Latest Hotspot

The phase 2 clinical trial of Otsuka/Visterra's anti-APRIL monoclonal antibody, sibeprenlimab, for the treatment of IgA nephropathy is published in the NEJM

8 November 2023
3 min read

Recently, Otsuka Pharmaceutical and Visterra announced that the complete results of Phase II clinical trials of sibeprenlimab (VIS649) for the treatment of Immunoglobulin A (IgA) nephropathy have been published in the New England Journal of Medicine (NEJM) and presented at the 2023 American Society of Nephrology (ASN) Kidney Week.

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

Sibeprenlimab (VIS649) is an antibody against a proliferation-inducing ligand (APRIL). APRIL is a cell factor that stimulates the abnormal production of IgA, and VIS649 has been shown to bind and block the function of APRIL, which may help treat IgA nephropathy. The drug was initially developed by Visterra. In 2018, Otsuka Pharmaceutical announced its acquisition of Visterra for approximately $430 million, thus obtaining a range of products under development for conditions including IgA nephropathy and other kidney diseases, including VIS649. VIS649 is not yet available in any country or region. Otsuka is conducting an international multicenter Phase III clinical trial to evaluate the efficacy and safety of the drug in patients with IgA.

The study results show that after 12 months of treatment with sibeprenlimab, patients with IgA nephropathy had a significant reduction in proteinuria compared with placebo treatment. At the 12-month mark, compared to baseline, the geometric mean ratio of the 24-hour urine protein/creatinine ratio (UPCR) in patients receiving 2, 4, and 8 mg/kg doses of sibeprenlimab and placebo decreased by 47.2%, 58.8%, 62.0%, and 20.0%, respectively. Compared to the placebo group, the estimated glomerular filtration rate (eGFR) also showed beneficial changes in the sibeprenlimab group. The annual changes in eGFR for patients receiving 2, 4 and 8 mg/kg sibeprenlimab and placebo were -2.7, +0.2, -1.5, and -7.4 ml/min/1.73m2, respectively. This indicates that patient's eGFR tended to stabilize after using sibeprenlimab, on contrary, eGFR declined after using placebo. Among patients treated with sibeprenlimab and placebo, the incidence of adverse events related to treatment (TEAE) was similar. During the trial and the subsequent follow-up period till the 16th month, there was no evidence of adverse toxicities or clinically significant immunosuppression in the safety assessment of sibeprenlimab.

According to information disclosed by the Synapse database, as of November 7, 2023, there are 11 drugs under development targeting APRIL, with 25 indications, 24 research institutions involved, 104 related clinical trials, and up to 31,654 patents. Among the drugs under development targeting APRIL, besides Otsuka's VIS649, Chinook Therapeutics' BION-1301, Yakon Bio's APRIL CAR-T therapy, and Alpine Immune Sciences' APRIL/BAFF dual antibody have also entered the clinical research stage. We look forward to subsequent developments in this target track.

Biological Glossary | What is Intron?
Bio Sequence
2 min read
Biological Glossary | What is Intron?
8 November 2023
An intron, derived from the term "intragenic region", is a nucleotide sequence within a gene that does not directly code for proteins and does not remain in the final mature mRNA molecule following the gene's transcription.
Read →
The first participant has been administered HG004 in an international phase 1/2 study against hereditary blindness, as disclosed by Huidagene Therapeutics
Latest Hotspot
3 min read
The first participant has been administered HG004 in an international phase 1/2 study against hereditary blindness, as disclosed by Huidagene Therapeutics
8 November 2023
HuidaGene Therapeutics, a global oncology-focused biotech company, has announced its first treatment in its multinational HG004 gene therapy study (STAR study). This phase 1/2a investigation uses CRISPR-influenced programmable genomic drugs to potentially treat inherited retinal dystrophies caused by RPE65 gene mutations.
Read →
Patent Analysis of Jiangsu Hengrui's PARP1 Inhibitor HRS-1167
Hot Spotlight
6 min read
Patent Analysis of Jiangsu Hengrui's PARP1 Inhibitor HRS-1167
8 November 2023
In late October, Hengrui and Merck agreed on a €1.4 billion transaction, with a first payment of €160 million. The deal mainly involves Hengrui's self-developed PARP1 inhibitor HRS-1167 and Claudin-18.2 ADC SHR-A1904.
Read →
Prazepam Unveiled: A Detailed Overview of its Revolutionary R&D Breakthroughs
Drug Insights
4 min read
Prazepam Unveiled: A Detailed Overview of its Revolutionary R&D Breakthroughs
17 November 2023
This article summarized the latest R&D progress of Prazepam, the Mechanism of Action for Prazepam, and the drug target R&D trends for Prazepam.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.