At this year’s EASL International Liver Congress, Vir took center stage Wednesday to report early Phase 2 data for its hepatitis D approach, and then saw its stock $VIR jump as much as 15% upon data release.
And there were other biotechs with hepatitis data in Milan, with Aligos Therapeutics, Arbutus Biopharma and Barinthus Biotherapeutics reporting their respective hepatitis B data. Atea Pharmaceuticals was also there to present results in hepatitis C, and Bluejay Therapeutics shared data for its hepatitis D candidate. Here’s a roundup of what you need to know.
Aligos’ new focus
Aligos reprioritized its pipeline last year, cutting 10% of its staff and elevating its hepatitis B programs.
On Wednesday, the company said that its hepatitis B candidate ALG-000184 can deliver sustained HBV DNA suppression in nine out of 10 HBeAg-positive patients, without viral breakthrough. HBV DNA is a marker for the amount of detectable virus in the body, and HBeAg refers to hepatitis B e-antigen.
Meanwhile, in patients who are HBeAg-negative, all 11 participants experienced complete suppression of HBV DNA and RNA. HBeAg is a protein made by an actively-reproducing virus that circulates in infected blood. — Katherine Lewin
Arbutus’ triple regimen data
Arbutus’ Phase 2a program has a triple approach that features its RNAi candidate, named imdusiran, taken for either 24 or 48 weeks, plus standard-of-care interferon for 24 weeks and ongoing nucleos(t)ide analogue (NA) therapy. At the confab, the company said this regimen can reduce viral surface antigen levels (HBsAg).
In the trial, one-third of patients who received the triple approach had undetectable HBsAg levels at the end of treatment. And in these patients, who completed imdusiran for 48 weeks and interferon for 24 weeks but kept taking NA therapy, the results were maintained 24 weeks later.
Analysts at Chardan were encouraged by the data, adding in a note that imdusiran “is a partnerable asset.” — Katherine Lewin
Atea to recruit more patients
Atea is gunning for hepatitis C with its combo treatment of bemnifosbuvir, an oral nucleotide NS5B polymerase inhibitor, and ruzasvir, an oral NS5A inhibitor, with early Phase 2 data.
After the eight-week treatment course, 97% of patients had a sustained virologic response rate 12 weeks post-therapy. The new analysis covers 60 patients recruited in the lead-in cohort.
The Phase 2 study isn’t over yet. It will continue, this time adding another 220 patients. — Katherine Lewin
Barinthus touts potential
An interim analysis of Barinthus’ lead chronic hepatitis B treatment combo suggested that it boosted patients’ ability to stomp out viral replication.
Out of 91 enrolled patients, 21 had passed the 169-day mark post-treatment with VTP-300 and a low dose of Bristol Myers Squibb’s Opdivo. Barinthus found that 76% of screened patients were eligible for nucleos(t)ide analogue discontinuation, though only seven did. Five out of the seven patients remained off the common viral suppressing regimen as of the April 15 data cutoff.
The company reported that four out of 21 (19%) patients screened for discontinuation had no detectable levels of the hepatitis B surface antigen, and 14 patients had surface antigen levels below <10 IU/mL. — Max Bayer
Bluejay backs up new financing
A month after securing $182 million in new Series C cash, Bluejay said the lowest dose of its lead antibody treatment against chronic hepatitis D spurred notable antiviral activity in all 10 patients treated.
An interim look at the trial found that all 10 patients given 300 mg of BJT-778 once weekly achieved a “virologic response” by week 28, defined as either a 2 log reduction in HDV RNA or RNA levels becoming undetectable.
So far, the 300 mg dose has performed slightly better than the 600 mg option, the latter of which is administered once weekly for 12 weeks and then once every two weeks for 36 weeks. In the larger dose arm, eight out of 10 patients notched a virologic response.
Bluejay did not report efficacy data from the largest 900 mg dose arm, as patient data were limited to less than four weeks as of the data cutoff. The biotech said that no serious or grade 3/4 adverse events had been reported to date across the three study arms, and no patients had discontinued due to side effects. — Max Bayer