Bowave Pharmaceuticals Doses First Healthy Subject in Phase I Trial of BW-40202, a siRNA Therapeutic Targeting Complement Factor B for Complement-Mediated Diseases

On June 25, Argo Biopharma announced that its investigational small interfering RNA (siRNA) drug BW-40202 has been completed.Phase I Clinical TrialFirst Healthy Subject Dosed with BW-40202Drug Targeting Complement Factor B (CFB) for the Treatment of Complement-Mediated DiseasesThis milestone was achieved at the Australian Clinical Research Center. In addition, BW-40202 has received the approval for new drug clinical trial (IND) from the National Medical Products Administration (NMPA) of China and will be advanced synchronously at clinical research centers in China.

BW-40202 is an siRNA drug targeting CFB mRNA in the liver. Through the RNA interference (RNAi) mechanism, it inhibits the expression of CFB mRNA, thereby reducing serum CFB protein levels and suppressing complement alternative pathway (CAP) activity. In preclinical studies, BW-40202 demonstrated excellent purity and stability, significantly reduced serum CFB protein levels, effectively inhibited CAP activity, and exhibited long-lasting effects and good safety. This first-in-human trial will evaluate the safety, pharmacokinetics, and biomarker changes of BW-40202 in healthy subjects. Preclinical study data support the potential of this therapy as an innovative treatment for complement-mediated diseases.

"This milestone event advances our mission to develop precision RNAi therapies for complement system diseases," said Dr. Dongxu Shu, co-founder and CEO of Argo Biopharma. "By silencing CFB at the genetic level, we aim to provide targeted treatment options for patients with complement-mediated diseases who have significant unmet medical needs."

Public information shows that the complement system is a key component of the immune system. Overactivation or dysregulation of the complement system can lead to various serious diseases, including complement-mediated kidney diseases, complement-mediated hemolytic anemia, age-related macular degeneration, and others. Currently, treatment options for such diseases are very limited and lack specificity, creating an urgent need for innovative precision-targeted therapies.

Argo is a clinical-stage biotechnology company dedicated to developing a new generation of RNAi therapies, providing better treatment options for patients worldwide. The company leverages its liver-targeting and extrahepatic delivery technology platforms to build a diversified RNAi drug R&D pipeline covering cardiometabolic diseases, specialty diseases, viral infections, central nervous system disorders, and rare diseases. Currently, Argo has six RNAi candidate drugs in clinical trials.

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