The stock of Arbutus Biopharma Corporation (ABUS) was trading at $2.97 in pre-market trading hours on Wednesday, up 1.37%. Arbutus stock lost -0.68% last session to finish at $2.93. There was a price range of $2.83 to $2.98 for ABUS stock. ABUS traded 1.75 million shares, which was almost equal to its daily average of 1.77 million shares over the past 100 days. ABUS stock is rising following news that it has been given permission to submit an Investigational New Drug application (IND).
What was ABUS IND for?
As a biopharmaceutical company, Arbutus’ primary objective is to discover, develop, and commercialize treatments for chronic Hepatitis B virus (HBV) infections. ABUS believes that multiple product candidates with different mechanisms of action can provide a new treatment regimen for chronic HBV infection, which ABUS is developing. ABUS has also begun to develop drugs to treat coronaviruses including COVID-19.
According to Arbutus press release today, the Food and Drug Administration (FDA) gave its approval for the company to proceed with its Investigational New Drug (IND) application for AB-729 in a Phase 2a clinical trial.
- ABUS will evaluate AB-729 in Phase 2a clinical trial as a proof of concept for CHB patients in conjunction with continuous nucleos(t)ide analog (NA) therapy and short treatments of peg- IFNα -2a.
- As a cornerstone therapy for patients with CHB, the acceptance of AB-729’s IND application is a significant step forward for ABUS.
- As a result, ABUS is now focusing initiating this proof-of-concept Phase 2a clinical trial in current quarter.
- A new IND submission by ABUS is being reviewed and is deemed safe to proceed in patients with chronic hepatitis B virus infection.
- As part of this Phase 2a trial, ABUS is investigating whether short courses of Peg-IFN following HBsAg suppression and immunoreactivation via AB-729 might lead to a functional cure in chronic hepatitis B subjects without HBeAg.
In the Phase 2a Clinical Trial:
Arbutus (ABUS) will conduct this study to investigate the safety and efficacy of AB-729 combined with NA therapy and short courses of Peg- IFNα-2a in subjects suffering from CHB. For the trial, ABUS is expected to enroll 40 noncirrhotic, nonNA-suppressed, HBeAg-negative subjects pending protocol approval.
ABUS will be administering AB-729 to subjects for 24 weeks, during which time they will be randomized into one of four groups. If the treatment stopping criteria are met, all subjects will continue on NA therapy for 24 weeks following completion of Peg- IFNα-2a treatment. ABUS will be intensively following the subjects up for a period of 48 weeks if subjects stop NA therapy.
