Koutif Therapeutics Announces FDA Acceptance of IND Application for Novel New Treatment of IBD

CLEVELAND--()--Koutif Therapeutics today announced that its investigational new drug (IND) 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 (IBD), including ulcerative colitis and Crohn’s Disease. 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.

“Bringing KT-1002 to clinic marks a major milestone for Koutif Therapeutics, capping off years of hard work from our scientific founders,” said Baiju R. Shah, CEO of BioMotiv and Chairman of Koutif Therapeutics. “We are excited to move this promising new compound forward in the hopes that it will provide an innovative new treatment option for patients living with Crohn’s Disease and other forms of IBD.”

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.

Click here to learn more about Koutif Therapeutics.

About BioMotiv

BioMotiv is the mission-driven accelerator associated with The Harrington Project for Discovery & Development, a $340 million 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 programs.

For more information, go to: www.biomotiv.com.

About The Harrington Project for Discovery & Development

The Harrington Project for Discovery & Development (The Harrington Project) is a $340 million 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.

For more information about The Harrington Project and the Harrington Discovery Institute, visit: www.HarringtonDiscovery.org.

About University of Pittsburgh

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. To learn more about Pitt innovations available for licensing visit www.innovation.pitt.edu, or contact the Innovation Institute at innovate@pitt.edu.

About The Ohio State University Wexner Medical Center

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 (NCI)–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 centers 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 U.S. News & World Report. Ten of Ohio State’s medical specialties are recognized for excellence in the magazine, deemed one of the country's leading consumer guides to top-performing hospitals. For more information, visit www.wexnermedical.osu.edu.


Erin Reese

Release Summary

Koutif Therapeutics’ IND application has been cleared by FDA to begin a Phase 1 clinical trial for the treatment of IBD.


Erin Reese