Naivek Verifies Efficacy of 'Oral' Inflammatory Bowel Disease Treatment... "Phase 1 Clinical Trial to Proceed Within the Year"
[Asia Economy Reporter Hyunseok Yoo] NIIVEK, a peptide fusion bio company, has successfully verified the efficacy of 'NIPEP-IBD,' an oral inflammatory bowel disease treatment under development. With this successful efficacy verification, the Phase 1 clinical trial for new drug development is expected to be actively pursued.
NIIVEK announced on the 26th that the efficacy verification of the oral formulation of the inflammatory bowel disease treatment (NIPEP-IBD), conducted in collaboration with the UK bio company 'Intract Pharma,' has been successfully completed.
NIIVEK has been conducting full-scale research activities through a joint research agreement with Intract Pharma in the UK to optimize its independently developed oral inflammatory bowel disease treatment pipeline. NIIVEK supplied the 'top discovery peptide'-based inflammatory bowel disease treatment candidate 'NIPEP-IBD,' and Intract Pharma optimized the oral formulation platform and conducted efficacy verification based on NIIVEK's candidate substance.
A representative from Intract Pharma stated, “NIIVEK's inflammatory bowel disease treatment 'NIPEP-IBD' has already proven efficacy as an injectable and is currently being developed as an oral formulation. Through experiments, stability in the actual colon was confirmed, making the development of the oral formulation successful.”
Existing inflammatory bowel disease treatments mainly inhibit the key inflammatory cytokine 'TNF-alpha,' which ultimately does not significantly improve immune cell activity, resulting in the limitation that therapeutic efficacy cannot be maintained for a long time. This is mainly due to the body's resistance to 'Aminosalicylic acid' and 'Steroid,' meaning that while existing treatments may temporarily alleviate related symptoms, fundamental treatment is impossible.
NIIVEK explained that NIPEP-IBD not only suppresses inflammation but also regenerates the intestinal mucosa, which has been damaged by inflammation, to normal levels, thus being evaluated as a fundamental treatment for inflammatory bowel disease.
A NIIVEK official said, "Recently, regulatory authorities in major countries require confirmation not only of simple inflammation suppression but also of 'intestinal tissue' regeneration ability. Since new drug development with tissue regeneration function is necessary, NIIVEK's inflammatory bowel disease treatment is attracting attention from stakeholders."
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He added, "NIPEP-IBD has already completed preclinical toxicity tests in injectable form, and the oral formulation has been verified through animal experiments to have no difference in efficacy compared to the injectable, so it is highly likely to proceed smoothly to clinical trials. We are conducting additional verification studies with our joint research partner Intract Pharma and are pushing to initiate Phase 1 clinical trials within this year."
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