GSK plc has announced positive results coming from its two pivotal phase III trials – the B-Well 1 and B-Well 2 phase III trials, assessing bepirovirsen, which is an investigational antisense oligonucleotide – ASO used for the treatment of chronic hepatitis B – CHB across 1,800 patients from 29 countries.
It is well to be noted that CHB is a major health issue that affects more than 250 million people across world and, as a matter of fact, is one of the leading causes of liver cancer. The present standard of care which is nucleos(t)ide analogues often needs a lifelong therapy and also the functional cure rates go on to remain low, usually just 1%. A functional cure when it comes to CHB is when the virus can no longer be detected within the blood, as measured by sustained loss of hepatitis B surface antigen, which is a viral protein signaling the ongoing infection, and undetectable hepatitis B virus DNA for a minimum of 24 weeks post a finite course of treatment. This enables the immune system to go ahead and control the infection without any more medication. Functional cure gets associated with major reduction within the risk of long-term liver complications, which includes liver cancer, along with all-cause mortality.
Notably, the B-Well trials went on to meet their primary endpoint, and also bepirovirsen went ahead and showcased a statistically prominent and clinically meaningful functional cure rate. Functional cure rates happened to be significantly higher due to bepirovirsen plus standard of care compared to standard of care alone. Apparently, the outcomes were statistically prominent throughout all ranked endpoints, such as patients with baseline surface antigen – HBsAg<=1000 IU/ml where even greater effect was showcased. The trials went on to demonstrate an acceptable safety along with a tolerability profile that was consistent with what was reported across other studies.
The chief scientific officer of GSK, Tony Wood, said that Bepirovirsen indeed has the potential to transform the treatment targets for people who are living with CHB through attaining quite major functional cure rates, which is indeed a first for the disease.
Notably, CHB goes on to affect over 250 million people and also leads to around 56% of liver cancer cases across the world. The results that have come out support their plans to progress bepirovirsen as a treatment and also continue with its development as a backbone in future sequential therapies. He added that they are pleased due to this major advance in their expanding hepatology pipeline which is aimed to transform the outcomes when it comes to liver disease.
It is well to be noted that full results are going to be submitted for presentation in an upcoming scientific congress that’s published in a peer-reviewed journal and also used to support regulatory submissions to health authorities across the world. If approved, bepirovirsen indeed has the potential to go ahead and become the first finite, six-month therapeutic choice for CHB and to serve as a backbone for the future sequential treatment strategies.
B-Well 1 and B-Well 2 phase III trials, is an international, multicenter, randomized, double-blind, and placebo-controlled trial that has been conducted throughout 29 countries. They showcased the safety, efficacy, and pharmacokinetic profile as well as the durability of functional cure within nucleotide analogue – NA-treated participants having CHB and baseline surface antigen – HBsAg =3000 IU/ml. The primary endpoint evaluated the proportion of participants attaining functional cure within patients having baseline surface antigen – HBsAg =3000 IU/ml. A key ranked secondary endpoint assessed the functional cure within participants having baseline HBsAg =1000 IU/ml. Functional cure apparently is defined as hepatitis B surface antigen – HBsAg loss and also undetectable HBV DNA for a minimum of 24 weeks post a finite course of treatment.
Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic hepatitis B takes place when the immune system is not able to clear the virus, thereby resulting in a long-lasting infection that goes on to affect over 250 million people across the world. The disease goes on to cause around 1.1 million deaths every year and comprises almost 56% of liver cancer cases across the world. Many patients often go on to require lifelong antiviral therapy for viral suppression, thereby making the functional cure a major goal in the disease management.
Bepirovirsen is defined as a triple-action investigational antisense oligonucleotide – ASO designed in order to recognize and also orchestrate the destruction of the genetic components. i.e., RNA of the hepatitis B virus, which can lead to chronic disease, potentially leading to a person’s immune system regaining control. Bepirovirsen inhibits replication of viral DNA within the body and suppresses the hepatitis B surface antigen – HBsAg level in the blood and also, in a way, stimulates the immune system to increase the chances of durability along with a sustained response.
Interestingly, GSK licensed bepirovirsen from Ionis and partnered with them on the development. Bepirovirsen has been regarded by global regulatory authorities due to its innovation and potential to go ahead and address a major unmet need in hepatitis B, with a Fast Track designation from the US FDA, a Breakthrough Therapy designation in China, and also a SENKU designation in Japan.
GSK for long has been a global biopharma company with a purpose to unite science and technology along with talent to go past the disease together.
