DRGT Announces Hungarian Regulatory Authority Approval and Subsequent Initiation of a Phase 2 Trial of DRGT-119 in Patients With Chronic Anal Fissure
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.
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.
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