RDD Pharma Announces Additional Positive Results in a Double-Blind Placebo-Controlled Phase 2a Study in Fecal Incontinence

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Jan 07, 2016, 08:16 ET

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NEW YORK, Jan. 7, 2016 /PRNewswire/ -- RDD Pharma announced today positive results in evaluating the safety and efficacy of RDD-0315 for the treatment of fecal incontinence. The study was conducted in patients with spinal cord injury. A statistically significant 25% reduction in the number of fecal incontinence episodes at 8 and 12 hours post-administration was observed in patients treated with RDD-0315 compared to placebo in the cross-over study, meeting the primary efficacy goal. Good tolerability and safety was also observed, with no systemic absorption as indicated by plasma levels of RDD-0315 being below detectable limits.

"We are thrilled with the positive results of this Phase 2a study and the potential of a treatment such as RDD-0315 for patients who suffer from fecal incontinence," said Nir Barak, Chief Medical Officer of RDD Pharma. "We are looking forward to advancing our studies in a Phase 2b program later this year."

About RDD Pharma

RDD is a privately held specialty pharma company, backed by Orbimed. RDD focuses on fast-track development and commercialization of innovative therapeutics for anorectal diseases and gastrointestinal disorders. RDD Pharma's lead product for the treatment of pain associated with anal fissure is starting Phase 3 in Europe in Q1 2016. RDD-0315 for fecal incontinence is in the midst of Phase 2b preparations. Products currently under development at RDD are expected to reach the market in two to six years.

About Fecal Incontinence

Fecal Incontinence results from damaged or weakened anal sphincter muscles. Treatment options are very limited. It is a condition that can occur at any age and is often devastating to a person's quality of life. For older people, fecal incontinence often results in early institutionalization because family members have difficulty coping with the problem at home.

Over 8% of non-institutionalized adults (~20 million) suffer from fecal incontinence in the US. The average annual direct cost of fecal incontinence in the US is estimated to be over $17,000 per person. Loss of bowel control causes embarrassment, humiliation and significantly impacts quality of life for hundreds of millions of patients globally. Currently, there are no prescription Rx therapies available for treating fecal incontinence.