RDD Pharma announces the receipt of a $1.28 million grant from the Department of Defense (DOD) to help enable US clinical development of RDD-0315 to help treat fecal incontinence in spinal cord injury (SCI) patients.
The grant, from the DOD office of the Congressionally Directed Medical Research Programs (CDMRP), is funding the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application.
The development of RDD-0315 includes 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,” says Jason Laufer, chief executive officer, RDD Pharma, in a media release. We can now move forward more aggressively in the US 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, the release explains.
“We look forward to advancing our clinical studies after filing an IND with the US Food and Drug Administration,” states Nir Barak, chief medical officer at 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.”
[Source(s): RDD Pharma, PR Newswire]