[Asia Economy Reporter Hyunseok Yoo] Naivek, a peptide fusion bio company, announced on the 24th that its pulmonary fibrosis treatment under development has successfully demonstrated excellent therapeutic effects in a secondary efficacy test conducted by a European CRO institution.
This experiment was conducted to verify the efficacy and safety of the pulmonary fibrosis treatment using a bleomycin-induced pulmonary fibrosis animal model and monkeys. The experimental results secured proven data supporting the therapeutic effect on pulmonary fibrosis, and Naivek is currently in discussions for technology licensing with multiple global pharmaceutical companies based on this data.
The European CRO institution that conducted the verification compared Boehringer Ingelheim’s “Ofev,” a well-known idiopathic pulmonary fibrosis treatment, with Naivek’s pulmonary fibrosis treatment candidate “NIPEP-APF.” The efficacy comparison was made by measuring the fibrotic area in lung tissue, and the results showed that Naivek’s NIPEP-APF reduced fibrosis by more than 200% compared to the Ofev treatment group, successfully verifying its excellent pulmonary fibrosis inhibition function.
It was also confirmed that the anti-fibrotic function acts only on the fibrotic lesion tissue where fibrosis occurred, with no effect on normal lung tissue. This means that the drug acts precisely on the targeted area without side effects.
In histopathological examinations conducted following the efficacy verification, it was confirmed through animal models treated with NIPEP-APF that not only was the progression of pulmonary fibrosis suppressed, but the fibrotic lung tissue recovered to a form similar to normal lung tissue. Because it suppresses the expression of fibrosis-related protein genes as well as simply improving symptoms, it is possible to fundamentally heal the root cause.
A Naivek official stated, “Pulmonary fibrosis occurs due to excessive collagen fiber deposition in the lungs caused by external infections or inflammation, and Naivek’s ‘NIPEP-APF’ is based on a mechanism that inhibits this, resulting in excellent therapeutic efficacy without side effects.” He added, “This secondary efficacy test secured significant data supporting superior efficacy through a comparative experiment with Ofev, a well-known pulmonary fibrosis treatment, and under confidentiality agreements, we are conducting in-depth technical discussions with multiple global pharmaceutical companies.”
He continued, “Global pharmaceutical companies are interested not only in injectable formulations but also in developing oral and inhalation formulations, and tests for these are planned. Some pharmaceutical companies expect that ‘NIPEP-APF’ will have synergy with a COVID-19 treatment currently being developed as an inhalation formulation.” He added, “In severe COVID-19 patients, the virus proliferates in the bronchi and lungs causing pulmonary fibrosis, and inflammatory cytokine levels increase, so ‘NIPEP-APF’ is being evaluated as an effective treatment.”
Naivek plans to proceed with an IND for the pulmonary fibrosis treatment candidate and will accelerate preparations for phase 1 clinical trials based on this verification experiment.
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