HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China [Yahoo! Finance]
HUTCHMED (China) Limited - American Depositary Shares (HCM)
NASDAQ:AMEX Investor Relations:
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Source: Yahoo! Finance
announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China. This follows positive data from the proof-of-concept Phase II stage of the trial and subsequent consultation with the China National Medical Products Administration (“NMPA”). If positive, the data from the trial may be used to support a future New Drug Application (“NDA”) filing. wAIHA is an autoimmune disorder that can lead to anemia and has limited treatment options. The first Phase III patient received their initial dose on March 20, 2024. ESLIM-02 is a randomized, double blind, placebo-controlled Phase II/III clinical trial. The objective of the registration stage of the study is to confirm the safety and efficacy of sovleplenib in adult patients with wAIHA. The primary endpoint for the study is the proportion of patients who achieve a durable hemoglobin (Hb) response by Week 24. 21 patient
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HCM
Sec Filings
- 4/22/24 - Form 6-K
- 4/8/24 - Form 6-K
- 4/5/24 - Form 6-K
- HCM's page on the SEC website