Naibec Presents Inflammatory Bowel Disease Treatment at International Conference... "Selected as FDA Clinical Trial Site"

Naivek announced on the 9th that it will participate in the ‘IBD INNOVATE Conference 2024 (Inflammatory Bowel Disease Conference)’ to present research and development achievements on its self-developed regenerative mechanism inflammatory bowel disease treatment ‘NP-201’. Naivek, which is advancing clinical trials of NP-201 in the United States, plans to conduct networking for selecting clinical institutions through this conference.

The Inflammatory Bowel Disease Conference is a global academic conference held annually by the US 'Crohn's & Colitis Foundation'. Since many scholars researching inflammatory bowel disease treatments worldwide, as well as global pharmaceutical companies and specialized research institutions, participate in large numbers, Naivek expects to narrow down the pool of candidate clinical institutions to conduct FDA clinical trials for NP-201.

At this conference, Naivek will disclose clinical and preclinical trial data on NP-201, a peptide-based regenerative mechanism inflammatory bowel disease treatment. NP-201 has already demonstrated human safety by conducting a global Phase 1 clinical trial last year with an indication for pulmonary fibrosis treatment.

In the global clinical trial, a total of 32 healthy adults were administered subcutaneous (SC) injections of NP-201 combined with a placebo. The dosage was 100mg, 200mg, 300mg, and 400mg for each patient group. The trial results showed that NP-201 had no abnormalities in absorption, distribution, or excretion even at high concentrations, and the half-life was maintained for an appropriate duration.

In preclinical trials, NP-201 also demonstrated excellent efficacy. In chronic animal models, dose-dependent increases in intestinal length, decreases in disease activity, and increases in the expression of mucosal regeneration biomarkers were observed. According to the company, this indicates that NP-201 not only has anti-inflammatory effects but also regenerates damaged cellular tissues, enabling fundamental treatment.

A Naivek official stated, “During the conference, we plan to contact as many specialized inflammatory bowel disease institutions in the US as possible and select clinical institutions optimized for NP-201’s FDA clinical trials among them.” He added, “Since NP-201 possesses a regenerative mechanism differentiated from existing treatments, many clinical institutions are expected to express interest.”