latestprogress
recently,salubris announced that its phase ib clinical trial of recombinant fully humananti-pcsk9 monoclonal antibody injection (project code: sal003) has completeddata unblinding and obtained preliminary statistical analysis results.
sal003, independently developed by salubris and its subsidiariessalubris (chengdu) biotech co., ltd and salubris (suzhou) pharmaceutical co.,ltd, is intended to be used for the treatment of hypercholesterolemia and mixedhyperlipidemia.
in the future, salubris will continue to develop more innovativeand good drugs to provide more medical options for patients with chronicdiseases.
about clinicaltrial
thisphase i clinical study was conducted to evaluate the safety, tolerability, andpharmacokinetics of different dosing regimens of sal003 combined with atorvastatinin multiple subcutaneous injections.
thetrial was led by professor yang guoping, the chairman designate of the drugclinical trials special committee of the chinese pharmacological society andprofessor huang zhijun, the director of the chinese hypertension alliance andthe third xiangya hospital of central south university.
theresults showed that compared with the positive control 420mg (q4w) evolocumaband placebo, sal003 showed good safety and tolerance after multiple doses.
in patients with hypercholesterolemia and mixedhyperlipidemia who had been taking statin lipid-lowering therapy for at least 4weeks, it has shown a trend of reducing serum low-density lipoproteincholesterol (ldl-c) and improving other blood lipid indicators in 140mg (q4w)and 420mg (q8w) sal003 group.
relatedinfo
dyslipidemia characterized by elevated ldl-c or triglycerides isan important risk factor for atherosclerotic cardiovascular disease (ascvd).
both domestic and foreign guidelines for the prevention andtreatment of dyslipidemia emphasize that ldl-c plays a central role in thepathogenesis of ascvd, and reducing ldl-c levels can significantly decrease therisk of ascvd morbidity and mortality.
source: guidelines for the prevention and treatment of dyslipidemiain chinese adults (2016 revision)