SanReno Therapeutics

Founded in December 2021, SanReno Therapeutics is a clinical-stage biotech focused on kidney diseases and related therapeutic areas. SanReno’s founding investors and partners including Chinook Therapeutics, a leading player in kidney diseases, as well as Pivotal bioVenture Partners China and Frazier Healthcare Partners, both world renown life-science investors. SanReno is committed to the research and development, production and commercialization of drugs in kidney diseases and related therapeutic areas, looks forward to providing innovative clinical solutions to prolong the lives of patients and create a better quality of living for them. Currently, SanReno holds two core assets in the Greater China area and Singapore, including Atrasentan (Phase III) and BION-1301 (Phase II).

Chronic kidney disease is a huge disease burden in Asian population. The prevalence of chronic kidney disease in the Chinese adult population is as high as 10.8%, equivalent to nearly 120 million patients. In China, the incidence of IgA Nephropathy (IgAN) is around 70,000 per year, a number that is significantly higher in Asians than in Europeans and Americans. At present, patients can only be treated with basic renin-angiotensin system (RAS) inhibitors, and the efficacy is not too satisfactory. A large number of patients still progress to end-stage renal disease (ESRD) in 10-20 years after diagnosis, requiring dialysis or kidney transplantation. Currently, there is no approved drug for IgAN in China, representing a huge clinical unmet demand.

One of SanReno’s core assets, Atrasentan is a selective endothelin receptor antagonist which is currently in a global phase III study to evaluate its therapeutic efficacy in IgAN. In a previous global large-scale phase III study （SONAR） of diabetic nephropathy involving more than 5,600 patients, Atrasentan was found that in the context of stable doses of RAS inhibitors, more than half of patients treated with Atrasentan had over 30% decline in proteinuria. After an average of over 2-year follow-up treatment, the annual decline in eGFR in the treatment group was significantly slower and statistically significant compared to the placebo group. At present, Atrasentan is conducting two international multicenter clinical trials. One is a clinical Phase III ALIGN trial for IgAN patients, and the other is a phase II AFFINITY basket trial for multiple nephropathy (including diabetic nephropathy, focal segmental glomerulonephritis/FSGS, Alport syndrome, etc.). The interim result of AFFINITY IgAN cohort was presented at 59 ^thERA-EDTA conference in May 2022, Atrasentan demonstrated 58.5% proteinuria reduction at 24 weeks in patients with IgAN. If Atrasentan is successfully marketed, it will provide new treatment options for patients and broad market prospect with IgAN such as in combination with the standard RAS therapy or SGLT2 treatment.

SanReno’s second core asset, BION-1301, as an anti-APRIL monoclonal antibody which is currently in Phase I/II clinical trial evaluating its efficacy of IgAN. Chinook released the interim data for the Phase I/II trial at the American Society of Nephrology (ASN) meeting in November 2021. 4 of the IgAN patients completed 6-month intravenous injection (450 mg/every 2 weeks) of BION-1301. The data showed about 60% of proteinuria decrease compared with baseline, as well as a 70%-80% decrease in IgA and pathogenic gd-IgA1. The patient tolerated BION-1301 well with no serious adverse events occurred during treatment. Chinook also updated Phase I/II trial with subcutaneous formation and longer follow-up data at 59 ^thERA-EDTA in May 2022, BION 1301 demonstrated a 70.9% geometric mean reduction in 24-hour in six patients at one year treatment. The data shows that BION-1301 has the chance to become an innovative and disease-modifying drug of IgAN, thereby changing the current landscape of limited treatment in IgAN.