DRGT Announces the U.S. FDA IND Application Approval and First Dosing of a Clinical Trial to Evaluate the Bioavailability and Food Effect of Immediate-Release Formulation of Tadalafil (DRGT-99)

BUDAPEST, Hungary, Sept. 18, 2019 (GLOBE NEWSWIRE) — Druggability Technologies Holdings (DRGT) today announces that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a randomized, single-dose crossover study to evaluate the bioavailability and the impact of food on a novel immediate-release formulation of tadalafil (DRGT-99) compared with 20-mg tadalafil (Cialis®).

A previous phase 1, single-center, dose-ranging trial demonstrated that oral administration of DRGT-99 tablets was associated with a faster time to peak plasma concentration compared to Cialis®. Dr. John Friend, Chief Medical Officer at DRGT, recently noted, “Our initial observations with DRGT-99 are in line with our goal of developing a best-in-class therapy for erectile dysfunction that combines faster onset with a long half-life, while minimizing side effects”.

Erectile dysfunction (ED) is the inability for men to obtain or keep an erection that is firm enough for intercourse. Erectile dysfunction is a common disorder in men over 40 years of age, and can be attributed to conditions that reduce blood flow (diabetes, cardiovascular disease, high cholesterol, nerve damage to name a few). It is estimated that the global ED market will grow substantially due to increasing rates of hypertension, diabetes, and neurologic conditions that affect erectile function, as well as increased patient awareness of treatment options.

Tadalafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), is currently indicated for the treatment of ED, benign prostatic hyperplasia (BPH), concomitant ED and BPH, and pulmonary arterial hypertension. Known for a longer duration of action compared to other options for ED, initial absorption of tadalafil can be variable, with only a minority of men reporting successful intercourse 30 minutes after taking the highest-approved dose of tadalafil. Improved and consistent absorption of tadalafil is an important unmet need for ED therapy. The DRGT-99 formulation has improved the solubility and dissolution of tadalafil in vitro.

This study will enroll healthy male subjects who will receive single doses of DRGT-99 (5 or 15 mg tadalafil) or Cialis® (20 mg tadalafil) with or without food. Results from this study are expected early next year and will be discussed with the FDA.

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.

Cialis® is a registered trademark of Eli Lilly and Company

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