BioCity Biopharma’s selective endothelin receptor type A (ETA) antagonist has reduced excess proteins in the urine of patients with diabetic kidney disease (DKD), hitting a primary endpoint of a phase 2 trial in China.
The therapy, dubbed SC0062, was shown to “significantly reduce” proteinuria among patients who received the highest dose at 20 mg when compared to a placebo cohort at 12 weeks, BioCity said in a press release published Feb. 25.
The Chinese biotech didn’t share any detailed data, only disclosing that the “effect of SC0062 on proteinuria was both clinically meaningful and statistically significant.” A full readout of data at 24 weeks is being saved for an “upcoming scientific conference,” BioCity said.
Most patients received sodium-glucose co-transporter-2 inhibitors and renin-angiotensin-aldosterone system inhibitors as background therapy. SC0062 showed a favorable safety profile in subjects, with no elevated risk of sodium retention compared to the placebo group, the Shanghai-based biotech said.
The 2-SUCCEED trial has a separate cohort of patients with another kidney condition called immunoglobulin A nephropathy (IgAN). This cohort hit its primary endpoint last year of showing a “clinically meaningful and statistically significant” reduction in proteinuria. Specifically, the 5-mg, 10-mg and 20-mg dose cohorts saw geometric mean reductions in 24-hour urine protein-to-creatinine ratio of 39.2%, 33.7% and 48.3%, respectively, compared to 16.5% in the placebo cohort.
BioCity has since launched a phase 3 trial of SC0062 in Chinese patients with IgAN, while a late-stage multiregional study is also in the works.
“SC0062 is a best-in-class, highly selective, small molecule ETA antagonist that has demonstrated efficacy and safety in pre-clinical studies, which have translated into highly favorable therapeutic index in subjects with both IgAN and DKD in a randomized, placebo-controlled clinical study,” BioCity’s co-founder and executive president Ivy Wang, M.D., Ph.D., said in the release.
“We are pleased that SC0062 demonstrated a significant reduction in proteinuria, as well as a favorable safety profile in subjects with DKD and IgAN, which greatly strengthens our commitment to develop SC0062 in CKD,” Wang added.
Novartis is hoping to get its own ETA receptor antagonist approved for IgAN this year. The Swiss pharma secured the therapy, called atrasentan, as part of its $3.2 billion acquisition of Chinook Therapeutics. The FDA has already approved Travere Therapeutics’ Filspari, a dual antagonist of endothelin and angiotensin receptors, for IgAN.