Naivek Validates Preclinical Efficacy of Pulmonary Fibrosis Treatment... "Urgent Clinical Trial Advancement Planned"

[Asia Economy Reporter Hyunseok Yoo] On the 7th, Nivek announced that among its pipelines under development for fibrosis treatment, the idiopathic pulmonary fibrosis treatment ‘NIPEP-APF19’ demonstrated approximately twice the efficacy compared to existing treatments, based on preclinical animal models and safety tests conducted at European GLP institutions. APF19 not only reduced fibrosis by 80% but also significantly decreased levels of inflammatory cytokines.

This verification was conducted at GLP institutions located in France and Germany, confirming the efficacy of the pulmonary fibrosis treatment through animal models inducing lung fibrosis and safety tests including those on monkeys.

Among the pipelines developed in-house, Nivek holds a lineup of candidate substances for fibrosis treatments including pulmonary fibrosis, cardiac fibrosis, and non-alcoholic fatty liver fibrosis. Among these, the pulmonary fibrosis peptide treatment ‘NIPEP-APF19’ is composed of 19 amino acids.

A company representative stated, “Through this verification, it was confirmed that the mechanism promotes the removal of fibrous (fibrous collagen) tissue in lungs where fibrosis has progressed due to viral and bacterial infections such as COVID-19, chronic diseases, etc., while simultaneously promoting lung cell regeneration. Not only efficacy verification but also safety verification through toxicity tests on monkeys has been completed, securing related preclinical data.”

He added, “We plan to rapidly proceed with the development of the pulmonary fibrosis treatment and promptly complete the IND application, aiming to enter Phase 1 clinical trials by 2021 at the latest.”

Nivek’s fibrosis treatment is expected to have groundbreaking effects not only on existing fibrosis treatments but also on pulmonary fibrosis caused by sequelae of COVID-19 infections, which are spreading worldwide. According to the company, in severe COVID-19 patients, the virus proliferates in the bronchi and lungs, causing pulmonary fibrosis and increasing levels of inflammatory cytokines, making this treatment highly meaningful as an effective therapy.

Nivek has sent the verification data to a European-based global pharmaceutical company with which it has been discussing technical cooperation and technology transfer, and is currently discussing future development schedules. Based on these verification results, the development of fibrosis treatments is expected to gain further momentum.

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