WARMINSTER, PA — Arbutus Biopharma Corporation (Nasdaq: ABUS) has released new data from their Phase 2a clinical trial, IM-PROVE I, revealing that imdusiran, their RNAi therapeutic, in combination with a standard-of-care immunomodulator, reduced HBsAg levels in some patients suffering from chronic hepatitis B (cHBV). This successful reduction was observed during and after treatment, with some patients achieving sustained loss of HBsAg.
HBsAg, or Hepatitis B surface antigen, is a protein produced by the virus, and its presence in the blood often signals an active hepatitis B infection. Its reduction, therefore, may indicate a disease control.
The critical findings from this research show that patients who were administered imdusiran and the immunomodulator for 24 to 48 weeks maintained undetectable HBsAg levels. This was sustained 24 weeks after completing the treatment.
In medical terms, to say a virus is “undetectable” means the amount of the virus in the patient’s blood is so low that it doesn’t show up in blood tests. So, the sustained non-detection of HBsAg suggests a high degree of disease control.
Two out of the six patients have successfully maintained undetectable levels of both HBsAg and HBV DNA even 12 weeks after ceasing all treatment. The other four patients are also showing promising progress.
Most excitingly, one patient who received a 12-week treatment has been off all therapy for six months while maintaining undetectable levels of HBsAg and HBV DNA, thereby achieving what is termed a “functional cure”.
The term “functional cure” in the context of diseases like hepatitis B refers to a state where the virus is no longer detectable in the blood, and there are no symptoms or complications, despite the continued presence of the virus in the body.
This groundbreaking trial, although evaluated on small groups of patients, suggests that the combination of imdusiran and immunomodulator could potentially lead to a functional cure for patients who continue to show no signs of the virus post-treatment, a significant breakthrough for the more than 250 million patients chronically infected with HBV worldwide.
Offering further optimism, the same trial shows that the combination treatment was generally safe and well-tolerated, with no serious adverse events related to imdusiran or immunomodulator reported, and no adverse events causing discontinuation.
For Arbutus Biopharma, these results reinforce their belief that reducing surface antigen with imdusiran and integrating an immunomodulator into the treatment regimen could be a potential key to unlocking a functional cure for patients with cHBV.
In light of these promising developments, the scientific and medical community eagerly anticipate the progress of these patients as well as other Phase 2a trials evaluating imdusiran with other immunomodulators. This type of innovation in treatment could herald a new era in the fight against chronic hepatitis B and the quest for a functional cure.
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