KoBioLabs has suspended the phase 2a clinical trial of its ulcerative colitis (UC) drug candidate KBL697 (pipeline name: KBLP-007).

KoBioLabs said in a public notice last Wednesday that it had voluntarily withdrawn its phase 2a clinical trial of KBL697. In July 2021, KoBioLab received approval for its phase 2a investigational new drug (IND) trial from the U.S. Food and Drug Administration. This past April, the company received approval for its phase 2a IND from the Ministry of Food and Drug Safety.

Initially, KoBioLabs planned to enroll 30 patients with mild to moderately active ulcerative colitis in 10 clinical institutions in Australia and Korea to evaluate the efficacy and safety of KBL697. Still, recruitment continued to be delayed, according to the company.

The trial suspension will inevitably delay the commercialization of the drug pipeline. KoBioLabs explained that eliminating the pipeline, which is in its early stages, will minimize sunk costs and save at least 5 billion won ($3.9 million) in future development costs.

KoBioLabs has been experiencing a string of bad luck lately. Earlier this month, the company got back the global clinical development, licensing, and commercialization rights of its immune disease treatment candidate KBL382 following a decision by Kolmar Korea Holdings to return the technology. As a result, the technology transfer agreement worth 184 billion won was also canceled.

"In addition to immune diseases, we intend to advance our pipeline by securing candidates for metabolic and central nervous system (CNS) diseases, our strategic therapeutic areas," a KoBioLabs official said. "By being selected as part of the National New Drug Development Project, we are in full swing to develop a complex microbiome obesity treatment using multiple targets."

The company also plans to begin an investigator-initiated trial (IIT) of a microbiome therapeutic aimed at improving the severity of autism spectrum disorders early next year, the official added.