Arbutus Biopharma’s on-going clinical trial results have been unveiled at the EASL Congress today, showcasing the safety, tolerability and antiviral efficacy of combining AB-729, their leading RNAi therapeutic, and pegylated interferon alfa-2a (IFN) for patients with chronic hepatitis B virus (cHBV). The preliminary data reveals a generally well-tolerated IFN addition to AB-729 treatment, and suggests the possibility of continued HBsAg declines for certain patients.
The data from the latest trial of AB-729 continues to reinforce Arbutus’s confidence in its ability to effectively suppress HBsAg. The combination of AB-729 and IFN not only appears to be safe, but some patients that received 12 weeks or more of IFN after AB-729 treatment saw encouraging declines in surface antigen as well.
Although this is a small sample size, Arbutus President and Chief Executive Officer, William Collier, is positive the combination treatment may allow the patient’s immune system to control the virus. The company is looking forward to providing more data as patients continue to receive the treatment.
Forty-three patients with cHBV, who had achieved viral suppression and had no detectable HBeAg, took part in a clinical trial on AB-729 (60mg every 8 weeks) and a nucleos(t)ide analog (NA). After 24 weeks of treatment, they were either treated for 12 or 24 further weeks with interferon (IFN) with or without extra doses of AB-729. The preliminary findings of the trial indicated promising results.
AB-729 treatment either on its own or in combination with IFN was generally well tolerated and there were no serious adverse events or discontinuations. It was shown to lead to a mean HBsAg decline of 1.6 log10 at week 24, comparable to the results observed in other clinical trials.
Moreover, 93% of the 41 randomized patients had HBsAg levels below 100 IU/mL during the treatment period. Though 4 patients have reached HBsAg levels below the limit of quantification, none have yet achieved sustained seroclearance. As for IFN-related TEAEs, these were in keeping with the established safety profile; in fact, only 5 patients needed dose modifications due to laboratory abnormalities.
The clinical trial is ongoing with the majority of patients still in the IFN treatment phase monitored for their responses. Following completion of IFN treatment, patients are followed-up for an additional 24 weeks on NA therapy, at the end of which, they are evaluated for NA discontinuation. Thus far, 3 patients have been evaluated to stop NA treatment, with one meeting the pre-defined protocal critera for NA discontinuation.
Arbutus Biopharma has developed a groundbreaking RNAi therapeutic known as AB-729, designed to combat HBV through direct targeting of hepatocytes. Using a novel covalently conjugated N-Acetylgalactosamine delivery technology, the therapy effectively reduces all HBV viral proteins and antigens, the most important of which being HBsAg. So far, clinical trials of AB-729 have been largely successful, presenting overwhelmingly positive results and demonstrating safety and tolerability of single- and multi-doses. AB-729 is now advancing to multiple Phase 2a clinical studies.
Hepatitis B can be a life-threatening condition which, when left untreated, can lead to cirrhosis of the liver and liver cancer. Shockingly, the World Health Organization estimates that over 290 million people globally are infected with this virus and in the United States, it is estimated that 2.4 million individuals are affected by chronic HBV infection. Sadly, an incredible 820,000 people are prematurely taken away by HBV related complications annually, despite the existence of effective treatments and preventive measures in the form of vaccination.
At Arbutus Biopharma Corporation (Nasdaq: ABUS), we are dedicated to leveraging our extensive virology expertise to develop innovative therapeutics that target viral diseases. We currently have multiple clinical-stage therapies focused on Hepatitis B virus, SARS-CoV-2, and other coronaviruses. Our flagship product, AB-729, is a unique RNAi-based therapeutic that has the potential to provide a functional cure for patients with chronic HBV by suppressing viral replication and boosting the immune system.
We are continuing to discover and develop more treatments for coronaviruses, and we are also researching possible applications within the oncology field. By pushing the boundaries of scientific innovation, Arbutus is striving to bring more effective treatments and potential cures to those who need them.
Forward-Looking Statements and Information
At GlycoMimetics, Inc., we are thrilled to announce our plans to further develop our product candidates and advance our clinical development plans. Our clinical trials and other studies are expected to cost, produce results and have a timeline outlined for their completion. With the help of our third-party collaborations, we anticipate our product candidates to have a high probability of success in clinical trials. We look forward to the release of data from our clinical trials and the potential of our product candidates to achieve success.
Arbutus is firmly optimistic about the progress of its preclinical studies and clinical trials as well as the timely receipt of regulatory approvals, despite the economic and market uncertainties presented by the ongoing COVID-19 pandemic and patent litigation matters. We are confident that our assets will remain in demand and that economic and market conditions will remain stable, enabling us to see our plans and ambitions come to fruition.
Arbutus faces numerous risks that may impede or prevent its future success. These risks include the possibility of pre-clinical studies and clinical trials costing more or taking longer than expected, not receiving necessary regulatory approvals for product candidate clinical development, and the ongoing COVID-19 pandemic disrupting Arbutus’ clinical development programs.
Additionally, uncertain litigation cases and market shifts could require a change in focus, which could lead to a loss of expected benefits of any collaborations. Even with all these risks, Arbutus remains steadfast in its mission to develop new treatments to address unmet medical needs.
Arbutus faces a multitude of risks and uncertainties that can affect its operations and progress. A full discussion of these risks and uncertainties can be found in Arbutus’ annual Form 10-K, quarterly reports on Form 10-Q, and other continuous and periodic disclosure filings.