Amplia Therapeutics secures FDA fast track status for narmafotinib in pancreatic cancer, stock surges

Amplia Therapeutics Limited (ASX: ATX) has announced that its Focal Adhesion Kinase (FAK) inhibitor, narmafotinib, has been granted Fast Track Designation by the United States Food and Drug Administration (FDA). This designation, aimed at expediting the development of drugs intended to address unmet medical needs in serious conditions, could provide an advantage in treating advanced pancreatic cancer.

The Fast Track Designation allows Amplia to benefit from more frequent communications with the FDA, accelerating the clinical development process and bringing narmafotinib closer to potential regulatory approval. The company may also be eligible for additional benefits, including Accelerated Approval and Priority Review, should clinical data support the drug’s efficacy.

Amplia’s CEO and Managing Director, Dr Chris Burns, emphasised the importance of this development, stating that this designation will enable the company to collaborate more closely with the FDA and gather key evidence for regulatory approval. The announcement marks a significant milestone for the company as it continues to develop treatments for devastating diseases like pancreatic cancer.

Narmafotinib has previously been granted Orphan Drug Designation by the FDA, further highlighting its potential role in treating this challenging condition. Amplia is already conducting its ACCENT trial in Australia and South Korea, testing the safety and efficacy of narmafotinib in combination with standard chemotherapies gemcitabine and Abraxane. Meanwhile, the company’s Investigational New Drug (IND) application for a U.S. clinical trial of narmafotinib has been cleared by the FDA, and the trial is now in advanced planning stages.

Narmafotinib (AMP945) has demonstrated promising results in preclinical studies as a potent and selective FAK inhibitor, a protein overexpressed in various cancers, including pancreatic tumours. This ongoing Phase 2a trial aims to further assess the drug’s potential in combating one of the most aggressive forms of cancer.

Amplia Therapeutics, based in Australia, is focused on developing a pipeline of FAK inhibitors targeting cancers and fibrosis. The company is specifically concentrating on fibrotic cancers, such as pancreatic and ovarian cancer, while also exploring the broader role of FAK in chronic conditions, including idiopathic pulmonary fibrosis.

Following the Fast Track Designation news, Amplia Therapeutics’ stock has surged on the Australian Securities Exchange (ASX), gaining 4.76% to reach AUD 0.11. The stock has seen an overall year-to-date increase of 39.74%, buoyed by investor optimism over the company’s progress. Market sentiment remains positive, supported by early clinical results from the ACCENT trial, which reported a 38% patient response rate at the four-month mark. Investors are closely watching upcoming regulatory milestones that could further boost Amplia’s market performance, including potential Accelerated Approval and Priority Review for narmafotinib.