CrystalGenomics Applies for Phase 2 Clinical Trial of COVID-19 Treatment 'Ivaltinostat'

[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 15th that it has submitted an Investigational New Drug application (IND) to the Ministry of Food and Drug Safety for approval of a Phase 2 clinical trial of ‘Ivaltinostat,’ which is being developed as a treatment for COVID-19.

The Phase 2 clinical trial will evaluate the efficacy and safety of Ivaltinostat in 60 patients with moderate to severe symptoms requiring hospitalization due to Omicron and variant virus infections. The efficacy assessment will focus on patients' clinical recovery time, time to discharge, and time to normalization of oxygen saturation.

Ivaltinostat will be administered three times a week (on days 1, 4, and 7) at 72-hour intervals over one week to confirm clinical effects. If symptoms have not fully recovered, administration will continue every 72 hours for up to four weeks until clinical recovery as defined by the World Health Organization (WHO) is achieved.

All clinical subjects will be followed up for 30 days. Including the dosing period, the total follow-up period will be up to 60 days.

Ivaltinostat is a novel drug candidate developed in-house that induces immune balance by normalizing abnormal immune cell proliferation and activation. It is an anti-inflammatory drug designed to treat acute pneumonia, acute lung injury, and pulmonary fibrosis caused by cytokine storms resulting from coronavirus infection.

A CrystalGenomics official stated, "We also plan to conduct a Phase 2 clinical trial for an oral COVID-19 treatment based on Ivaltinostat."

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