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▎WuXi AppTec Content Team Editor Today, GSK announced that its investigational chronic hepatitis B therapy, bepirovirsen, jointly developed with Ionis, has achieved positive results
in a Phase 2b clinical trial 。 This antisense oligonucleotide (ASO) therapy is used as a single agent or in combination with nucleoside/nucleotide analogues (NA) to permanently clear hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA
in patients with chronic hepatitis B.
About 10% of patients still have no HBsAg and HBV DNA
detectable 24 weeks after stopping treatment.
According to the press release, these results provide an early signal
that bepirovirsen can achieve a functional cure as monotherapy or in combination with NA.
Hepatitis B is a liver disease caused by hepatitis B virus infection that affects the lives of
nearly 300 million people worldwide.
Current therapies are difficult to completely cure hepatitis B, and chronic hepatitis B may further worsen and develop into diseases
such as cirrhosis and liver cancer.
At present, "functional cure" is a major focus
of hepatitis B treatment.
This means that although we cannot completely clear the virus out of the body, with treatment, it can be limited to very low levels, so low that it cannot be detected in the blood
.
The researchers also hope that at such low levels, hepatitis B patients can rely on their own immunity to control the disease without continuing to receive drugs
.
Bepirovirsen, which brings promising results, is an antisense oligonucleotide therapy that recruits enzymes in liver cells to destroy RNA from the virus by precisely matching the RNA of hepatitis B virus, thereby halting the replication of hepatitis B virus and the production
of viral proteins.
In addition, the drug further stimulates the body's immune system to help it destroy the hepatitis B virus
in the blood.
In other words, bepirovirsen can do both, on the one hand, to inhibit the replication of hepatitis B virus, on the other hand, to promote the attack of the immune system against hepatitis B virus, and reduce chronic infection of hepatitis B
.
The therapy was originally discovered by Ionis Pharmaceuticals and transferred to co-development
by GSK and Ionis in 2019 through an agreement.
In this Phase 2b clinical trial, a total of 457 patients with chronic hepatitis B were treated with different doses of bepirovirsen, about half of whom were also receiving NA and the other half were not
.
Previously released interim results showed that after 24 weeks of treatment with 300 mg bepirovirsen, about 26~29% of patients had hepatitis B surface antigen and hepatitis B virus DNA levels below the lowest detectable level (Lower Limit of Quantification
).
The goal of functional cure is that after discontinuation of the drug, the patient's immune system is able to successfully control the replication of the virus and the production
of viral proteins.
Therefore, the patients in this study were discontinued after 24 weeks of treatment and subsequently underwent 24 weeks of follow-up observation
.
The test results showed that after 24 weeks of discontinuation of the drug, 9~10% of patients who had received 300 mg of bepirovirsen for 24 weeks still maintained undetectable levels of hepatitis B surface antigen and hepatitis B virus DNA
.
The detailed results of this study have been published in the prestigious medical journal New England Journal of Medicine
.
▲Further analysis of the trial results of patients in this phase 2b clinical trial after 24 weeks of discontinuation (image source: reference [3])
found that Of these patients who maintained undetectable levels of HBAG and HBV DNA after 24 weeks of withdrawal, half were able to produce antibodies to the hepatitis B protein, indicating that the patient's immune system was activated
.
Professor Man-Fung Yuen of the University of Hong Kong, lead investigator of the clinical study, said: "Chronic hepatitis B is very difficult to treat
.
Data from this study provide an opportunity
for a potential functional cure for millions of chronic hepatitis B patients worldwide.
"
GSK will continue to follow up patients while exploring whether initiation of long-acting interferon therapy after the end of bepirovirsen treatment can prolong functional cure
.
" Meanwhile, Bepirovirsen's Phase 3 clinical trial will begin
in the first half of next year.
In recent years, a variety of new models for the treatment of hepatitis B have been progressing in clinical trials, and recently, Vir Biotechnology's RNAi therapy in combination with long-acting interferon has shown significant long-term efficacy
in inhibiting hepatitis B surface antigen.
The company's combination of neutralizing antibodies and RNAi therapeutics has also shown positive results
in clinical trials.
It is expected that these innovative treatment models will eventually achieve the goal of maintaining long-lasting efficacy without lifelong treatment, and change the paradigm of hepatitis B treatment
.
▲To learn more about the application of cutting-edge technologies in the biomedical industry, please press and hold to scan the QR code above to visit the "WuXi Live Room" to watch live discussions and highlights
of related topics
References: [1] Positive data for bepirovirsen from B-Clear phase IIb trial presented at American Association for the Study of Liver Diseases’ Meeting with simultaneous publication in the New England Journal of Medicine.
Retrieved November 8, 2022, from style="font-size: 10px;color: rgb(178, 178, 178);" _mstmutation="1" _istranslated="1"> [2] GSK presents promising new data for bepirovirsen, an investigational treatment for chronic hepatitis B.
Retrieved November 8, 2022, from style="font-size: 10px;color: rgb(178, 178, 178);" _mstmutation="1" _istranslated="1"> [3] Yuen et al.
, (2022).
Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection.
NEJM, DOI: 10.
1056/NEJMoa2210027 Disclaimer: WuXi AppTec's content team focuses on global biomedical health research progress
.
This article is for informational purposes only, and the views expressed in this article do not represent the position of WuXi AppTec, nor do they represent WuXi AppTec's support or disapproval of the views
expressed herein.
