LongBio Pharma-B(01779.HK): LP-003 Phase III Trial for Seasonal Allergic Rhinitis Hits Primary Endpoint
Newtimespace (newtimespace.com) reports that LongBio Pharma (Suzhou) Co., Ltd. (1779.HK) announced that the Phase III clinical trial of LP-003 for seasonal allergic rhinitis has reached its pre-specified primary endpoint, with results demonstrating high statistical and clinical significance.
The Phase III trial was a multi-center, randomized, double-blind, placebo-controlled study conducted in China, comparing LP-003 versus placebo in patients with moderate-to-severe seasonal allergic rhinitis inadequately controlled by standard treatment. A total of 546 patients were enrolled and randomized into two groups receiving either 100mg LP-003 or placebo via injection once every four weeks (Q4W). The primary endpoint was clinical efficacy measured by Total Nasal Symptom Score (TNSS) during the pollen peak period (PPP). Secondary endpoints included safety, efficacy (DNSMS and DNOMS), PK, and PD.
LP-003 is an anti-IgE antibody with a novel sequence design targeting allergic diseases including seasonal allergic rhinitis, CSU, allergic asthma, CRSwNP, and food allergy. The Company has obtained IND approvals in China for multiple indications.
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