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Science & Innovation

 

Sucampo’s commitment to science and pharmaceutical innovation has yielded a robust pipeline across many research areas, with upcoming clinical milestones.

 
 

Pipeline

We are working to accelerate the development of additional formulations of lubiprostone, while at the same time developing therapies that have the potential to treat a variety of other diseases or conditions, with a focus on therapeutic areas where significant unmet or underserved needs exist.

 

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Clinical Focus

Stage of Clinical Development Completed

Lead Compounds

Pre-Clinical

Phase 1

Phase 2

Phase 3

Lubiprostone - Pediatric Functional Constipation (6 years - 17 years)

Lubiprostone for pediatric functional constipation is being investigated for children 6 years to 17 years of age. Constipation is one of the most common gastrointestinal complaints in children. Constipation in children has similar characteristics to that of constipation in adults in that symptoms include infrequent bowel movements, hard stools, large diameter stools and painful passage of stools.

For more about our clinical trials in this area, please visit:

https://clinicaltrials.gov/ct2/show/NCT02042183

https://clinicaltrials.gov/ct2/show/NCT02138136

Lubiprostone - Alternate Formulation

An alternate formulation of lubiprostone is being investigated for additional adult and pediatric patients who cannot tolerate capsules or naso-gastric, tube fed patients. This alternate formulation will be used in the pediatric functional constipation program for children 6 months to 6 years in age. Constipation is characterized by the infrequent or difficult passage of stool. Chronic constipation is idiopathic (of unknown or spontaneous origin) if it is not caused by other diseases or by use of medications.

Lubiprostone - Pediatric Functional Constipation (6 months - 6 years)

Lubiprostone for pediatric functional constipation is being investigated for children 6 months to 6 years of age. This program will use the alternate formulation. Constipation is one of the most common gastrointestinal complaints in children. Constipation in children has similar characteristics to that of constipation in adults in that symptoms include infrequent bowel movements, hard stools, large diameter stools and painful passage of stools.

CPP-1X/sulindac Combination Product

Sucampo entered into an exclusive option and collaboration agreement with Cancer Prevention Pharmaceuticals (CPP) in January 2016. Sucampo was granted the sole option to acquire an exclusive license to commercialize CPP-1X/sulindac combination in North America. This product is currently in a phase 3 clinical trial for the treatment of familial adenomatous polyposis (FAP). A genetic disease, FAP typically develops into colon cancer if left untreated. FAP has been designated an orphan indication in the U.S. and Europe, with a prevalence of about 1 in 10,000, and approximately 30,000 cases in the U.S. There are currently no approved treatments for FAP and no other products in late-stage development.

VTS-270

VTS-270 is a well-characterized mixture of 2-hydroxypropyl-b-cyclodextrin (HPβCD) with a specific compositional fingerprint that distinguishes it from other HPβCD mixtures. Preclinical and early clinical studies suggest that the administration of VTS-270 may slow or stop certain indicators of NPC disease. The ongoing Phase 2b/3 study is a prospective, randomized, double-blind, sham-controlled trial of VTS-270. The randomized portion of the trial concludes a year after the full enrollment of the study.

Contact Us
 
Tel: +1-301-961-3400
 

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of specialized medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA, its lead product, and RESCULA – and a late-stage pipeline of product candidates in clinical development for orphan disease areas. VTS-270 is a mixture of 2-hydroxypropyl-B-cyclodextrins with a specific compositional fingerprint that has been granted orphan designation in the U.S. and Europe and is in a pivotal Phase 2/3 clinical trial for the treatment of Niemann-Pick Disease Type C-1. Sucampo has an option for the North American rights to CPP1- x/sulindac, which is in Phase 3 development for the treatment of familial adenomatous polyposis and has been granted orphan drug designation in the U.S. A global company, Sucampo is headquartered in Rockville, Maryland, and has operations in Japan and Switzerland.