Innovent unveils phase 1/2 clinical study results of PCSK9 antibody
Category: #health  By Pankaj Singh  Date: 2020-08-31
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Innovent unveils phase 1/2 clinical study results of PCSK9 antibody

Innovent Biologics, a renowned biopharmaceutical firm that develops, produces, and commercializes innovative medicines to treat metabolic, oncology, autoimmune as well as other prominent diseases, has reportedly announced that results from its Phase 1 and Phase 2  clinical study of fully human recombinant monoclonal antibody, also known as Tafolecimab (IBI306), have been presented successfully at the 2020 ESC (European Society of Cardiology) annual conference.

This makes it the first time where the domestic monoclonal PCSK9 antibody has been recognized by international academics. The announced results were from the CIBI306B101 and CIBI306A101, which showcased satisfactory efficacy safety Tafolecimab profiles.

The rate of incidence for treatment-associated adverse events were effectively comparable between that of the placebo treated group and the Tafolecimab treated group; in the Tafolecimab treated group, reductions in LDL-C were witnessed, which were (-54.30%, -72.26%) and (-52.2%, -72.1%) respectively within hypercholesterolemia patients and healthy participants.

Tafolecimab primarily showcased a longer dosing interval in comparison to marketed PCSK9 inhibitors, which was from 6 weeks or up to 8 weeks as well.

leading CIBI306B101 study PI and Peking University First Hospital, Department of Cardiology director, Prof. Yong Huo stated that Tafolecimab, developed locally is a PCSK9 inhibitor with a good tolerability and safety profile. The candidate can reduce LDL-C levels substantially as per the study results, which might offer more treatment options to hypercholesterolemia patients in China, especially those suffering from non-familial and familial hypercholesterolemia who have high cardiovascular risks.

Yong Huo further added that ESC annual conferences’ acceptance of the clinical study results is a testament to the constant improvement of Chinese clinical research efforts’ innovative capacity.

Innovent CEO and Chairman, Dr. Michael Yu, stated that Tafolecimab is the company’s new innovative drug candidate that was developed independently to treat hypercholesterolemia. ESC’s acceptance of the trial results greatly reflects the clinical application and innovation prospects of Tafolecimab. The company is currently carrying out three pivotal Tafolecimab studies (CREDIT-3, CREDIT-2, CREDIT-1) and looks forward to deliver more personalized as well as convenient options of lipid-lowering to patients and doctors in near future.

Source credit: https://www.prnewswire.com/news-releases/innovent-announces-the-results-of-the-phase-12-clinical-study-of-pcsk9-antibody-tafolecimab-at-the-european-society-of-cardiology-annual-conference-301120711.html



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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