[Featured Stock] Nivek Draws 'Significant Interest' from Global Obesity Drug Developers... 1.5x Efficacy Compared to SC Formulation

Confirmed Efficacy of Oral Formulation Using Proprietary Drug Delivery Platform
Oral Formulation Included in Global Phase 2 Clinical Trial for Inflammatory Bowel Disease Treatment
"Applicable to Obesity Treatment"

Naivec is showing strong performance. The news that its proprietary drug delivery platform ‘NIPEP-TPP’ demonstrated an efficacy of reducing the ‘Disease Activity Index (DAI)’ by more than threefold in oral formulation research appears to be influencing its stock price. The Disease Activity Index is an indicator used to evaluate or measure the activity level of a specific disease. This index is used in managing inflammatory diseases, autoimmune diseases, or chronic conditions, helping to objectively assess the current state of the disease and evaluate treatment effectiveness.

As of 9:58 AM on the 3rd, Naivec’s stock is trading at 15,480 KRW, up 6.03% from the previous day.

Through the research results, Naivec’s NIPEP-TPP technology has been extended from the existing subcutaneous (SC) formulation to an oral formulation. Starting with treatments for inflammatory bowel disease, Naivec plans to develop oral formulations for obesity treatments and accelerate the incorporation of the NIPEP-TPP platform into various new drugs through joint research with global pharmaceutical companies.

Naivec confirmed that when the NP-201 oral formulation was administered to mouse models induced with acute and chronic inflammatory bowel disease by chemical drugs, the intestinal structure was completely regenerated to resemble that of normal mice. The oral administration also verified an effect of reducing the Disease Activity Index by more than threefold compared to the disease state. This reduction was more than twice that of the existing standard treatment and 1.5 times that of subcutaneous injections.

Naivec plans to include oral formulations in clinical trials alongside existing subcutaneous injections in the global Phase 2 clinical trial for inflammatory bowel disease treatments. Last month, Naivec received approval for Phase 1b/2a clinical trials for inflammatory bowel disease treatments in Australia. Upon completion of the Australian Phase 1b trial, the company plans to apply for Phase 2 trials with the U.S. Food and Drug Administration (FDA) based on the related data to expand the clinical trial countries.

Naivec is expanding the application of NP-201 not only to inflammatory bowel disease treatments but also to obesity, pulmonary fibrosis, and pulmonary arterial hypertension treatments. Since efficacy for the oral formulation was confirmed in inflammatory bowel disease treatments, the company explains that there is a very high possibility of applying oral formulations to obesity treatments and pulmonary fibrosis treatments currently under development with the same active ingredient.

A Naivec representative stated, "Oral formulations of biologics including peptides have significant advantages over subcutaneous injections in terms of convenience, patient compliance, and cost efficiency, but they are affected by gastrointestinal absorption rates and have the disadvantage of low bioavailability." He added, "The oral formulation of the inflammatory bowel disease treatment developed by Naivec not only has superior bioavailability in colon tissue compared to subcutaneous injections but also excels in efficacy, making it a highly valuable technology in the global market."

He continued, "Top-tier global pharmaceutical companies are showing great interest in Naivec’s oral formulation new drugs," adding, "One global pharmaceutical company is focusing on follow-up research for the oral formulation of inflammatory bowel disease treatments, and a world-leading obesity treatment developer is highly interested in whether the oral formulation of peptide-based obesity treatments maintains the same blood concentration."