Amplia Pharma Bags US FDA Nod To Begin Clinical Trial of FAK Inhibitor

Amplia Therapeutics Limited reported that the US FDA has approved Amplia's IND application for a pancreatic cancer trial using their best-in-class focal adhesion kinase (FAK) inhibitor, narmafotinib. The proposed trial will investigate the safety, tolerability, and efficacy of a combination of narmafotinib and the chemotherapeutic regimen Folfirinox.

The company is currently undertaking a phase 2a clinical trial of narmafotinib, in combination with two chemotherapy drugs, gemcitabine and Abraxane, in advanced pancreatic patients in Australia and South Korea. In contrast, the IND application reviewed by the US Food and Drug Administration (FDA) supports the use of narmafotinib in combination with a different chemotherapy called Folfirinox (a four drug regimen), which is widely employed in the US for the treatment of pancreatic cancer, as per pharmabiz.

The IND document is a detailed dossier that includes all preclinical and clinical data for narmafotinib, as well as thorough CMC (chemistry, manufacturing, and controls) information. The final paper was almost 10,000 pages long and marked a significant undertaking for the organization during the previous months.

Amplia CEO and MD Dr Chris Burns commented: "Clearance of the IND by the US FDA is a significant step forward for the company. We will now start planning the combination trial of narmafotinib with Folfirinox in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor. Folfirinox is the preferred treatment for pancreatic patients in the USA and most of Europe, and therefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer."

Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis.