NexThera Submits IND Application for Phase 1/2a Clinical Study of NT-101 Eye Drops Targeting Wet AMD

NexThera Co., Ltd. revealed that it has filed a Phase 1/2a Investigational New Drug application with the U.S. Food and Drug Administration for NT-101, a non-invasive eye drop therapy targeting wet age-related macular degeneration.

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NT-101 represents NexThera's inaugural drug candidate formulated via its unique eye drop delivery system. This cutting-edge platform facilitates the non-invasive and effective delivery of substances to retinal tissues, eliminating the necessity for eye injections. 

NT-101 includes an endogenous peptide as its primary active substance in conjunction with a carrier protein. It has demonstrated equal or increased effectiveness compared to current antibody therapies. Importantly, the carrier's role enhances the retention on ocular surfaces and optimizes the delivery to retinal tissues, outperforming the active ingredient in isolation.

Unlike conventional treatments, which mainly focus on VEGF inhibition and can potentially cause side effects, NT-101 provides additional advantages by not only inhibiting angiogenesis but also safeguarding optic nerve cells through a balanced modulation of angiogenic and anti-angiogenic factors. 

A NexThera spokesperson mentioned, “The phase 1/2a clinical trial aims to determine the safety and tolerability of NT-101 in patients suffering from wet AMD. Thirty participants will receive either low or high doses of the candidate drug twice daily over a period of 28 days. The study's secondary goals include assessing changes in central subfield thickness and improvements in best-corrected visual acuity post-treatment.”

SaeGwang Park, NexThera’s CEO, expressed, “We are hopeful that the NT-101 clinical trial will demonstrate its potential as a revolutionary therapy for wet AMD and propel further advancements. Additionally, we are investigating its use in other retinal vascular diseases, such as diabetic retinopathy.”

Founded in February 2020, NexThera is a biopharmaceutical research and development entity that leverages platform technology. The company has solidified its presence through collaborations and strategic funding. It has entered joint development agreements with EyeGene Inc. and BMI Korea Co., Ltd., successfully raising a total of KRW 16.3 billion through seed funding, Series A, and bridge round investments.

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According to the data provided by the Synapse Database, As of July 18, 2024, there are 40 investigational drugs for the 11β-HSD1 target, including 41 indications, 33 R&D institutions involved, with related clinical trials reaching 54, and as many as 4241 patents.

The choice of 11β-HSD1 as the target for NTX-101 suggests a strategic focus on the modulation of glucocorticoid metabolism, which may have implications for controlling intraocular pressure and inflammation in the context of glaucoma. NTX-101 to Phase 2 clinical trials represents a significant milestone in its development. Further clinical data and regulatory progress will be important factors to monitor as NTX-101 advances through the drug development process. If successful, NTX-101 has the potential to offer a valuable new treatment option for patients suffering from glaucoma and other eye diseases.