Naibec to Advance Clinical Trials of Pulmonary Fibrosis Treatment in Australia

[Asia Economy Reporter Hyungsoo Park] Peptide fusion bio company Nivek is set to actively pursue global clinical trials for one of its major pipelines, a treatment for pulmonary fibrosis.

Nivek announced on the 13th that it has submitted the Investigational New Drug (IND) application for the Phase 1 clinical trial of the pulmonary fibrosis treatment ‘NIPEP-PF (NP-201)’. Nivek will conduct the global Phase 1 clinical trial of NP-201 at the CMAX clinical trial center in Australia, targeting 32 healthy adults aged 18 to 60.

The trial will assess pharmacokinetic properties, safety, tolerability, and immunogenicity. CMAX is the most experienced clinical trial center in Australia, specializing in early-stage clinical trials, located in the Adelaide region of southern Australia.

Since the clinical trial is being conducted in Australia, Nivek expects significant synergy in technology transfer discussions with global pharmaceutical companies and subsequent clinical trials. Australia is a global bio-cluster with many clinical research centers specializing in early-stage clinical trials, such as Phase 1 and 2. This allows for rapid clinical progress and the collection of clinical data from diverse ethnic groups due to the country’s immigration characteristics.

The pulmonary fibrosis treatment NP-201, for which Phase 1 clinical trials have been applied, fundamentally blocks collagen production, the cause of pulmonary fibrosis, thereby halting disease progression. It is a novel treatment with a differentiated mechanism that restores fibrotic lung tissue to a form similar to normal tissue.

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