Subject: TRI
RDD Pharma Announces IND Clearance to Advance RDD-0315 to Treat Fecal Incontinence in Patients with Spinal Cord Injury
NEW YORK, July 17, 2018 /PRNewswire/ -- 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.
About RDD Pharma
RDD Pharma is a privately held specialty pharma company focused on accelerated development and commercialization of innovative therapeutics for anorectal diseases and lower-gastrointestinal tract disorders. The company has two clinical stage products and two pre-clinical products, all which serve significant unmet needs. RDD-1219 for chronic anal fissure has completed enrollment in a European pivotal Phase 3 study. RDD-0315 for fecal incontinence, an indication for which there is no approved Rx product, has completed a Phase 2a study in Europe. The European Medicines Agency has granted RDD-0315 Orphan Drug status in spinal cord injury patients. Two pre-clinical assets are also in development for pruritus ani and radiation colitis/proctitis.
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.
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. The U. S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. Opinions, interpretations, conclusions and recommendations are those of RDD Pharma and are not necessarily endorsed by the Department of Defense.
Contact:
Jason Laufer
CEO
[email protected]
+1-973-723-9000
Jennifer Filbey, Ph.D.
Business & Corporate Development
[email protected]
+1-256-417-8568
SOURCE RDD Pharma
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