WARMINSTER, Pa. and OXFORD, United Kingdom (TADAWUL:4280) - Arbutus Biopharma (NASDAQ:ABUS) Corporation (NASDAQ:ABUS) and Barinthus Biotherapeutics plc (NASDAQ:BRNS) have shared preliminary data from the Phase 2a IM-PROVE II clinical trial indicating that a combination of imdusiran, VTP-300, and low-dose nivolumab may lead to significant declines in hepatitis B surface antigen (HBsAg) levels in people with chronic hepatitis B virus (cHBV).
The trial, which included non-cirrhotic virally suppressed cHBV participants, showed that 23% of participants receiving the combination achieved HBsAg loss by Week 48. This loss is a potential indicator of the treatment's effectiveness. The results were presented at the American Association for the Study of Liver Diseases (AASLD) "The Liver Meeting® 2024."
Imdusiran, an RNAi therapeutic developed by Arbutus, was used in a lead-in treatment that resulted in mean declines in HBsAg levels. When combined with Barinthus Bio's T-cell stimulating immunotherapeutic VTP-300 and the anti-PD-1 monoclonal antibody nivolumab, participants experienced even greater declines in HBsAg levels at Week 48 compared to other groups in the trial who did not receive nivolumab.
The treatment regimen was well tolerated and did not result in any immune-related adverse events, suggesting a favorable safety profile. Dr. Leon Hooftman, Chief Medical (TASE:PMCN) Officer of Barinthus Bio, and Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma, expressed optimism about the regimen's potential based on the preliminary data.
Imdusiran is designed to reduce all HBV viral proteins and antigens, while VTP-300 is the first antigen-specific immunotherapy shown to induce sustained reductions in HBsAg. The combination of these treatments with low-dose nivolumab is aimed at reawakening the HBV-specific immune response.
The IM-PROVE II trial initially enrolled 40 participants and was later expanded to include an additional 22 participants in Group C, which is the focus of the recent data release.
These findings are based on a press release statement from Arbutus Biopharma Corporation and Barinthus Biotherapeutics plc. Further research and analysis will be necessary to confirm the long-term efficacy and safety of the treatment regimen.
In other recent news, Arbutus Biopharma Corporation reported its third quarter 2024 results, providing a corporate update and sharing progress on its clinical programs for Hepatitis B (HBV). The update was led by Interim President and CEO Mike McElhaugh and Chief Financial Officer David Hastings. However, specific financial performance metrics or outcomes were not detailed in the provided summary. The company highlighted the active development in its pipeline, indicating progress in its ongoing clinical programs for HBV. Arbutus Biopharma cautioned that forward-looking statements are subject to risks and uncertainties, which could impact future results. The call concluded with a Q&A session, offering an opportunity for direct engagement with the company's leadership. These are part of the recent developments surrounding the company.
InvestingPro Insights
The promising preliminary data from Arbutus Biopharma's (NASDAQ:ABUS) Phase 2a clinical trial aligns with some of the company's recent financial metrics and analyst sentiments. According to InvestingPro data, Arbutus has seen a strong return over the last year, with a 97.28% price total return. This performance may reflect investor optimism about the company's pipeline, including imdusiran.
Despite the positive clinical results, it's important to note that Arbutus is not currently profitable, with a negative P/E ratio of -9.02 for the last twelve months as of Q3 2024. This is consistent with the company's focus on research and development in the biotechnology sector, where profitability often follows successful drug development and commercialization.
InvestingPro Tips highlight that Arbutus holds more cash than debt on its balance sheet, which is crucial for biotech companies as it provides financial flexibility to fund ongoing clinical trials and potential commercialization efforts. Additionally, the company's liquid assets exceed short-term obligations, indicating a solid financial position to support its research initiatives.
Investors should be aware that Arbutus's stock price movements are quite volatile, which is typical for biotech companies with key products in development. The company is trading at a high revenue valuation multiple, suggesting that market expectations for future growth are significant.
For those interested in a deeper analysis, InvestingPro offers 13 additional tips for Arbutus Biopharma, providing a more comprehensive view of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.