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Precision BioSciences Announces Initial Safety and Antiviral Activity of PBGENE-HBV in the ELIMINATE-B Clinical Trial
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Hepatology Communications 2023 April
Wen-Juei Jeng, Anna S. Lok
Download the PF here
February 19, 2025
•ELIMINATE-B Phase 1 dose finding study for chronic Hepatitis B executing on schedule with completion of first dose administration for cohort 1 (n=3 patients)
•PBGENE-HBV, the first LNP gene editing technology studied for Hepatitis B, was safe and well tolerated
•PBGENE-HBV demonstrated substantial antiviral activity measured by reduction of Hepatitis B surface antigen (HBsAg) after one administration at the lowest dose level
•First clinical proof-of-concept in chronic Hepatitis B for a unique editing modality designed to directly eliminate and inactivate the root cause of Hepatitis B virus from covalently closed circular DNA (cccDNA) and integrated DNA
•These PBGENE-HBV data mark the second clinical validation for ARCUS in vivo gene editing in 2025
DURHAM, N.C.--(BUSINESS WIRE)--Feb. 19, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced initial results from the first administration of PBGENE-HBV in cohort 1, the lowest dose level of the ELIMINATE-B trial. The ELIMINATE-B trial is designed to investigate PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients afflicted with chronic Hepatitis B who are HBeAg-negative.
PBGENE-HBV, which comprises an ARCUS-encoding mRNA encapsulated in a lipid nanoparticle (LNP), was safe and well tolerated in all three participants in cohort 1 after the first administration of a 0.2 mg/kg dose. The planned dosing schedule in ELIMINATE-B allows for two additional administrations at this dose level while in parallel investigating the next higher dose level. The participants treated in cohort 1 possessed different baseline characteristics: age of infection, duration of infection and level of HBsAg. Across the three participants dosed, none experienced a Grade ≥2 treatment-related adverse event or serious adverse event.
In addition to safety, PBGENE-HBV demonstrated a substantial reduction in Hepatitis B surface antigen (HBsAg) in two of the three participants following the first administration at dose level 1.
The ELIMINATE-B study is currently enrolling HBeAg-negative chronic Hepatitis B patients at world-class sites in Moldova, Hong Kong, and New Zealand. Investigators accrued the first cohort of patients within a month. The company is on schedule to provide additional administrations at this dose level and subsequently plans to escalate to higher dose levels to define the optimal dose and number of dose administrations for safely eliminating cccDNA and inactivating integrated HBV DNA. Precision expects to expand the study to the U.S.and U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1 study. Precision plans to share detailed clinical data throughout 2025.
"Prior to commencing the ELIMINATE-B clinical trial, we conducted numerous preclinical studies with PBGENE-HBV to understand the pharmacokinetics, safety, and impact on viral markers at various dose levels and following multiple dose administrations. Importantly, the early data in the first cohort of patients is consistent with the safety and HBsAg reductions observed in our preclinical models," said Cassie Gorsuch, PhD, Chief Scientific Officer. "The safety and early reduction of HBsAg suggests that PBGENE-HBV is doing what no previous treatment has been able to accomplish, eliminating the source of viral replication in cccDNA and inactivating integrated disease."
Full pdf press release attached.
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