SHANGHAI, China I Aug. 24, 2018 I Zai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, today announced the decision to discontinue the development of ZL-3101 (Fugan) for the treatment of atopic dermatitis (AD). This decision was made based on the top-line results of a Phase IIA trial of ZL-3101 in patients with mild to moderate subacute eczema.
The double-blind, randomized, placebo-controlled multi-center Phase IIA study enrolled 295 Chinese patients with AD. Although the study showed that topical ZL-3101 was safe and well-tolerated, the treatment showed no difference compared to placebo in the primary efficacy endpoint, a change in the Eczema Area and Severity Index (EASI) score at day 21.
“Although disappointing, our broad and advanced pipeline enables us to redirect resources allocated to ZL-3101 to our other advanced clinical-stage assets and opportunities,” said Dr. Samantha Du, Zai Lab’s Chief Executive Officer. “ We look forward to providing updates on the progress of our oncology, infectious disease and auto-immune drug candidates.”
About ZL-3101
Fugan (ZL-3101) is a novel steroid-sparing topical product for the treatment of eczema and psoriasis. The Company licensed the exclusive worldwide rights to Fugan in 2016 from GSK.
About Zai Lab
Zai Lab (NASDAQ:ZLAB) is a Shanghai-based innovative biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. The company’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China’s pharmaceutical market and addressing unmet medical needs. Zai Lab’s vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners’ and its own products in order to impact human health worldwide.
SOURCE: Zai Lab
Post Views: 36
SHANGHAI, China I Aug. 24, 2018 I Zai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, today announced the decision to discontinue the development of ZL-3101 (Fugan) for the treatment of atopic dermatitis (AD). This decision was made based on the top-line results of a Phase IIA trial of ZL-3101 in patients with mild to moderate subacute eczema.
The double-blind, randomized, placebo-controlled multi-center Phase IIA study enrolled 295 Chinese patients with AD. Although the study showed that topical ZL-3101 was safe and well-tolerated, the treatment showed no difference compared to placebo in the primary efficacy endpoint, a change in the Eczema Area and Severity Index (EASI) score at day 21.
“Although disappointing, our broad and advanced pipeline enables us to redirect resources allocated to ZL-3101 to our other advanced clinical-stage assets and opportunities,” said Dr. Samantha Du, Zai Lab’s Chief Executive Officer. “ We look forward to providing updates on the progress of our oncology, infectious disease and auto-immune drug candidates.”
About ZL-3101
Fugan (ZL-3101) is a novel steroid-sparing topical product for the treatment of eczema and psoriasis. The Company licensed the exclusive worldwide rights to Fugan in 2016 from GSK.
About Zai Lab
Zai Lab (NASDAQ:ZLAB) is a Shanghai-based innovative biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. The company’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China’s pharmaceutical market and addressing unmet medical needs. Zai Lab’s vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners’ and its own products in order to impact human health worldwide.
SOURCE: Zai Lab
Post Views: 36
