MSIDA, Malta, Oct. 05, 2017 (GLOBE NEWSWIRE) — DRGT, a specialty pharmaceutical company, today announced the results of its Phase I study of DRGT18-2, a novel formulation of Sirolimus (Rapamune®), originally a Pfizer product approved by the FDA.
Sirolimus, as developed by Pfizer and approved by the FDA, initially failed to achieve sufficient therapeutic effect in clinical practice due to adverse effects in patients undergoing treatment for prophylaxis of organ rejection receiving renal transplants.
Sirolimus has unfavorable PK properties including low bioavailability and high patient variability. These can be major limitations of its therapeutic utility. As an immunosuppressant, organ rejection shows correlation with low Sirolimus blood levels; and toxicity attributed to over-exposure can often lead to discontinuation. The drug shows positive therapeutic effect in mTOR-responsive malignancies, yet it may not be possible to reach the necessary therapeutic exposure safely and reliably with Rapamune®. This lead DRGT to the development and application of the company’s Super-API drug development platform to the Sirolimus drug.
Phase 1 study results utilizing the new DRGT18-2 formulations may improve patient outcomes by demonstrating a two-fold improvement in therapeutic bioavailability versus patients receiving Sirolimus in clinical practice. Combined with improved bioavailability there was also a substantial reduction in patient variability over the dosage range tested, 0.5 mg to 40 mg.
“We are very excited about these results. DRGT18-2 will greatly enhance and expand the clinical utility of Sirolimus as an effective and safe drug in prophylaxis of organ rejection. DRGT18-2 has the potential to become the new preferred choice over Rapamune® and current calcineurin inhibitors (Cyclosporine A and Tacrolimus). These studies also suggest that DRGT18-2 is a safe and effective option to replace intravenous Temsirolimus and oral Everolimus drugs for the treatment of mTOR-responsive malignancies.” – said Gábor Heltovics, CEO of DRGT.
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.