Koutif Therapeutics Confirms Clinical Candidate Drug

Koutif Therapeutics 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.