Naibec "New Drug for Pulmonary Fibrosis and Inflammatory Bowel Disease Successfully Completes Phase 1 Clinical Trial in Australia"

Peptide fusion bio-specialized company Nivek announced on the 6th through a public disclosure that it has completed Phase 1 clinical trials of the pulmonary fibrosis treatment ‘NIPEP-PF (clinical trial code NP-201, hereinafter NP-201)’ conducted at the Australian CMAX Clinical Research Center and received the final results report.

As a result of the Phase 1 clinical trial, NP-201 demonstrated excellent safety and tolerability (the degree to which patients can endure side effects) in human trials. Even in clinical trials where the maximum tolerated dose of 400mg was administered, no abnormalities or side effects occurred, confirming the highest level of safety.

NP-201 is a peptide-based pulmonary fibrosis treatment developed by Nivek with a novel mechanism of action. It is evaluated to have overcome the limitations of existing treatments due to its excellent regenerative effects on damaged lung tissue as well as fibrosis inhibition. Global pharmaceutical companies are also paying attention to its new drug development.

Phase 1 clinical trials were conducted on a total of 32 healthy adults, administering the subcutaneous (SC) formulation of NP-201 in combination with a placebo. The administered doses were 100mg, 200mg, 300mg, and 400mg for each patient group.

No serious adverse events (SAE) were observed during the trial period, and adverse events (AE) were mild. Diagnostic tests using blood and urine, vital signs, physical examinations, electrocardiograms, and respiratory function tests all recorded values within acceptable ranges.

Pharmacokinetic (PK) characteristics were also confirmed. As the dose of NP-201 increased, the ‘maximum plasma drug concentration’ and the ‘area under the concentration-time curve (AUC)’ increased proportionally. Additionally, the plasma half-life and elimination rate were maintained within a certain range. As a result, NP-201 showed no abnormalities in absorption, distribution, or excretion even at high concentrations, and the half-life was maintained for an appropriate duration. This indicates rapid absorption and sustained presence in the body, which is one of the advantages of the peptide drugs being developed by Nivek.

A Nivek official stated, “The NP-201 global Phase 1 clinical trial in Australia, conducted to confirm the drug’s safety and tolerability, proceeded smoothly without any issues,” adding, “Based on the Phase 1 results, we are preparing for a Pre-IND meeting with the U.S. Food and Drug Administration (FDA) for Phase 1b/2a clinical trials.”

He continued, “As the efficacy of NP-201’s fibrosis treatment mechanism has been confirmed in regenerative therapy, we plan to expand its indication to inflammatory bowel disease treatment and conduct Phase 1b/2a clinical trials in the U.S.,” emphasizing, “The scope of the new drug’s application is expected to expand further, strengthening its commercial viability.”

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