Quay Pharma has developed a specialised filling system to enable a new treatment for anorectal diseases to enter Phase 3 clinical trials.
The Capository™ from RDD Pharma is a proprietary delivery system for the precise delivery of drugs that target conditions and diseases of the anorectal region. It allows directly controlled and precise application of medication to the anal canal region. The company has completed recruitment of a pivotal European Phase 3 study in chronic anal fissure.
Prior to Quay’s involvement, the only solution available to fill the drug into the Capository™ was manually. This would have been an extremely slow process as 70,000 units were required for the initial trials. The team at Quay worked to develop a suitable filling process that would allow for accuracy, speed, efficiency and reproducibility.
Quay Pharma has delivered in excess of 40,000 Capositories™ to support RDD’s clinical development programs. Looking to the future, RDD is planning on running a second Phase 3 study to support US registration of the Capository™.
“The Capository™ provides an elegant solution to treat pain associated with anal fissure,” explains Jason Laufer of RDD Pharma. “The Phase 2a study showed a statistically significant reduction in fecal incontinence with one daily topical treatment.
“Quay Pharma has been instrumental in helping us move this exciting clinical development forward.”