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▎WuXi AppTec Content Team Editor A few days ago, VBI Vaccines announced that the second phase 2a/2b clinical trial of VBI-2601 (BRII-179), a novel recombinant protein immunotherapy jointly developed with Brii Biosciences, has been completed.
Completion of first patient dosing
.
This trial was designed to evaluate the safety and efficacy of VBI-2601 as an add-on therapy to standard therapy for hepatitis B in non-cirrhotic patients with hepatitis B virus infection
.
Hepatitis B is one of the most significant infectious disease threats in the world, with more than 290 million people infected globally
.
Hepatitis B virus infection is a major cause of liver disease, and current treatments are difficult to cure, and many patients develop liver cancer
.
Every year, about 780,000 people die from complications of chronic hepatitis B virus, such as liver decompensation and hepatocellular carcinoma
.
VBI-2601 is an innovative recombinant protein-based immunotherapy designed to enhance B- and T-cell immune responses based on a VBI-based prophylactic HBV vaccine candidate
.
The vaccine has been approved by the US FDA under the English trade name PreHevbrio
.
Image source: 123RF Phase 2a of this randomized, double-blind, placebo-controlled Phase 2a/2b clinical trial is expected to enroll 120 patients, with the primary endpoint being the percentage of patients with HBsAg clearance at treatment completion; 480 patients will be re-enrolled in Phase 2b The primary endpoint was the percentage of patients achieving functional cure (defined as undetectable HBsAg and observed sustained suppression of HBV DNA)
.
Mr.
Jeff Baxter, President and Chief Executive Officer of VBI, said: "Our commitment to combating hepatitis B includes both prevention and treatment of the disease
.
This work includes evaluating new treatment options, as well as ways to potentially improve current standard of care to achieve a functional cure.
, and thus a multi-pronged approach to advancing chronic hepatitis B virus treatment
.
We look forward to sharing data from these two Phase 2 trials in the second half of 2022 and the first half of 2023.
”
Reference: [1] VBI Vaccines Announces Dosing of First Patient in Second Phase 2 Study in Chronic Hepatitis B Patients as Part of Expansion of Clinical Collaboration With Brii Bio.
Retrieved January 5, 2021, from https:// of-first-patient-in-second-phase-2-study-in-chronic-hepatitis-b-patients-as-part-of-expansion-of-clinical-collaboration-with-brii-bio/Disclaimer: Medicine The content team of Mingkant focuses on introducing the progress of global biomedical health research
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
Completion of first patient dosing
.
This trial was designed to evaluate the safety and efficacy of VBI-2601 as an add-on therapy to standard therapy for hepatitis B in non-cirrhotic patients with hepatitis B virus infection
.
Hepatitis B is one of the most significant infectious disease threats in the world, with more than 290 million people infected globally
.
Hepatitis B virus infection is a major cause of liver disease, and current treatments are difficult to cure, and many patients develop liver cancer
.
Every year, about 780,000 people die from complications of chronic hepatitis B virus, such as liver decompensation and hepatocellular carcinoma
.
VBI-2601 is an innovative recombinant protein-based immunotherapy designed to enhance B- and T-cell immune responses based on a VBI-based prophylactic HBV vaccine candidate
.
The vaccine has been approved by the US FDA under the English trade name PreHevbrio
.
Image source: 123RF Phase 2a of this randomized, double-blind, placebo-controlled Phase 2a/2b clinical trial is expected to enroll 120 patients, with the primary endpoint being the percentage of patients with HBsAg clearance at treatment completion; 480 patients will be re-enrolled in Phase 2b The primary endpoint was the percentage of patients achieving functional cure (defined as undetectable HBsAg and observed sustained suppression of HBV DNA)
.
Mr.
Jeff Baxter, President and Chief Executive Officer of VBI, said: "Our commitment to combating hepatitis B includes both prevention and treatment of the disease
.
This work includes evaluating new treatment options, as well as ways to potentially improve current standard of care to achieve a functional cure.
, and thus a multi-pronged approach to advancing chronic hepatitis B virus treatment
.
We look forward to sharing data from these two Phase 2 trials in the second half of 2022 and the first half of 2023.
”
Reference: [1] VBI Vaccines Announces Dosing of First Patient in Second Phase 2 Study in Chronic Hepatitis B Patients as Part of Expansion of Clinical Collaboration With Brii Bio.
Retrieved January 5, 2021, from https:// of-first-patient-in-second-phase-2-study-in-chronic-hepatitis-b-patients-as-part-of-expansion-of-clinical-collaboration-with-brii-bio/Disclaimer: Medicine The content team of Mingkant focuses on introducing the progress of global biomedical health research
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.