Wednesday, July 18, 2018
RDD Pharma, a specialty pharmaceutical company focused on the development of innovative therapies for anorectal and gastrointestinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application. The IND was filed in the US on May 30, 2018. The IND clearance permits the initiation of the clinical development program for RDD-0315, a topical treatment for fecal incontinence in spinal cord injury patients.
"The clearance of this IND represents an important milestone for RDD Pharma and for the over 200,000 patients in the U.S. suffering from fecal incontinence related to spinal cord injury," shared Jason Laufer, Chief Executive Officer of RDD Pharma. "We are excited to be moving RDD-0315 into clinical development in the U.S., building on promising Phase 2a data we obtained in Europe. We believe RDD-0315 has the opportunity to be the first treatment option for patients with spinal cord injury and associated fecal incontinence. In addition, with further clinical study, we have the potential to treat the more than 20 million people in the U.S. with fecal incontinence due to other causes such as aging, diabetes, Alzheimer's, and other neurodegenerative disorders."
Positive Phase 2a results in Europe in evaluating the safety and efficacy of RDD-0315 for the treatment of fecal incontinence in spinal cord injury patients have previously been reported with a statistically significant reduction in the number of fecal incontinence episodes at 8 and 12 hours post-administration.
The Phase 1 clinical study is anticipated to begin in the U.S. in the third quarter with data anticipated in the fourth quarter of 2018.
