IND clearance for RDD-0315

NEW YORK—RDD Pharma, a specialty pharmaceutical company focused on the development of innovative therapies for anorectal and gastrointestinal disorders, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for RDD-0315. The IND was filed on May 30, 2018. The IND clearance permits the initiation of the RDD-0315 clinical development program, 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 European Medicines Agency has granted RDD-0315 Orphan Drug status in spinal cord injury patients. The Phase 1 clinical study for for RDD-0315 is anticipated to begin in the U.S. in the third quarter, with data anticipated in the fourth quarter of 2018.

“In order to treat diseases in this challenging area, drugs require special formulation and delivery/application techniques to address wide variations in anatomy and physiology.

The anorectal region has unique physiological challenges including high temperature and humidity, frequent passage of stools that scrape the surface and varying absorptive capacity of the various membranes,” says RDD’s website. “Because of these physiological challenges and the high cost of developing new drugs, RDD Pharma has made a strategic decision to concentrate R&D on repurposing existing approved molecules that can be brought quickly and inexpensively to market.”

RDD Pharma also recently announced the appointment of Dr. Mark Sirgo as the Chairman of the Board of Directors in June. Sirgo’s experience with public company leadership from development stage to commercial enterprise will bring additional value to the current board’s expertise and experience, according to RDD.

Sirgo is an executive leader with over 30 years of pharmaceutical industry experience, including the past 13 years as CEO of BioDelivery Sciences, a company focused in pain and addiction medicine. Under Sirgo’s leadership, BDSI went from a preclinical stage to a fully integrated commercial enterprise following the FDA approval of three products during this period. Prior to BDSI, Sirgo spent 17 years at Glaxo, Glaxo Wellcome and GSK in the areas of gastrointestinal, cardiovascular, and respiratory drug development. His career includes 6 years in sales and marketing, including the management of global sales and marketing for PPD. Sirgo has also served on several public company boards, including Salix Pharmaceuticals until its sale in 2015.

“We welcome Mark to our Board of Directors as we move to a company with late clinical stage assets and a growing development pipeline,” said Laufer. “Mark’s experience and insights in the gastrointestinal and OTC arenas will be extremely valuable as our products head forward to commercialization.”