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SHANGHAI, Oct. 14, 2024 /PRNewswire/ -- BioCity Biopharma announced that a late-breaking clinical trial abstract of its endothelin receptor type A (ETA) selective antagonist SC0062 has been selected for oral presentation at ASN Kidney Week 2024 which will take place from October 23 to 27 in San Diego, USA. The outstanding clinical data will be published simultaneously in JASN, the leading kidney journal in the world. The abstract titled "SC0062, a New Selective Endothelin Receptor Type A Antagonist in lgA Nephropathy" will be presented by Dr. Hiddo Lambers Heerspink from the University Medical Center Groningen. The details of presentation as below: Oral Abstract Session Session Title：Late-Breaking Science Orals -2 Session Date/Time：October 26,2024 from 4:30PM to 6:00 PM Session Room: Room 6C (Convention Center) Abstract Publication #：SA-OR103 Presentation Time: 5:30 PM to 5:40 PM SC0062 has been granted the Breakthrough Therapy Designation (BTD) by the Chinese regulatory agency National Medical Products Administration (NMPA) for the treatment of IgA Nephropathy (IgAN) with proteinuria. The randomized double-blind, placebo-controlled Phase 2 trial of SC0062 (2-SUCCEED) demonstrated a clinically meaningful and statistically significant reduction in proteinuria in IgAN with a clear dose-response relationship and good safety profile. The 2-SUCCEED study is ongoing for the diabetic kidney disease (DKD) cohort with results are expected in the near future. Currently, BioCity is planning Phase 3 clinical trials of SC0062 in China and worldwide intended for regulatory approval of SC0062 for IgAN as well as for the chronic kidney disease (CKD). About SC0062 SC0062 is a novel and highly unique ETA antagonist due to its high selectivity for ETA over endothelin receptor B (ETB). The high ETA selectivity suggests that it has a greater potential than non-selective ET antagonists for reducing progression of CKD while avoiding the safety risks associated with other nonselective molecules in the same class. Preclinical studies have shown that SC0062 improves pathological scores in models of acute kidney injury and CKD. In the completed Phase I study, SC0062 demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. Fluid retention, an adverse event associated with non-selective ET antagonists due to undesirable ETB blockade, was not observed in the phase 1 trial in healthy volunteers nor in the IgAN cohort of the Phase 2 study. SC0062 is potentially a best-in-class ETA selective antagonist. The ongoing Phase 2 clinical study is designed to evaluate the efficacy and safety of SC0062 in patients with CKD with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts (IgAN and DKD). The 2-SUCCEED study has fully enrolled all subjects in two cohorts. The primary endpoint in the IgAN cohort was met and based on this result SC0062 has granted BTD from NMPA and will be published in JASN, whereas the study is ongoing in the DKD cohort, and the results are expected in Q4 of this year. 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 CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC). Currently, BioCity's SC0062, a highly selective ETA antagonist, is in Phase 2 clinical development for CKD and a global Phase 3 registration trial is being planned. In addition, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca. For more information, please visit Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The European Commission has approved Johnson and Johnson’s Yuvanci for pulmonary arterial hypertension, offering the first single-pill treatment option to European patients. Credit: andreswd via Getty Images. The European Commission (EC) has approved Johnson and Johnson’s Yuvanci (macitentan + tadalafil) for the treatment of pulmonary arterial hypertension (PAH). The approval marks Yuvanci as the only single-tablet combination therapy available for patients with PAH. PAH is a rare, progressive disorder in which patients have high blood pressure in the pulmonary arteries for no apparent reason. Current treatment for PAH involves first-line dual combination therapy with macitentan and tadalafil for patients without cardiopulmonary comorbidities. This currently consists of a multi-pill regimen. “This can deeply impact their [PAH patients’] daily lives as they might struggle to maintain adherence to their treatment regimen,” said Dr. Tamara Werner-Kiechle, the Europe, Middle East, and Africa (EMEA) therapeutic area lead for neuroscience and cardiopulmonary drugs at Johnson & Johnson Innovative Medicine in a 30 September press release. Johnson and Johnson has developed the Yuvanci as a substitution therapy for the long-term treatment of PAH in adults of the World Health Organization’s (WHO) Functional Class (FC) II to III. This includes patients with PAH that causes a slight limitation in physical activity, yet they are still comfortable at rest, and “patients with marked limitations to physical activity”, as per WHO. Patients will need to have already been treated with a two-pill combination of macitentan and tadalafil to be eligible for Yuvanci. Johnson and Johnson currently markets macitenan monotherapy under the brand name Opsumit, whilst Eli Lilly sells tadalafil as Cialis for PAH. The approval is based on data from the Phase III A DUE study (NCT03904693) , which also led to a positive recommendation for Yuvanci’s approval by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products in July. The pharmaceutical giant presented data from the Phase III A DUE clinical study at the American College of Cardiology’s 72nd Annual Scientific Session. In the double-blind study, Yuvanci-treated patients showed significant improvements in the co-primary endpoints of pulmonary vascular resistance (PVR) and pulmonary haemodynamic improvement. Patients who took the combination therapy demonstrated a 44% decrease in PVR compared to a 22% decrease in the Adcirca monotherapy group. See Also: Almac Group North American Headquarters Expansion, Pennsylvania, USA LOTTE BIOLOGICS’ East Syracuse Pharmaceutical Manufacturing Facility, US Opsumit is an endothelin receptor antagonist that treats PAH by inhibiting pathways related to vasoconstriction, fibrosis and proliferation. Meanwhile, Cialis is a phosphodiesterase type-5 inhibitor that treats the disorder by increasing cGMP, leading to a relaxation of the pulmonary vascular smooth muscle cell and vasodilation of the pulmonary vascular bed. Johnson and Johnson submitted a new drug application to the US Food and Drug Administration (FDA) for Yuvanci in May 2023, receiving an approval for its submission in March 2024.

