PharmaResearch announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PRD-101, enabling the initiation of a phase-I clinical trial in the United States (US).

PRD-101 is a next-generation nano anti-cancer drug candidate formulated using nucleotide fragments produced through PharmaResearch's proprietary DOT (DNA Optimising Technology). The drug leverages the company's nucleotide-based Advanced DOT drug delivery platform, designed to enable efficient loading of therapeutics and improve pharmacokinetics.

The phase-I clinical trial will be conducted across up to seven clinical sites in the US, and is expected to enroll approximately 90 patients with locally advanced or metastatic solid tumours. The study is designed to evaluate the safety, tolerability and pharmacokinetics of PRD-101.

 "The FDA clearance of our IND application marks an important milestone for PRD-101. Through this phase-I trial, we aim to further characterise PRD-101 and continue advancing our oncology pipeline," the company stated.