BUDAPEST, Hungary, July 15, 2019 (GLOBE NEWSWIRE) -- Druggability Technologies Holdings (DRGT) today announced the start of a phase 2 randomized, double-blind, placebo-controlled trial to evaluate the optimal dose of DRGT-119 for the treatment of chronic anal fissure (CAF). DRGT-119 is an enhanced topical formulation of amlodipine, a calcium channel blocker (CCB).

Anal fissure is a longitudinal tear or defect in the skin of the anal canal that can be acute (if present for less than six weeks) or chronic (if present for more than six weeks).  CAF is similar to an ischemic ulcer, initiated and perpetuated by hypertonia of the anal sphincter, resulting in restricted blood flow to the lining of the anus. Anal fissures are commonly caused by hard stools and/or constipation, as well as chronic diarrhea, childbirth trauma in women, anal sex, and inflammatory bowel disease. There are approximately 250,000 to 345,000 new anal fissure cases diagnosed per year in the US, with the treatment market expected to reach $2.6 billion by the end of 2023.

An effective intervention to heal CAF should lower anal sphincter tone, thereby restoring blood flow to ischemic tissue, which in turn improves wound healing and reduces pain. Amlodipine, a long-acting dihydropyridine derivative in a tablet formulation, is FDA-approved to treat high blood pressure based on its ability to relax vascular smooth muscle.  “We are extremely excited to be launching this phase 2 study in patients with chronic anal fissures,” Gábor Heltovics, CEO of DRGT, notes. “Today, there is a significant lack of effective treatment options prior to surgical interventions. There is one FDA-approved topical therapy, a nitroglycerine-based formulation, which is poorly tolerated due to significant adverse events, including headaches, and concerns about use with certain vasodilators.”

Trial design.  This trial will evaluate the efficacy and safety of topical DRGT-119 applied over 6 weeks in subjects with active CAF. Up to 120 patients will be randomized into either one of two DRGT-119 dose groups (0.1% or 0.2% amlodipine) or a placebo group (1:1:1 ratio). Efficacy will be evaluated based on reduction of internal anal sphincter pressure, wound healing, improvement in pain, and patient-reported outcomes.  Subjects who do not achieve healing at 6 weeks will be eligible for an additional 6-week cycle of open-label treatment with 0.2% DRGT-119. Additional safety and tolerability data will be collected during this second cycle of DRGT-119 treatment. EudraCT identifier: 2019-000853-30. Upon completion of this trial, DRGT will work with the FDA and EMA regarding next steps for DRGT-119 development.

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.

Gábor Heltovics, CEO 
E-mail: info@drgtco.com 
Phone: +36-1-5779-300 
http://www.drgtco.com