SHANGHAI, Sept. 26, 2024 /PRNewswire/ -- BioCity Biopharma (BioCity) announced its endothelin receptor type A (ETA) selective antagonist SC0062 has been granted the Breakthrough Therapy Designation (BTD) by National Medical Products Administration (NMPA) for the treatment of IgA nephropathy (IgAN) with proteinuria. The BTD for SC0062 was granted based on the outstanding results in subjects with IgAN and proteinuria participating in a randomized double-blind, placebo-controlled Phase 2 trial known as 2-SUCCEED. The main objective of the 2-SUCCEED trial was to evaluate the efficacy and safety of SC0062 in individuals with two types of chronic kidney disease (CKD), IgAN and diabetic kidney disease (DKD). Treatment of IgAN with SC0062 resulted in a clinically meaningful and statistically significant reduction in proteinuria with a clear dose-response relationship and good safety profile. Peripheral edema occurred at a much lower rate in SC0062-treated subjects compared to that in the placebo group. Additionally, for subjects who were receiving concurrent treatment with SGLT2 inhibitors, the combination of SC0062 and SGLT2 inhibitors resulted in a favorable safety profile. These results will be presented at an upcoming scientific conference. The study is still ongoing in the DKD cohort, and these results are expected in Q4 of this year. As one of the most common primary glomerular diseases worldwide, many individuals with IgAN will progress to end-stage renal disease (ESRD) within 10 to 20 years, requiring renal dialysis or kidney transplantation. While developing novel treatments for CKD, especially IgAN, has become a global focus, there remains an unmet medical need for more effective and tolerable therapeutics that can be administered safely for many years to reduce the risk of progression to ESRD. In recent years, several studies have demonstrated that endothelin receptor antagonists can improve renal blood flow, reduce proteinuria, and alleviate inflammatory and fibrotic processes, making them a promising therapeutic option for treating IgAN and other forms of CKD. SC0062 is a novel, highly selective ETA antagonist designed for CKD and the results from a Phase 1 study of SC0062 in healthy volunteers and subjects with IgAN in the 2-SUCCEED study have demonstrated its potential to be the "best-in-class" endothelin antagonist in the treatment of IgAN or CKD. Currently, BioCity is planning Phase 3 clinical trials of SC0062 in China and worldwide with the objective of registering and marketing the agent in IgAN, DKD and other types of CKD. About SC0062 SC0062 is a novel and highly unique ETA antagonist due to its high selectivity for ETA over endothelin receptor B (ETB). The high ETA selectivity suggests that it has a greater potential than non-selective ET antagonists for reducing progression of CKD while avoiding the safety risks associated with other nonselective molecules in the same class. Preclinical studies have shown that SC0062 improves pathological scores in models of acute kidney injury and CKD. In the completed Phase I study, SC0062 demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. Fluid retention, an adverse event associated with non-selective ET antagonists due to undesirable ETB blockade, was not observed in the phase 1 trial in healthy volunteers nor in the IgAN cohort of the Phase 2 study. SC0062 is potentially a best-in-class ETA selective antagonist. The ongoing Phase 2 clinical study is designed to evaluate the efficacy and safety of SC0062 in patients with CKD with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts (IgAN and DKD). The trial is led by Professor Jianghua Chen, Director of the Kidney Disease Center at the First Affiliated Hospital of Zhejiang University School of Medicine and former Chairman of the Chinese Medical Association Nephrology Branch. The study is being conducted at over 40 study sites nationwide. The 2-SUCCEED study has fully enrolled all subjects in two cohorts. The primary endpoint in the IgAN cohort was met and based on this result SC0062 has granted BTD from NMPA, whereas the study is ongoing in the DKD cohort, and the results are expected in Q4 of this year. 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 CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC). Currently, BioCity's SC0062, a highly selective ETA antagonist, is in Phase 2 clinical development for CKD and a global Phase 3 registration trial is being planned. In addition, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca. For more information, please visit Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED