BioCity's ETA Antagonist Shows Promise in Phase 2 Trial for Diabetic Kidney Disease

BioCity Biopharma has announced positive results from its phase 2 trial of SC0062, a selective endothelin receptor type A (ETA) antagonist, in patients with diabetic kidney disease (DKD). The trial, conducted in China, demonstrated a significant reduction in proteinuria, a key indicator of kidney function, at the highest dose of 20 mg compared to placebo after 12 weeks of treatment.

Promising Results in Proteinuria Reduction

The phase 2 trial, part of the larger 2-SUCCEED study, evaluated SC0062's efficacy in reducing excess proteins in the urine of DKD patients. While specific data points were not disclosed, BioCity reported that the effect on proteinuria was both clinically meaningful and statistically significant. The company plans to present a full data readout, including 24-week results, at an upcoming scientific conference.

Importantly, SC0062 demonstrated a favorable safety profile, with no elevated risk of sodium retention compared to the placebo group. This is particularly noteworthy as sodium retention can be a concern with some kidney disease treatments.

Dual Success in Kidney Disorders

The 2-SUCCEED trial also included a separate cohort of patients with immunoglobulin A nephropathy (IgAN), another serious kidney condition. This cohort previously met its primary endpoint, showing significant reductions in proteinuria across multiple dose levels:

• 5 mg dose: 39.2% reduction
• 10 mg dose: 33.7% reduction
• 20 mg dose: 48.3% reduction
• Placebo: 16.5% reduction

These results have prompted BioCity to initiate a phase 3 trial of SC0062 in Chinese patients with IgAN, with plans for a multi-regional late-stage study in the works.

Competitive Landscape in Kidney Disease Treatment

BioCity's progress with SC0062 places it in a competitive field of kidney disease treatments. Novartis is currently seeking approval for its own ETA receptor antagonist, atrasentan, for IgAN. The Swiss pharmaceutical giant acquired this therapy as part of its $3.2 billion purchase of Chinook Therapeutics.

Additionally, the FDA has already approved Travere Therapeutics' Filspari, a dual antagonist of endothelin and angiotensin receptors, for the treatment of IgAN.

As the pharmaceutical industry continues to focus on addressing serious kidney disorders, BioCity's SC0062 represents a potentially significant addition to the treatment landscape for both DKD and IgAN patients.