Press release
Ulcerative Colitis Pipeline Analysis, 2016
Ulcerative colitis is an inflammatory condition of colon, in which ulcer is formed in the colon lining. In ulcerative colitis, inflamed colon develops small number of open lesion, that produce pus and mucous. The abnormal response of the immune system causes inflammation in the colon.The ulcerative colitis pipeline has more than 45 drugs. In pipeline analysis, drugs are analyzed based on route of administration and molecule type. The pipeline is also analyzed based on monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, phase I and Preclinical stage.
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Phase III & Filed
Phase III clinical trial known for the comparison of new treatments with the standard treatment in which safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. After the completion of Phase III stage, the company files New Drug Application to the regulatory authorities. Pfizer Inc., is developing Tofacitinib, a Phase III drug candidate for the treatment of ulcerative colitis and psoriatic arthritis. The drug is marketed for rheumatoid arthritis in the U.S. with brand name Xeljanz and it is filed for the approval for same indication in Europe. Tofacitinib targets the intracellular signaling pathways that lead to inflammatory response.
Phase II
Apremilast, a phase II drug candidate of Celgene Corporation for ulcerative colitis is already marketed for the treatment of plaque psoriasis and psoriatic arthritis under the brand name OTEZLA. Apremilast, is an orally administered small-molecule, acts as an inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). Phase II clinical trial take around 2 years to complete and between 100 – 120 patients participate in the phase II trial.
Phase I
Seres Therapeutics is developing SER 287, a bacterium based therapeutic, as an oral capsule for the treatment of ulcerative colitis. SER 287, an Ecobiotic drug comprised of a complex and diverse bacterial spore ecology is being developed using Seres' proprietary microbiome therapeutics platform. The company has collaborated with Nestle Health Science for development and commercialization of SER 287 and other product outside of the U.S. and Canada. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.
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Preclinical
RBX8225, a drug candidate of Rebiotix, Inc., is being developed for inflammatory bowel disease and ulcerative colitis. In October 2016, Rebiotix, Inc., received US patent No. US9433651 from the United States Patent and Trademark Office for its patent application entitled, "Microbiota Restoration Therapy (MRT), Compositions and Methods of Manufacture." The patent covers MRT compositions and methods for manufacturing, processing and delivering the compositions, and builds on Rebiotix's patent issuances in Australia and Canada. Preclinical study is also known as animal study. It is done before testing a drug in people to find out the toxicity profile of the drug. Preclinical study is of two types, including in vitro and in vivo.
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Pipeline analysis provides description about the key companies developing ulcerative colitis drugs. Some of the key players actively involved in the research and development are Celgene Corporation, Pfizer, Inc., Seres Therapeutics, Inc., Ogeda SA, Rebiotix, Inc., Eli Lilly and Company, GlaxoSmithKline plc and Takeda Pharmaceutical Company Limited.
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