DRGT Announces First Subject Dosed in a Phase I Clinical Trial of DRGT-45, a Novel Formulation of Abiraterone Acetate for Prostate Cancer
DRGT-45 (abiraterone acetate), is a second-generation prostate cancer therapy therapy that inhibits the production of testosterone, which is implicated in the growth of prostate cancer, through blockade of CYP17. All currently available formulations of abiraterone acetate necessitate ingeston of multiple large tablets.
The objective of DRGT’s discovery program was to develop an abiraterone acetate formulation with increased solubility in water, leading to improved oral bioavailability and diminished impact of food on abiraterone absorption compared to currently available formulations. In addition to these attributes, DRGT-45 has the potential to eliminate the pill burden for patients receiving abiraterone therapy, particularly for individuals who have difficulty swallowing (dysphagia). An estimated 20+% of the general population suffer from this condition.
This open-label Phase I trial is conducted under an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). The first part of the trial will evaluate the pharmacokinetic profile of a single-dose DRGT-45 using a dose escalation protocol. The second part will compare oral bioavailability of a single DRGT-45 dose to a single dose of Zytiga® in both the fed and fasted states. Dr. John Friend, Chief Medical Officer at DRGT, commented, “Our data suggests that DRGT-45 can mitigate the impact of food and allows for significant dose reduction while achieving a more predictable drug absorption.”
DRGT is a specialty pharmaceutical company dedicated to the development and commercialization of high-value proprietary drugs that deliver measurable and meaningful improvements in clinical utility. DRGT utilizes its proprietary Super-API drug development platform to rapidly select, screen and develop drugs with enhanced pharmacokinetics, which could lead to improved efficacy and safety. The Company’s Super-API portfolio contains 30 compounds across a variety of indications and are protected by global composition of matter Intellectual Property. The company was founded by Dr. Ferenc Darvas, who is also the Chairman of the oldest Hungarian upstream-technology network.
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Zytiga® is a registered trademark of Janssen Biotech, Inc.