DRGT Announces First Subject Dosed in a Phase I Clinical Trial of DRGT-45, a Novel Formulation of Abiraterone Acetate for Prostate Cancer

BUDAPEST, Hungary, Oct. 29, 2019 — Druggability Technologies Holdings (DRGT) today announces the first subject dosed in a two-part Phase I trial to evaluate the pharmacokinetics, safety, and oral bioavailability of DRGT-45 (abiraterone acetate tablets for oral suspension) to treat 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.”

About 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 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.

Forward-Looking Statements
In the interests of providing Druggability Technologies’ or its subsidiaries’ (together, the “Company”) potential partners and investors with information regarding the Company, including the Company’s objectives, goals and strategies, certain statements included in this material may constitute forward-looking information or forward looking statements (collectively, “forward-looking statements”). All statements contained herein that are not clearly historical in nature are forward-looking, and the words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective” and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements.

By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. The Company cautions readers not to place undue reliance on these statements as a number of important factors, many of which are beyond the Company’s control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company’s pipeline; changes in government regulation or regulatory approval processes; government and third-party player reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel.

The foregoing list of important factors that may affect future results is not exhaustive. When reviewing the presented forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. The Company does not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by the Company or on its behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.

Zytiga® is a registered trademark of Janssen Biotech, Inc.

Lynne Powell, CEO
E-mail: [email protected]
Phone: +36-1-5779-300