Qurient Expands Adricetinib cGvHD Clinical Trials to Europe, Accelerates Global Development

On July 29, innovative drug developer Qurient announced that it has submitted a Clinical Trial Application (CTA) and Investigational Medicinal Product Dossier (IMPD) to the European Medicines Agency (EMA) to initiate a clinical trial in Europe for Adricetinib (Q702), its candidate treatment for chronic graft-versus-host disease (cGvHD).

This is a strategic decision to accelerate the global development of a cGvHD treatment by expanding development to Europe, in addition to ongoing clinical trials in the United States. Europe boasts the world’s most advanced unrelated hematopoietic stem cell donor registration system. The incidence of GvHD after transplantation is high, providing a favorable environment for recruiting clinical trial patients.

cGvHD is a chronic inflammatory and fibrotic disease that occurs in 30 to 70 percent of patients who undergo allogeneic hematopoietic stem cell transplantation. There is a high unmet medical need for new mechanism therapies, as many cases do not respond to existing treatments.

In 2023, US-based Syndax received FDA approval for Niktimvo™ (a CSF1R antibody therapy) as a treatment for cGvHD, introducing CSF1R inhibition as a new therapeutic mechanism.

Qurient’s Adricetinib is an oral therapy that offers greater convenience compared to the intravenous Niktimvo. It not only effectively improves the main causes of cGvHD, such as inflammation and fibrosis, but also has the potential to treat residual hematologic malignancies, which are the underlying primary cancers. Thanks to these features, Adricetinib has attracted significant interest and encouragement for clinical development from key opinion leaders in cGvHD treatment.

Nam Kiyeon, CEO of Qurient, stated, "Expanding clinical trials to Europe is a strategic decision to maximize the global competitiveness of Adricetinib and accelerate its development by leveraging the optimal environment for cGvHD clinical research." He added, "The differentiated triple mechanism of Adricetinib is very encouraging, as it demonstrates the potential to target both cGvHD and residual hematologic malignancies simultaneously."