FDA Grants Fast Track Status to Castle Creek’s CCP-020 for Treatment of EBS

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by Diogo Pinto |

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Castle Creek Pharmaceuticals‘ investigational treatment CCP-020 (diacerein 1% ointment) was granted Fast Track designation by the U.S. Food and Drug Administration to treat a type of epidermolysis bullosa (EB) called EB simplex (EBS).

Castle Creek is investigating CCP-020 to treat EBS patients in an ongoing Phase 2 trial called DELIVERS (NCT03154333). The first patient was enrolled in June 2017. The trial is recruiting patients in 20 research centers around the word. Click here to find a study location.

The designation will give the company the opportunity for priority review of the CCP-020 clinical developmental program, and more frequent meetings with the FDA to accelerate the program.

“Fast Track designation is an important milestone in our development program for CCP-020 and reinforces the critical unmet need for patients who are living with the risk of severe blistering and skin erosion associated with EBS,” Amir Tavakkol, PhD, executive vice president and chief development officer at Castle Creek Pharmaceuticals, said in a news release.

“With no approved treatment available, patients may be unable to participate in many daily activities and often experience severe pain. Fast Track designation for CCP-020 brings new momentum to our goal to bring an effective treatment to people living with EBS in the U.S. and around the world,” Tavakkol said.

The FDA had previously granted Rare Pediatric Disease and Orphan Drug designations to CCP-020 for the treatment of EB.

CCP-020 is a small molecule of the class anthraquinone with strong anti-inflammatory properties. Preclinical studies showed that CCP-020 greatly inhibits the production of pro-inflammatory molecules, such as the IL-1β protein.

Topical application of CCP-020 is expected to block the inflammatory response associated with EBS, strengthening the skin tissue and healing blisters.

In a previously completed Phase 2 study that included 17 patients with EBS, 60% of those treated with the CCP-020 cream once a day had at least a 40% reduction in skin blistering after four weeks of treatment, compared to 18% in the control group.

Castle Creek reported adverse events in six patients vs. 11 in the control group, including increased blistering, pruritus and skin infections. However, none of the events was directly associated with the treatment or involved the treatment area.

The company is conducting more clinical trials to evaluate the safety and effectiveness of CCP-020 in EB patients.

A Phase 1 trial (NCT03472287), designed to evaluate the safety and pharmacokinetics (how the drug is processed by the body) of this new formulation, enrolled its first patient in June 2018. The study is expected to recruit up to 20 EBS patients in the U.S. and Europe.

The data from the ongoing trials are expected to contribute to the clinical and marketing development of a CCP-020-based commercial product.