SWATAR, MALTA--(Marketwired - Dec. 9, 2016) - DRGT, a specialty pharmaceutical company announced today the Phase I clinical results of its DRGT-45 program, a new composition of Abiraterone Acetate - a major drug in the fight against metastatic, castration-resistant prostate cancer.
DRGT-45, a novel Super-API composition was developed by DRGT to eliminate the pharmacokinetic issues associated with the marketed drug. Zytiga® requires high-dose administration (1,000 mg daily) under strict fasted conditions due to a very significant (10-fold) food effect and high variability.
In a Phase I clinical study DRGT-45 improved exposure four-fold, eliminated the food effect and significantly reduced patient variability. The results demonstrated that the same therapeutic effect as Zytiga® can be achieved but at a significantly reduced dose (~ 250 mg). With DRGT-45, Abiraterone plasma levels can be safely increased above 1000 ng/ml where the inhibition of multiple enzymatic pathways is expected to result in even greater therapeutic efficacy.
"We are very excited about this result. It has the potential to offer real improvements in patients' quality of life and in therapeutic outcomes at higher drug exposures that are possible today. We are advancing DRGT-45 to pivotal studies. DRGT has 30 candidates in its preclinical and clinical pipeline" - said Gabor Heltovics, CEO.
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 carefully select and screen drugs and develop their Super-API compositions. The Company's Super-API portfolio contains 30 compounds in indications such as oncology, pain and erectile dysfunction with multi-$ billion potential. Super-API drugs are protected by global composition of matter IP.
DRGT is incorporated in Ireland with R&D facilities in Budapest, Hungary.
The corporation was founded by Dr. Ferenc Darvas, Chairman of the oldest Hungarian upstream-technology network.