Precision BioSciences Touts Encouraging Initial Safety And Antiviral Activity Of Hepatitis B Treatment Candidate

Zinger Key Points

PBGENE-HBV was safe and well tolerated at 0.2 mg/kg, with no serious adverse events in cohort 1 of the ELIMINATE-B trial.
Two of three participants showed a substantial reduction in HBsAg after the first dose, supporting early antiviral activity.
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On Wednesday, Precision BioSciences, Inc. DTIL revealed 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 chronic Hepatitis B patients who are HBeAg-negative.

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PBGENE-HBV, which comprises an ARCUS-encoding mRNA encapsulated in a lipid nanoparticle (LNP), was safe and well tolerated in all three cohort 1 participants 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 simultaneously investigating the next higher dose level.

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.

With a well-tolerated safety profile and early antiviral activity established at pre-specified time points, Precision will complete subsequent administrations in all cohort 1 patients.

The ELIMINATE-B study is currently enrolling HBeAg-negative chronic Hepatitis B patients at sites in Moldova, Hong Kong, and New Zealand.

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 covalently closed circular DNA (cccDNA) and inactivating integrated HBV DNA.

Precision plans to share detailed clinical data throughout 2025. HC Wainwright analyst Patrick Trucchio reiterates Precision BioSciences with a Buy and maintains a $60 price target.

Price Action: DTIL stock is up 9.22% at $5.63 at last check Wednesday.

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