Capository. (Credit: RDD Pharma, Ltd.)
U.K.-based Quay Pharma, a privately owned company focused on drug delivery and other pharmaceutical services, has developed a specialized filling system to enable a new treatment for anorectal diseases to enter Phase 3 clinical trials.
The Capository from RDD Pharma, Ltd. 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 the new specialized filling system, 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 to run a second Phase 3 study to support U.S. registration of the Capository.
“The Phase 2a study showed a statistically significant reduction in fecal incontinence with one daily topical treatment,” Jason Laufer of CEO of RDD Pharma, said. “Quay Pharma has been instrumental in helping us move this exciting clinical development forward.”
RDD, which maintains offices in New York City and Tel Aviv, Israel, lists its strategic focus as developing products that address unmet patient needs, doctors will prescribe, and payers will reimburse. Its primary focus is on fast-track development and commercialization of therapeutics for anorectal diseases and gastrointestinal disorders.
Quay, established in 2002, operates from facilities in England and Wales. Its technologies include conventional dosage forms, drug solubilization and bioavailability enhancement, controlled release and gastrointestinal targeting, and live biotherapeutics.
The company, which aims to increase its mark in early stage drug development, has created new products for more than 100 clients, across a spectrum of projects ranging from hard-to-deliver new chemical entities to reformulations of established drugs, many successfully licensed or in the latter stages of clinical development.
(Sources: Quay Pharma; RDD Pharma)
