FDA Accepts Koutif Therapeutics’ Investigational New Drug Application for KT-1002

FDA Accepts Koutif Therapeutics’ Investigational New Drug Application for KT-1002

The U.S. Food and Drug Administration (FDA) has accepted Koutif Therapeutics’ investigational new drug (IND) application for KT-1002. The company is set to begin a Phase 1 clinical trial testing the experimental therapy in inflammatory bowel disease (IBD).

The trial will assess how the oral therapy behaves inside the body and if it is safe and effective against IBD. Koutif also expects to determine the optimal dose of KT-1002.

The two most common forms of IBD, ulcerative colitis and Crohn’s disease, develop due to a deregulated immune response against the gut microbiota, causing excessive inflammation. That means compounds that diminish the inflammatory response are potential treatments for these conditions.

KT-1002 is a small immunomodulatory molecule, a compound that alters the body’s immune response, acts as an inhibitor of the protein Fbxo3, an E3 ligase (proteins that regulate the degradation of other proteins).

When KT-1002 blocks Fbox3, it causes an increased degradation of proteins involved with the immune response, especially proteins that trigger inflammation. So, the therapy could help ease the symptoms of not only Crohn’s disease and ulcerative colitis, but also other inflammatory disorders.

There are no approved treatments that block Fbxo3, which suggests that KT-1002 could effectively treat patients who do not respond to current therapies because it controls inflammation through a new pathway.

“Bringing KT-1002 to clinic marks a major milestone for Koutif Therapeutics, capping off years of hard work from our scientific founders,” Baiju R. Shah said in a press release. Shah is 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,” Shah said.

Koutif received an exclusive license for KT-1002 and other potential Fbox3 inhibitors from the University of Pittsburgh and the U.S. Department of Veterans Affairs, which founded the research leading to the discovery of the compounds.

KT-1002 was developed initially by researchers at The Ohio State University College of Medicine and the University of Pittsburgh School of Medicine; both institutions hold equity in Koutif therapeutics.

The company is a biotech start-up that focuses on finding treatments for inflammatory diseases. Its main funder, BioMotiv, is the for-profit accelerator of The Harrington Project for Discovery & Development, a $340 million initiative based in Cleveland that aims to create a bridge between academia and industry by accelerating the time it takes for breakthrough discoveries by research institutions to become therapies available to patients.