Bowave Pharmaceuticals Submits IPO Prospectus Highlighting Breakthrough Therapy-Designated siRNA Candidate BW-20507 for Chronic Hepatitis B
Argo
RNAi Drug Developer
On June 3, the CDE website showed that Argo's Class 1 new drug BW-20507 injection is proposed to be included in the breakthrough therapy category, with the proposed indication for...Chronic Hepatitis B Virus Infection。
Screenshot source: CDE official website
BW-20507 is a hepatitis B virus-targeting drug independently developed by Argo.（HBV）Small Interfering RNA in the Messenger RNA S Region（siRNA）Molecule, mainly used for the treatment of chronic hepatitis B.
To be held in May 2025, the European Association for the Study of the Liver（EASL）At the annual meeting, Argo Biopharma announced the Phase I/IIa clinical study data of BW-20507 for the treatment of chronic hepatitis B. The key research data released at the EASL annual meeting showed:
BW-20507 Subcutaneous Injection,Once every four weeks, for a total of three doses, can significantly reduce HBsAg levels in a dose-dependent manner.The maximum reductions observed in the 200 mg and 400 mg dose groups were 2.9~3.2 log₁₀ IU/mL.
In subjects with baseline HBsAg levels below 1,000 IU/mL, 56%(5/9 cases)HBsAg clearance occurred during the study period.
Strong HBV DNA suppression was also observed in treatment-naïve subjects not concurrently receiving NUC therapy.
'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Screenshot source: Insight database
The principal investigator of this study, the presenter at the 2025 EASL Congress, and Professor Mengfeng Yuan from Queen Mary Hospital, The University of Hong Kong, stated, "After only three doses of BW-20507, some patients have already shown HBsAg clearance, which is extremely rare in other siRNA monotherapies. These results bring new hope for functional cure to patients with chronic hepatitis B.。」
Based on these positive results, Argo Biopharma plans to initiate Phase IIb clinical development of BW-20507 in 2025. The monotherapy Phase IIb study is expected to commence in the second quarter of this year, while the combination therapy Phase IIb study is anticipated to start in the third quarter, aiming to further evaluate the potential of BW-20507 in achieving functional cure for chronic hepatitis B.