Therapy Areas: Autoimmune
FDA Acceptance of Koutif Therapeutics' IND Application for Novel New Treatment of IBD
22 February 2019 - - US-based biotechnology company Koutif Therapeutics' investigational new drug application for KT-1002 has been cleared by the US Food and Drug Administration to begin a Phase 1 clinical trial for the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, the company said.

KT-1002, a first-in-class, orally active, immunomodulatory agent, is a potent and selective small molecule inhibitor of Fbxo3, an E3 ligase that represents a novel target for modulation of inflammatory and immune responses.

The Phase 1 clinical trial will aim to characterize human exposures, metabolism, and safety to inform selection of the optimal dose of KT-1002.

Koutif Therapeutics has exclusively licensed intellectual property, which includes the lead compound KT-1002, from the University of Pittsburgh and the United States Department of Veterans Affairs.

KT-1002 was developed by Rama K. Mallampalli, MD, chair, Department of Internal Medicine, The Ohio State University College of Medicine and Beibei Chen, PhD, Associate Professor of Medicine, director, Small Molecule Therapeutic Center, Co-director, Acute Lung Injury Center of Excellence at the University of Pittsburgh School of Medicine, each of whom hold equity in Koutif Therapeutics and serve as paid consultants to the company.

The intellectual property licensed from Pitt includes several compounds that potently inhibit the novel target Fbxo3. KT-1002 causes degradation of several potent, pro-inflammatory proteins, including multiple proteins involved in adaptive and innate signaling pathways.

The biotech start-up's small molecule oral inhibitor of Fbxo3 also shows promise in the treatment of multiple inflammatory condition targets, including bronchiolitis obliterans syndrome, chronic obstructive pulmonary disease, acute lung injury, and rheumatoid arthritis.

The intellectual property derived from research funded by multiple Department of Veterans Affairs Merit Awards and NIH grants, including the prestigious NIH CADET grant awarded to Dr. Mallampalli in 2014.

Dr. Mallampalli has also received support from Harrington Discovery Institute, which is supported in part by a grant from the Ohio Third Frontier, as a 2016 Harrington Scholar-Innovator.

BioMotiv is an accelerator associated with The Harrington Project for Discovery and Development, a USD 340m initiative for advancing medicine centered at University Hospitals in Cleveland.

The focus is to accelerate breakthrough discoveries from research institutions into therapeutics for patients through an innovative model that efficiently aligns capital and collaborations. The company leverages an experienced team and advisory board to select, fund, and actively manage and advance a portfolio of drug development programmes.

The Harrington Project for Discovery and Development (The Harrington Project) is a USD340 m national initiative built to bridge the translational valley of death. It includes the Harrington Discovery Institute at University Hospitals in Cleveland and BioMotiv, a for-profit, mission-aligned drug development company that accelerates early discoveries into medicines for benefit of society.

The University of Pittsburgh is one of the nation's leading research universities with expertise across a broad range of academic disciplines. The University seeks to achieve positive societal impact through the commercial licensing of innovations developed from sponsored research.

Part of The Ohio State University, one of America's leading research universities, The Ohio State University Wexner Medical Center is one of the most preeminent and diverse academic medical centers in the country and the only academic medical center in central Ohio.

With more than 23,000 faculty and staff, Ohio State's Wexner Medical Center includes: a top-35 College of Medicine; one of only 49 National Cancer Institute, designated comprehensive cancer centers in the country; seven hospitals; a unified physician practice; a network of primary and specialty care practices; more than 20 research centre and institutes; and 25 core laboratories and more than 2,000 active clinical trials in virtually every medical specialty. 

Ohio State's Wexner Medical Center is the only central Ohio hospital listed in "America's Best Hospitals" rankings by US News and World Report. Ten of Ohio State's medical specialties are recognized for excellence in the magazine, deemed one of the country's consumer guides to top-performing hospitals.
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