MDT-006 product summary
About Constipation and Irritable Bowel Syndrome with Constipation (IBS-C)
While the exact cause of Irritable Bowel Syndrome is unknown, it is estimated that between 20 and 40 million U.S. adults suffer from this disease. While both genders are candidates for IBS, there is a higher incidence among women and sufferers of psychiatric disorders such as depression and anxiety. According to Datamonitor, “IBS is one of the most common functional disorders and is one of the top 10 reasons for visits to primary care physicians.” Symptoms of the disease include constipation, abdominal pain, bloating, and fatigue. Constipation is also a common side effect associated with medications such as opioids and with certain surgical procedures.
Current pharmaceutical options are extremely limited to treat chronic constipation and IBS-C, and there is a substantial commercial opportunity for a safe and effective therapy. MDT-006 offers an attractive approach to current therapy because the compound acts primarily on the colon and is not absorbed. As a result of these attributes it is expected to have fewer gastrointestinal and systemic side effects. Unexpected systemic side effects have plagued formerly marketed therapies for IBS-C, causing them to be pulled from the market. Gastroenterologists are expected to be the key targeted specialist physician audience for this medication.
MDT-006 is a novel, selective, non-absorbed, oral, small molecule and is the lead candidate in a portfolio of molecules acquired from Epix Pharmaceuticals. The compound is extremely potent, possibly allowing for once-a-day dosing, and has demonstrated efficacy and safety in preclinical studies. MDT-006 has many potential uses, including as a treatment for chronic constipation and constipation related to IBS (IBS-C) and to side effects associated with medications and surgical procedures. Because of MDT-006’s unique mechanism of action, it may also have applications for respiratory and ocular indications.
In preclinical animal studies, MDT-006 increased feces production and water content, reduced gastrointestinal transit time and further had no detectable plasma levels. MicroDose will develop this product initially for constipation and IBS-C in an oral format in its proprietary PolyCap® system. In the future, because of MDT-006’s unique mechanism of action, MicroDose may leverage its pulmonary and other delivery systems for applications in non-gastrointestinal diseases.