[Featured Stock] Nivec, Unprecedented Regenerative Inflammation Treatment... Global Pharma Companies Eyeing

Peptide fusion bio company Nivek is showing strong performance. The news that it has successfully completed the pre-IND (Pre-Investigational New Drug) process with the U.S. Food and Drug Administration (FDA) to conduct Phase 1b/2a clinical trials for its self-developed new drug substance ‘NP-201’ as a treatment for inflammatory bowel disease appears to be influencing its stock price. Nivek plans to submit an IND application for NP-201 in the second half of this year.

As of 10:15 AM on the 27th, Nivek is trading at 20,450 KRW, up 9.65% from the previous day.

NP-201 is based on a newly developed peptide with a novel mechanism of action. The company explains that this therapeutic agent is effective in treating inflammation and fibrosis. It not only suppresses inflammation and fibrosis but also regenerates damaged cellular tissues, differentiating it from existing treatments.

Since January this year, Nivek has been conducting pre-consultations with the FDA for the U.S. clinical trials of NP-201 as a treatment for inflammatory bowel disease. Recently, Nivek received a written response from the FDA confirming that the currently held NP-201’s ▲Chemistry, Manufacturing, and Controls (CMC) ▲non-clinical data ▲in vitro/in vivo data are appropriate for the clinical trial application for inflammatory bowel disease treatment. Based on the pre-IND letter received from the FDA, Nivek plans to accelerate clinical preparations.

For the FDA Phase 1b/2a trial, safety must be demonstrated through repeated dosing and a Multiple Ascending Dose (MAD) study in healthy adults. Since October last year, Nivek has been conducting the MAD study for NP-201 in Australia. Because at least three months of GLP repeated-dose toxicity study results are required, preparations for this are also underway.

A Nivek representative said, "Since NP-201 has already succeeded in a global Phase 1 trial as a treatment for pulmonary fibrosis, we expect the FDA clinical trial expanding the indication to inflammatory bowel disease to be successful as well," adding, "We anticipate entering clinical trials including patient dosing as early as this year or at the latest early next year."

He continued, "NP-201 not only enables fundamental treatment of inflammation and fibrosis but has also shown therapeutic effects on pulmonary arterial hypertension through animal experiments, attracting attention from numerous global pharmaceutical companies," emphasizing, "The development of inflammatory bowel disease treatments specialized in regenerative mechanisms is unprecedented and is expected to have a significant market impact."

Earlier, Nivek confirmed safety in preliminary toxicity tests for its next-generation MASH treatment under development. Nivek’s MASH treatment is based on ‘cell reprogramming’ specialized in regeneration and shows excellent effects in reducing liver fibrosis. Through cell reprogramming, it reduces inflammation and fat accumulation in liver tissue and also removes fibrosis. The company explains that this mechanism differentiates it from existing MASH treatments targeting GLP (a hormone that increases insulin secretion) or FGF (fibroblast growth factor, a type of hormone).

At the end of last year, during the government-led ‘Alchemist Project,’ Nivek succeeded in developing an anti-aging reversal peptide. The related technology has also been patented to establish entry barriers.