Precision BioSciences Reports First-Ever Clinical Evidence of cccDNA Elimination in Hepatitis B Trial
DTIL has more than doubled off its 52-week low of $3.53.
Summary
Precision BioSciences reported highly positive clinical data from its ELIMINATE-B trial, showing the first-ever direct elimination of cccDNA in chronic hepatitis B patients, a key step towards a cure.
Key Events · Product Development and Regulatory · DTIL
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First Clinical Evidence of cccDNA Elimination
New biopsy data from the Phase 1 ELIMINATE-B trial demonstrated that PBGENE-HBV directly eliminated cccDNA, leading to a 1-log (10-fold) reduction in cccDNA-derived transcripts. This marks the first clinical evidence of a therapeutic agent achieving cccDNA elimination and inactivation in liver biopsies for chronic hepatitis B.
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100% pgRNA Loss in Patients
New clinical data showed PBGENE-HBV achieved pgRNA loss in 100% of patients (n=6) with detectable pgRNA at baseline. Complete loss of detectable blood pgRNA directly corresponded to undetectable pgRNA in post-treatment liver biopsy, establishing pgRNA as a key biomarker for cccDNA elimination.
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Manageable Safety Profile
The trial demonstrated a clear therapeutic window with a well-characterized and manageable safety profile across multiple dosing cohorts. While transient Grade 3 ALT/AST abnormalities and Grade 3 hypotension were observed, mitigation protocols have been implemented, and no further severe events have occurred since.
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Substantial HBsAg Declines
100% of patients (n=15) experienced substantial HBsAg declines, consistent with PBGENE-HBV's mechanism of cccDNA elimination. The duration of response is ongoing, with some patients showing durable HBsAg decline for over a year.
Analysis · DTIL · Life Sciences
Precision BioSciences announced groundbreaking clinical data from its ELIMINATE-B trial for chronic hepatitis B, demonstrating the first-ever clinical evidence of cccDNA elimination in liver biopsies. This is a critical step towards a functional cure for hepatitis B, a disease with significant unmet medical need. The data shows a 10-fold reduction in cccDNA-derived transcripts and 100% pgRNA loss in treated patients, alongside a manageable safety profile, indicating strong therapeutic potential.
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At the time of this filing, DTIL was trading at $8.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $195.6M. The 52-week trading range was $3.53 to $8.82. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.