SAN FRANCISCO and SUZHOU, China, April 3, 2022 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the results of a phase 3 clinical trial (Study code: CREDIT-2) of recombinant full-human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent) in Chinese patients with heterozygous familial hypercholesterolemia (HeFH) have been accepted as an abstract presented (E-poster #: 1188-005) at the American College of Cardiology Annual Congress 2022 (ACC 2022).
PCSK-9 inhibitors, which can potently reduce LDL-C levels with a good safety profile, have been gradually recognized by clinicians as novel therapeutic regimens in recent years. Although there are various imported PCSK-9 inhibitors marketed in the Chinese market, there are some limitations in terms of economy and convenience. IBI306 is an innovative drug independently developed by Innovent. It is the PCSK-9 inhibitor that take the lead in carrying out long-term, large-scale, randomized and double-blind phase III clinical studies in China (CREDIT-1, CREDIT-2 and CREDIT-4), and explored and optimized the treatment regimen with long-interval dosing.
The AAC 2022 presentation is based on CREDIT-2, a randomized, double-blind, placebo-controlled phase 3 study, evaluating the efficacy and safety of IBI306 in Chinese patients with heterozygous familial hypercholesterolemia (ClinicalTrials.gov, NCT04179669). During the 12-week double-blind treatment period, patients previously received a stable lipid-lowering therapy for at least 4 weeks were randomized 2:1:2:1 to receive subcutaneous injection of IBI306 or placebo 150 mg Q2W, or IBI306 or placebo 450 mg Q4W respectively. In week 12-24, patients in control groups continued to receive IBI306 with the previous regimens; while…
The post Innovent Releases Results of a Phase 3 Clinical Study of IBI306 (PCSK-9 inhibito… – Press Release appeared first on CaymanMama.com.
from CaymanMama.com https://ift.tt/GFQik4f
No comments:
Post a Comment