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TextPharmaceutical Guanlan
Today (January 17), the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Roche has submitted a clinical trial application for RO7191863 injection in China, and it has been accepted
.
According to public information, RO7191863 is a liver-directed, PD-L1-targeting N-acetylgalactosamine (GalNac)-modified single-stranded oligonucleotide candidate drug, which is planned to be developed for the treatment of chronic hepatitis
Screenshot source: CDE official website
Hepatitis B is one of the major infectious disease threats in the world
.
Hepatitis B virus (HBV) infection is a major cause of liver disease and is difficult to cure with current treatments
At present, targeting the PD-1/PD-L1 pathway is an emerging approach in the drug development strategy of chronic hepatitis B, but previous studies have mainly explored the therapeutic effect of monoclonal antibodies on the disease
.
According to public information, RO7191863 is a liver-directed N-acetylgalactosamine (GalNac) modified single-stranded oligonucleotide developed by Roche, which can induce RNAseH (ribonuclease H)-mediated PD-L1 mRNA degrade
At the annual meeting of the American Society for the Study of Liver Diseases (AASLD 2021) held in November 2021, Roche announced the results of the Phase 1 clinical study of RO7191863 for the first time
.
According to the abstract, this is the first clinical study of RO7191863 in chronic hepatitis B patients to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of different doses and regimens
According to reports, the subjects enrolled in the study were virologically suppressed chronic hepatitis B patients receiving stable antiviral therapy and no obvious evidence of liver fibrosis, and they participated in the multiple ascending dose (MAD) study
.
A total of 25 patients were enrolled in the trial, who received subcutaneous injections of RO7191863 or placebo in escalating dose levels, dose numbers, and dosing frequency every two weeks (Q2W)
Screenshot source: Reference [2]
Study data showed: RO7191863 appeared in plasma after each dose with a median Tmax of 2.
0 hours followed by a biphasic decline; adverse events (AEs) considered to be related to study treatment occurred in 7 treated patients , the most common were headache and injection site reactions, no serious or immune-related adverse events were observed, and no patients discontinued due to adverse events
.
At the highest dose of 3.
0 mg/kg Q2W, the research and development found that the HBsAg quantification in the six treatment groups decreased by an average maximum of 0.
3 log10 IU/mL from baseline
.
The largest decrease in HBsAg quantification (0.
Screenshot source: Reference [2]
The study concluded that these preliminary safety and efficacy data suggest that targeting the PD-1/PD-L1 pathway through liver-directed inhibition of PD-1/PD-L1 mRNA expression is feasible, and support RO7191863 and other Combination of therapies to achieve functional cure in patients with chronic HBV infection
References:
[1] Center for Drug Evaluation, National Medical Products Administration of China.
