. Notably, the carrier's action enhances ocular surface retention and improves drug delivery to the retinal tissue, surpassing the efficacy of active ingredient alone. While conventional treatments primarily target VEGF inhibition, which can lead to side effects, NT-101 offers dual benefits by not only suppressing angiogenesis but also protecting optic nerve cells through balanced regulation of angiogenic and anti-angiogenic factors.

A NexThera representative stated, “The phase 1/2a clinical trial for NT-101 is designed to evaluate the safety and tolerability of the investigational drug in patients with wet AMD. The trial will administer low or high doses of the drug to a cohort of 30 patients twice daily (morning and evening) for 28 days. Secondary objectives include monitoring changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA) following drug administration.”

SaeGwang Park, CEO of NexThera, said, “We are confident that the NT-101 clinical trial will establish it as a groundbreaking treatment for wet AMD, paving the way for further development. We're also exploring its potential application to other retinal neovascular diseases, such as diabetic retinopathy.”

NexThera, a biopharmaceutical research and development company founded in February 2020 utilizing platform technology, has established itself through partnerships and strategic investments. The company has forged joint development agreements with EyeGene Inc. and BMI Korea Co., Ltd., and secured a total of KRW 16.3 billion (about USD 11.8 million) in funding through various channels, including seed funding, Series A investment, and bridge round investment.

For the NT-101 clinical trial, CorestemChemon Inc. conducted the toxicity assessment, with non-clinical consulting provided by QuBEST BIO Co., Ltd. And, KCRN Research, Inc. in the United States served as the clinical contract research organization (CRO). The clinical trial drug product (DP) was manufactured by BMI Korea Co., Ltd.

NexThera was co-founded by two medical school professors in Busan, South Korea. Leading the company is CEO SaeGwang Park, a physician-scientist (MD, PhD) and professor at College of Medicine, Inje University. Dr. Park graduated from College of Medicine, Inje University with a specialization in basic medicine and holds master's and doctoral degrees from Seoul National University Graduate School of Medicine. He also has research experience at the University of Chicago in the United States.

Jee-Yeong Jeong (PhD), NexThera's co-founder and CTO, boasts an impressive background in biotechnology. After earning bachelor's and master's degrees in biochemistry from Yonsei University, he began his career at LG Chem's renowned Biotech Research Institute, a breeding ground for Korean biotech startups. Dr. Jeong then went on to complete his doctorate at Purdue University in the United States. He has also served as an instructor at Harvard Medical School and currently holds a professorship at Kosin University College of Medicine.

NexThera is dedicated to developing advanced treatments and platforms that leverage the unique strengths of its co-founders, drawing on their combined experience and achievements in biomedical research spanning over 20 years. In addition to NT-101, ongoing projects include advancing a biobetter development platform and cancer cell-selective protein synthesis inhibition technology. The biobetter development platform, which utilizes the properties of self-assembling proteins, is a versatile system applicable to the development of various protein drugs and biobetters, including peptides, enzymes, and antibody fragments. This platform is currently undergoing optimization following the completion of patent applications and the selection of application candidates. Additionally, the technology for selectively inhibiting protein synthesis in cancer cells has been chosen by the 2023 Korea Drug Development Fund to receive government subsidies for research due to its innovation and practicality. Research and development efforts are currently focused on successfully identifying lead compounds.

To optimize its research and development activities, NexThera has established a dedicated R&D center staffed with a team of highly qualified researchers. The company recently bolstered its team with clinical development experts and biopharmaceutical manufacturing process specialists, all boasting extensive IND experience. This strategic expansion will accelerate NexThera's development and commercialization efforts.

Learn more about NexThera and its pipeline at https://nexthera.org/en/.

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