According to a new research report “Ulcerative Colitis Therapeutics Pipeline Analysis, 2017 – Clinical Trials & Results, Patent, Designation, Collaboration and Other Developments” published by P&S Market Research, ulcerative colitis currently exhibits a strong pipeline with approximately 89 drug candidates.
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Ulcerative Colitis Pipeline Analysis
The ulcerative colitis pipeline analysis report covers approximately 89 drug candidates, of which 68 drug candidates are in active stage. Among the active drug candidates, one drug is in NDA filed stage, 11 are in Phase III stage, 28 are in Phase II stage, 13 are in Phase I stage, 14 are in Pre-Clinical stage and one drug is in Discovery stage of development. The development of 18 ulcerative colitis drug candidates is found to be inactive and three drug candidates are discontinued.
Ulcerative colitis is a chronic inflammatory disease, which basically affect colonic mucosa. The main identified symptoms of the disease are bloody diarrhea, abdominal cramps and fatigue. Some of the other symptoms include, fever, vomiting, anorexia, abdominal distension and bloating. The treatment approaches to this disease mostly include the use of small molecules and monoclonal antibodies, which are being developed to target and reduce the inflammatory mediators. The treatment of ulcerative colitis includes tumor necrosis factor inhibitors, such as adalimumab, golimumab and infliximab.
Pipeline Insights
The pipeline for ulcerative colitis was analyzed based on route of administration, molecule type and phase of drugs. Based on route of administration, around 46.0% of the active pipeline drug candidates of ulcerative colitis are being developed to be administered by oral route and 29.0% by are being developed to be administered by intravenous and subcutaneous route. Approximately 3.0% drug candidate are being administered by parenteral route, and 4.0% drug candidates are administered by intravenous; subcutaneous route. The route of administration of 29.0% drug candidates is undisclosed. The route of administration of 18.0% drug candidates are being administered by intravenous infusion, rectal, topical and others.
Several pharmaceutical companies engaged in the development of the ulcerative colitis drug candidates include, but are not limited to, Novartis Pharmaceuticals, EA Pharma Co., Ltd., Celgene Corporation, Galapagos NV, Lipid Therapeutics GmbH, and Momenta Pharmaceuticals, Inc.
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Positive clinical results of ulcerative colitis drug candidate
The ulcerative colitis drug candidates have shown positive results of clinical trials. Among them, Lipid Therapeutics GmbH had presented the Phase II results (NCT01011322) of LT-02, a controlled release formulation of phosphatidylcholine for ulcerative colitis. The result showed that LT-02 met the primary end point, change in Simple Clinical Colitis Activity Index (SCCAI) for patient’s refractory to standard first-line intervention who were treated with LT-02 at 0.8g four times a day (51% reduction with LT-02 vs 33% reduction with placebo p <0.05).
Major companies collaborate for the development of ulcerative colitis pipeline
The research found that different companies are engaged in the collaboration for ulcerative colitis. In June, 2015 Lycera Corp. and Celgene Corporation collaborated for cancer and immune-mediated disease pipeline. The key programs of this pipeline include LYC-30937 EC for the treatment of ulcerative colitis. Celgene obtained the exclusive right to acquire Lycera upon conclusion of the option period or achievement by Lycera of pre-specified clinical milestones. During the option period, Lycera retained full control of its research and development programs. Under the terms of the agreement, Lycera received an $82.5 million upfront cash payment. The upfront payment included an exclusive option for Celgene to license Lycera’s portfolio of ex vivo RORg agonist compounds.
Novel and patented technologies for ulcerative colitis pipeline
The novel technologies are being used for ulcerative colitis drug candidates. Protalix Ltd. is using ProCellEx technology platform for their drug candidates. ProCellEx technology platform overcomes the weaknesses by offering significant production, regulatory and cost benefits. Protagonist Therapeutics, Inc. is using peptide technology platform for their drug development. The technology uses series of tools and methods, to discover and develop structurally new oral or injectable peptides. 4D Pharma is using MicroRx technology platform for the development of their drug candidates. The MicroRx technology platform is used to rapidly select those bacteria that have a therapeutic effect in specific diseases.
Some of the key players developing ulcerative colitis therapeutics include EA Pharma Co., Ltd., Celgene Corporation, InDex Pharmaceuticals AB, F. Hoffman-La Roche AG, Sigmoid Pharma Ltd., Pfizer, Inc., Momenta Pharmaceuticals, Inc., Johnson & Johnson, Arena Pharmaceuticals, Inc., and Novartis AG.
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