CrystalGenomics Applies for Phase 1 Clinical Trial of Fibrosis Treatment Drug Candidate ‘CG-750’

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[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 21st that it has submitted an Investigational New Drug application (IND) to the Ministry of Food and Drug Safety for approval of phase 1 clinical trials of its fibrosis treatment drug candidate ‘CG-750’.

The phase 1 clinical trial is a multiple ascending dose (MAD) study, in which the capsule formulation of the fibrosis treatment drug candidate CG-750 will be repeatedly administered orally to 24 healthy adult males at Seoul National University Hospital. Pharmacokinetics, safety, and tolerability evaluation data will be obtained. The possibility of developing an oral formulation of the anticancer drug to improve medication convenience will also be confirmed. CG-750 is being developed as a treatment for various fibroses, including idiopathic pulmonary fibrosis (IPF).

Developing an oral formulation is expected to improve patient medication convenience and reduce economic burden. Patients can continue treatment through medication in daily life without having to visit the hospital each time. Existing injectable drugs require patients to visit the hospital in person for intravenous administration, which is inconvenient.

CrystalGenomics selected the fibrosis field, which has a high unmet medical need and promising prospects for new drug development, as a target area and established its subsidiary Makaon in July last year. It received 28 billion KRW in external investment. The company plans to increase the success rate of fibrosis drug development and shorten development time.

Previously, in October last year, the phase 1 clinical trial of the single ascending dose (SAD) study was completed.

A Makaon official said, "In the case of idiopathic pulmonary fibrosis, the average survival period after diagnosis is only 2.5 to 5 years," adding, "There are only two approved treatments, Ofev and Esbriet, but there are no treatments with excellent efficacy." He further added, "There are no approved treatments for renal fibrosis, so the unmet need is significant."

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