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Koutif Therapeutics Confirms Clinical Candidate Drug

Company Expects to File IND Application in Late 2018

Erin Reese

CLEVELAND AND PITTSBURGH — JULY 20, 2018 —Koutif Therapeutics today announced that KT-1002, which has been selected as its lead compound, has reached clinical candidate status for the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn’s Disease, after successfully completing IND-enabling studies. The biotech start-up’s small molecule oral inhibitor of Fbxo3, an E3 ligase, 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.

“We are very encouraged by the results of the lead compound both in IND-enabling studies as well as in disease models,” said Baiju R. Shah, CEO of BioMotiv and Chairman of Koutif Therapeutics. “Based on the data, we plan to file an IND application by the end of the year.”

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, Professor and Chief of the Pulmonary, Allergy and Critical Care Division at the University of Pittsburgh School of Medicine and Staff Physician at the VA Pittsburgh Healthcare System, 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. This novel mechanism has the potential to treat numerous inflammatory conditions.

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.

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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:

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, or contact the Innovation Institute at