WUXI, China, June 21, 2023 -- BioCity Biopharma, a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders, today announced the initiation of a randomized, placebo-controlled Phase 2 clinical trial of its novel, oral endothelin A (ETA)-receptor selective antagonist, SC0062, with the enrollment of two patients with IgA nephropathy（IgAN）in China（NCT05687890）. This multi-center study will assess the safety and preliminary efficacy of SC0062 relative to placebo in patients with chronic kidney disease with albuminuria.

The initiation of the Phase 2 trial follows the successful completion of a Phase 1, first-in-human (FIH) trial for SC0062 in healthy volunteers. Clinical data from the FIH study demonstrated a favorable safety profile of SC0062 without reports of the adverse effect of edema in subjects who had received treatment with different doses of SC0062. Currently SC0062 is in Phase 2 clinical development for IgAN and DKD (diabetic kidney disease).  Data from the ongoing randomized phase 2 trial are expected in 2024.

Dr. Yong Jiang Hei, Co-CEO of BioCity, stated that ETA receptor antagonists have emerged as a promising therapeutic approach in the field of CKD, and SC0062 is designed with high selectivity for ETA receptors with the objective of ensuring efficacy while avoiding the potential safety risks associated with other molecules in the same class. Biocity Biopharma intends to expedite the ongoing Phase 2 clinical trial of SC0062 in order to generate the data necessary to allow informed decision-making on further development of SC0062.

About BioCity

Founded in December 2017，BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases (CKD).  The company has established a pipeline of more than 10 innovative drug candidates including small molecules, monoclonal and bispecific antibodies as well as antibody-drug conjugates (ADCs). Currently Biocity Biopharma has 6 oncology projects in Phase 1 development, including agents targeting the DNA damage response (DDR) pathway via a WEE1 and an ATR inhibitor, and agents targeting the immune system with a T cell engager (CD3XEGFR BsAb), an immune checkpoint inhibitor (TIM-3 mAb), and a T cell activator (4-1BB mAb). A FIH study for the novel CDH3-targeting ADC has been initiated with patient enrollment expected in the beginning of the 2H of 2023. In addition, an endothelin A(ETA)-receptor selective antagonist designed for CKD has entered phase 2 development.