This article is also not a treatment recommendation
.
For guidance on treatment options, go to a regular hospital
.
in a Phase 2b clinical trial 。 This antisense oligonucleotide (ASO) therapy is used as a single agent or in combination with nucleoside/nucleotide analogues (NA) to permanently clear hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA
in patients with chronic hepatitis B.
About 10% of patients still have no HBsAg and HBV DNA
detectable 24 weeks after stopping treatment.
According to the press release, these results provide an early signal
that bepirovirsen can achieve a functional cure as monotherapy or in combination with NA.
Hepatitis B is a liver disease caused by hepatitis B virus infection that affects the lives of
nearly 300 million people worldwide.
Current therapies are difficult to completely cure hepatitis B, and chronic hepatitis B may further worsen and develop into diseases
such as cirrhosis and liver cancer.
At present, "functional cure" is a major focus
of hepatitis B treatment.
This means that although we cannot completely clear the virus out of the body, with treatment, it can be limited to very low levels, so low that it cannot be detected in the blood
.
The researchers also hope that at such low levels, hepatitis B patients can rely on their own immunity to control the disease without continuing to receive drugs
.
Bepirovirsen, which brings promising results, is an antisense oligonucleotide therapy that recruits enzymes in liver cells to destroy RNA from the virus by precisely matching the RNA of hepatitis B virus, thereby halting the replication of hepatitis B virus and the production
of viral proteins.
In addition, the drug further stimulates the body's immune system to help it destroy the hepatitis B virus
in the blood.
In other words, bepirovirsen can do both, on the one hand, to inhibit the replication of hepatitis B virus, on the other hand, to promote the attack of the immune system against hepatitis B virus, and reduce chronic infection of hepatitis B
.
The therapy was originally discovered by Ionis Pharmaceuticals and transferred to co-development
by GSK and Ionis in 2019 through an agreement.
In this Phase 2b clinical trial, a total of 457 patients with chronic hepatitis B were treated with different doses of bepirovirsen, about half of whom were also receiving NA and the other half were not
.
Previously released interim results showed that after 24 weeks of treatment with 300 mg bepirovirsen, about 26~29% of patients had hepatitis B surface antigen and hepatitis B virus DNA levels below the lowest detectable level (Lower Limit of Quantification
).
The goal of functional cure is that after discontinuation of the drug, the patient's immune system is able to successfully control the replication of the virus and the production
of viral proteins.
Therefore, the patients in this study were discontinued after 24 weeks of treatment and subsequently underwent 24 weeks of follow-up observation
.
The test results showed that after 24 weeks of discontinuation of the drug, 9~10% of patients who had received 300 mg of bepirovirsen for 24 weeks still maintained undetectable levels of hepatitis B surface antigen and hepatitis B virus DNA
.
The detailed results of this study have been published in the prestigious medical journal New England Journal of Medicine
.
▲Further analysis of the trial results of patients in this phase 2b clinical trial after 24 weeks of discontinuation (image source: reference [3])
found that Of these patients who maintained undetectable levels of HBAG and HBV DNA after 24 weeks of withdrawal, half were able to produce antibodies to the hepatitis B protein, indicating that the patient's immune system was activated
.
Professor Man-Fung Yuen of the University of Hong Kong, lead investigator of the clinical study, said: "Chronic hepatitis B is very difficult to treat
.
Data from this study provide an opportunity
for a potential functional cure for millions of chronic hepatitis B patients worldwide.
"
GSK will continue to follow up patients while exploring whether initiation of long-acting interferon therapy after the end of bepirovirsen treatment can prolong functional cure
.
" Meanwhile, Bepirovirsen's Phase 3 clinical trial will begin
in the first half of next year.
In recent years, a variety of new models for the treatment of hepatitis B have been progressing in clinical trials, and recently, Vir Biotechnology's RNAi therapy in combination with long-acting interferon has shown significant long-term efficacy
in inhibiting hepatitis B surface antigen.
The company's combination of neutralizing antibodies and RNAi therapeutics has also shown positive results
in clinical trials.
It is expected that these innovative treatment models will eventually achieve the goal of maintaining long-lasting efficacy without lifelong treatment, and change the paradigm of hepatitis B treatment
.
▲To learn more about the application of cutting-edge technologies in the biomedical industry, please press and hold to scan the QR code above to visit the "WuXi Live Room" to watch live discussions and highlights
of related topics
References: [1] Positive data for bepirovirsen from B-Clear phase IIb trial presented at American Association for the Study of Liver Diseases’ Meeting with simultaneous publication in the New England Journal of Medicine.
Retrieved November 8, 2022, from style="font-size: 10px;color: rgb(178, 178, 178);" _mstmutation="1" _istranslated="1"> [2] GSK presents promising new data for bepirovirsen, an investigational treatment for chronic hepatitis B.
Retrieved November 8, 2022, from style="font-size: 10px;color: rgb(178, 178, 178);" _mstmutation="1" _istranslated="1"> [3] Yuen et al.
, (2022).
Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection.
NEJM, DOI: 10.
1056/NEJMoa2210027 Disclaimer: WuXi AppTec's content team focuses on global biomedical health research progress
.
This article is for informational purposes only, and the views expressed in this article do not represent the position of WuXi AppTec, nor do they represent WuXi AppTec's support or disapproval of the views
expressed herein.
This article is also not a treatment recommendation
.
For guidance on treatment options, go to a regular hospital
.
