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Argo Biopharma Announces Completion of First Participant Dosing in China Phase I Clinical Study of BW-03, a Novel RNAi Therapeutics for the Treatment of CHB

Jul. 01, 2024

SHANGHAI, July 1, 2024 -- Shanghai Argo Biopharmaceutical Co., Ltd. ("Argo Biopharma"), a clinical-stage biotechnology company focused on developing a new generation of siRNA therapeutics, today announced the completion of dosing for the first participant in a China Phase I clinical study of BW-03 for the treatment of chronic Hepatitis B (CHB) on June 27, 2024. BW-03 is a siRNA drug for the treatment of CHB patients and developed in-house by Argo Biopharma using its proprietary RADS platform technology. Argo Biopharma is conducting global Phase Ib clinical studies of BW-03 in Australia, Hongkong and Thailand, and has completed the enrollment of all participants.

About CHB

Hepatitis B Virus(HBV) infection is one of the most serious infectious diseases threats in the world, with over 254 million people infected globally. CHB is the leading cause of liver disease, resulting in approximately 820,000 deaths annually due to complications. China is a high-prevalence country for CHB, with an estimated total of 87 million infected individuals. Currently, there is a lack of effective drugs for curing CHB.

About BW-03

BW-03 previously has underwent global Phase I clinical trials to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers in a Single Ascending Dosing(SAD) study, as well as its safety, tolerability, pharmacokinetics, and pharmacodynamics in CHB patients in a Multiple Ascending Dose (MAD) study. By December 2023, the Australia SAD clinical trial was completed. Patient enrollment for the MAD study was completed in Thailand and Hong Kong in May 2024. In the same month, a Phase I study was approved by Ethics Committee and was initiated in mainland China.

About Argo Biopharma

Founded in 2021, Argo Biopharma is a clinical-stage biotechnology company committed to developing a new generation of RNAi drugs aimed at providing better treatment options for patients worldwide. In less than three years, Argo Biopharma has established a rich and diverse pipeline of RNAi drug candidates covering a wide range of indications including cardiometabolic diseases, viral infections, CNS and rare diseases. Currently, Argo Biopharma has five RNAi drugs in the clinical stage.

In a noteworthy milestone, Argo Biopharma achieved a strategic partnership with Novartis in January 2024 for $185 million in upfront payments and a total value exceeding $4 billion.

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