Eye drop innovation is taking a significant step forward with NexThera Co., Ltd. filing a Phase 1/2a Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for NT-101, a non-invasive eye drop designed for the treatment of wet age-related macular degeneration (AMD).
NexThera’s NT-101 is a pioneering drug candidate developed using a proprietary eye drop delivery platform. This innovative technology allows for the safe and convenient delivery of therapeutic substances into retinal tissue, potentially eliminating the need for invasive intraocular injections. This is especially crucial as wet AMD is a leading cause of blindness among older adults.
Eye Drop Innovation: Addressing the Risks and Complications of Current VEGF Injections
Current treatments often rely on antibody therapies targeting vascular endothelial growth factor (VEGF), necessitating uncomfortable and risky intraocular injections. These injections can lead to complications such as infection, bleeding, retinal detachment, retinal atrophy, and fibrosis with long-term use. Therefore, there is a significant demand for a safe and convenient eye drop treatment to address this unmet medical need.
NT-101 contains an endogenous peptide as the active substance and a carrier protein, showing comparable or superior efficacy to existing antibody-based treatments. The carrier protein enhances retention on the ocular surface and improves drug delivery to retinal tissue, surpassing the efficacy of the active ingredient alone. Unlike conventional treatments that mainly target VEGF inhibition and carry various side effects, NT-101 offers a dual advantage by both suppressing angiogenesis and protecting optic nerve cells through a balanced regulation of angiogenic and anti-angiogenic factors.
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 involve administering 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. This trial aims to establish NT-101 as a breakthrough treatment for wet AMD and potentially pave the way for its application to other retinal neovascular diseases, such as diabetic retinopathy.
NexThera, founded in February 2020, is a biopharmaceutical research and development company that utilizes platform technology. Through strategic partnerships and investments, NexThera has established itself as a key player in the field. The company has entered into joint development agreements with EyeGene Inc. and BMI Korea Co., Ltd., and has secured a total of KRW 16.3 billion (approximately USD 11.8 million) in financing through various channels, including seed financing, Series A investment, and bridge investment.
Eye Drop Clinical Trial: NT-101 Toxicity Assessment by CorestemChemon Inc
For the NT-101 clinical trial, CorestemChemon Inc. performed the toxicity assessment, with nonclinical guidance provided by QuBEST BIO Co., Ltd. KCRN Research, Inc. in the United States served as the contract clinical research organization (CRO), and BMI Korea Co., Ltd. manufactured the clinical trial drug product (DP).
NexThera was co-founded by two medical professors in Busan, South Korea. The company is led by CEO SaeGwang Park, a physician-scientist (MD, PhD) and professor at Inje University School of Medicine. Dr. Park has a rich academic background, including a major in basic medicine from Inje University School of Medicine, master’s and doctoral degrees from Seoul National University Graduate School of Medicine, and research experience at the University of Chicago.
Jee-Yeong Jeong (PhD), Co-Founder and CTO of NexThera, has an impressive background in biotechnology. After earning his BS and MS degrees in biochemistry from Yonsei University, he began his career at LG Chem Biotechnology Research Institute. He later earned his PhD from Purdue University, USA, taught at Harvard Medical School, and is currently a professor at Kosin University College of Medicine.
NexThera is dedicated to developing advanced therapeutics and platforms leveraging the unique strengths and extensive biomedical research experience of its co-founders. In addition to NT-101, NexThera is advancing a biobetter development platform and technology for inhibiting selective protein synthesis in cancer cells.
The biobetter development platform utilizes self-assembling proteins, applicable to various protein drugs and biobetters, including peptides, enzymes, and antibody fragments. This platform is currently being optimized following patent applications and candidate selection. The technology for selective inhibition of protein synthesis in cancer cells has been selected by the Korea Drug Development Fund (KDDF) 2023 for government research grants, focusing on the identification of lead compounds.
To optimize its research and development activities, NexThera has established a dedicated research center with a team of highly qualified researchers, recently strengthened by clinical development experts and biopharmaceutical manufacturing specialists with extensive IND experience. This strategic expansion aims to accelerate NexThera’s development and commercialization efforts, ensuring the company remains at the forefront of innovation in treating retinal and other diseases.
Resource: Business Wire, July 17, 2024
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
