NEW YORK, Sept. 14, 2017 /PRNewswire/ -- RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP) has funded the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application. The grant of $1.28M will enable initial U.S. clinical development of RDD-0315 for fecal incontinence in spinal cord injury patients including preparations for and conducting of a Phase 1 study in healthy volunteers to assess acute tolerance and PK.
"We are pleased the CDMRP recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients," stated Jason Laufer, Chief Executive Officer, RDD Pharma. "We can now move forward more aggressively in the U.S. to develop RDD-0315 which has the potential to positively impact the health, well-being and quality of life in this patient population."
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.
"We look forward to advancing our clinical studies after filing an IND with the US Food and Drug Administration," said Nir Barak, Chief Medical Officer of RDD Pharma. "We are thrilled with the CDMRP's recognition of the potential of a treatment such as RDD-0315 and share their enthusiasm about the 'potential of this drug to decrease the incidence of fecal incontinence in those with spinal cord injury."
About RDD Pharma RDD is a privately held specialty pharma, focused 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 currently in a Phase 3 clinical study in Europe. A Phase 2a study has been completed with RDD-0315 for fecal incontinence in the EU and IND preparations have initiated in the US. 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. Fecal incontinence occurs in 75% of spinal cord injury patients, significantly impacting quality of life. Over 8% of non-institutionalized adults (~20 million) suffer from fecal incontinence in the US. 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.
About the Award The U. S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Spinal Cord Injury Research Program under Award No. W81XWH-17-1-0523. Opinions, interpretations, conclusions and recommendations are those of RDD Pharma and are not necessarily endorsed by the Department of Defense.