CrystalGenomics Completes Pre-IND Application for COVID-19 Treatment with US FDA

[Asia Economy Reporter Hyunseok Yoo] CrystalGenomics announced on the 1st that it has applied for a Pre-IND meeting with the U.S. Food and Drug Administration (FDA) on the 29th (local time) for the development of a COVID-19 treatment using 'Ivaltinostat'.

The Pre-IND meeting is conducted to discuss the clinical phase 2 and overall new drug development trial plans and is the first step for clinical trial approval.

Before submitting the Investigational New Drug (IND) application, this procedure involves reviewing and coordinating the development status of the new drug candidate with the U.S. FDA, including whether the clinical plans and designs are appropriate for the indication and whether sufficient data for human clinical trials have been secured.

For this meeting, CrystalGenomics submitted numerous data obtained from the Ivaltinostat clinical trials, including the clinical phase 2 protocol synopsis for COVID-19, suitability as a treatment, Investigator’s Brochure (IB), and data related to toxicity and pharmacological effects.

Following the Pre-IND meeting, CrystalGenomics plans to submit the clinical trial plan (IND) for the new drug candidate 'Ivaltinostat' to the FDA for COVID-19 treatment development and to promptly commence phase 2 clinical trials in the U.S. upon approval.

Ivaltinostat is a new drug candidate independently developed by CrystalGenomics that treats inflammation caused by cytokine storms resulting from coronavirus infections, acute pneumonia, and fibrosis occurring as sequelae of COVID-19.

A CrystalGenomics official stated, “We have been diligently preparing additional data to prove the potential of Ivaltinostat as a COVID-19 treatment,” and added, “We will proceed with the IND application following the results of the Pre-IND meeting.”

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