CG Invites Completes Phase 1 Trial of Idiopathic Pulmonary Fibrosis Treatment Candidate

Candidate Substance 'Ivaltinostat'

CG Inbites announced on the 7th that its subsidiary Makaon has completed the Phase 1 clinical trial of the idiopathic pulmonary fibrosis (IPF) treatment candidate 'Ivaltinostat.'

CG Inbites CI. [Image provided by CG Inbites]

This Phase 1 clinical trial was a multiple ascending dose (MAD) study conducted at Seoul National University Hospital, where Ivaltinostat capsule formulations of 50, 100, 200, and 300 mg were repeatedly administered orally to 32 healthy adult males, followed by evaluation of pharmacokinetics (PK) and adverse reactions.

The company is currently analyzing data for each dosage to prepare the clinical study report (CSR) following the completion of the trial. Through this, the optimal dosage for the Phase 2 clinical trial will be selected.

CG Inbites explained that the development of an oral formulation is expected to improve patient convenience and reduce economic burden. This is because patients can continue treatment through medication in daily life without having to visit the hospital every time.

Fibrosis occurs through a series of processes in which fibroblasts differentiate into myofibroblasts due to external stimuli. The epigenetic regulator 'Ivaltinostat' has shown efficacy in various disease animal models by converting abnormal diseases such as acquired fibrosis back to normal, according to the company.

Idiopathic pulmonary fibrosis refers to the formation of scars in specific areas of the lungs, causing them to harden. It gradually induces fibrosis in the lung interstitium of unknown cause, with an average survival period of only 2 to 3 years. Currently marketed and used drugs only slow the progression of the disease, and severe side effects often make continued treatment difficult.

In January, Ivaltinostat for the indication of idiopathic pulmonary fibrosis received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA).

Meanwhile, according to Value Market Research, the idiopathic pulmonary fibrosis market recorded sales of $2.3 billion (approximately 3 trillion KRW) in the major seven countries in 2018. This market is expected to grow at an average annual rate of about 10.5%, reaching sales of $3.5 billion (approximately 4.67 trillion KRW) by 2025.

A CG Inbites official said, "We expect objective data confirming the appropriate dosage selection and safety for Phase 2 through the Phase 1 CSR."

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