Peptide fusion bio-specialized company Nivek is set to officially commence clinical trials for the world's first convergent medical device, a photoresponsive peptide tissue regeneration inducer.
On the 19th, Nivek announced that it received approval for the clinical trial plan (IND) for 'Pepticol EasyGraft' from the Ministry of Food and Drug Safety (MFDS). Nivek plans to conduct domestic clinical trials while simultaneously pursuing product approval from the U.S. Food and Drug Administration (FDA).
In this clinical trial, Nivek aims to demonstrate the efficacy and safety of Pepticol EasyGraft by comparing changes in alveolar bone between Pepticol EasyGraft and absorbable periodontal tissue regeneration inducers. The clinical trial will be conducted with a total of 114 patients at Seoul National University Dental Hospital and Kyung Hee University Dental Hospital.
Pepticol EasyGraft is a functional bio-material that fuses high-purity collagen functional active substances with regenerative functional peptides. Nivek maximized the release and structural stability of peptides by utilizing light as a catalyst. By applying dual-functional peptides that promote tissue regeneration, it not only suppresses periodontitis but also exhibits excellent bone regeneration effects. This product can be used in various fields including dentistry, orthopedics, surgery, and dermatology.
Since 2020, Nivek has been developing Pepticol EasyGraft with research support from the 'Pan-Government Full-Cycle Medical Device R&D Project Group.' During the development process, toxicity tests and preclinical trials were completed in accordance with Good Laboratory Practice (GLP). Patents have been filed for dual-functional peptides and formulation platforms, as well as anti-inflammatory peptide technology, establishing a technological entry barrier. This domestic clinical trial will also be conducted with research funding support from the Pan-Government Full-Cycle Medical Device Project Group and others.
A Nivek representative stated, “Since Pepticol EasyGraft is the first peptide drug fusion material, it has entered clinical trials after passing the stringent clinical trial approval process of the MFDS. We have secured preclinical data comparable to new drug development and proven both safety and efficacy, so the clinical trial is expected to proceed smoothly.”
He added, “From the early stages of development, Pepticol EasyGraft has attracted significant interest not only from global top-tier implant companies but also from global healthcare companies focused on expanding regenerative treatments. We plan to conduct domestic clinical trials alongside procedures for FDA product approval in the U.S., aiming to grow it into a core global market product for the company.”
Nivek is also pursuing FDA clinical trials for the regeneration mechanism-based peptide therapeutic ‘NP-201.’ Global clinical trials are underway for inflammatory bowel disease (IBD) and pulmonary fibrosis (PF), while research and development to expand indications to pulmonary arterial hypertension (PAH) and obesity treatments are also being conducted.
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