Naibec Receives Clinical Approval for 10 Trillion KRW Osteoporosis Treatment... "Entering Peptide-Based Clinical Trials"

[Asia Economy Reporter Hyunseok Yoo] Naivek, a bio-specialized company with peptide fusion technology, has received clinical approval for an osteoporosis treatment, marking the official start of new drug development. Naivek is currently in discussions with global pharmaceutical companies regarding the licensing out of its peptide-based osteoporosis treatment and subsequent clinical trials. It is expected that once the results of Phase 1 clinical trials are obtained, discussions related to the new drug will gain further momentum.

On the 5th, Naivek announced that it had received approval for Phase 1 clinical trials of its peptide-based osteoporosis treatment NIPEP-OSS. The Phase 1 trial is scheduled to be conducted at Seoul Asan Medical Center. Naivek will administer subcutaneous injections of NIPEP-OSS (Osseotide acetate), an osteoporosis treatment based on bone formation functional peptides, to healthy adult volunteers to evaluate the drug’s safety and tolerability.

A Naivek official stated, “We have already completed the IRB approval and all ancillary administrative procedures at Seoul Asan Medical Center so that Phase 1 clinical trials can proceed without delay.” He added, “This clinical trial will be conducted as a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study involving 8 subjects per dose group, with a total of 40 participants. Monitoring will continue for about one month after administration.”

Currently, the global population suffering from osteoporosis is estimated to be about 200 million. Additionally, fractures caused by osteoporosis occur approximately once every 3 seconds, resulting in over 8.9 million patients annually. Existing osteoporosis treatments on the market are known to cause serious side effects. Treatments that inhibit bone resorption can cause fatal damage to the esophagus and stomach, as well as jawbone necrosis and femoral fractures.

In contrast, Naivek’s osteoporosis treatment under development is based on bone formation peptides, so it has no side effects. The company explained that preclinical trials testing safety and toxicity on mice and monkeys were completed at the German LPT institute, proving the absence of side effects.

A Naivek representative said, “The company officially submitted the preclinical trial results on July 11 last year, and has now received approval from the Ministry of Food and Drug Safety for Phase 1 clinical trials.” He added, “Once Phase 1 is completed, we plan to proceed with technology transfer or joint research and development for subsequent clinical trials with global pharmaceutical companies.”

He continued, “Since the osteoporosis treatment drug developed by Naivek is based on a substance developed for the first time in the world, the Ministry of Food and Drug Safety conducted a very rigorous review considering all risk factors.” He added, “NIPEP-OSS not only promotes bone formation but also inhibits fat accumulation, making it an effective drug for menopausal women. It is being developed with the goal of global commercialization as well as domestic sales.”

This content was produced with the assistance of AI translation services.