Gilead Sciences Inc. (NASDAQ:GILD) announced positive clinical updates across its portfolio, highlighting key trial data for its twice-yearly HIV prevention injection and its primary biliary cholangitis treatment.
Higher Persistence In PURPOSE 5 HIV Prevention Study
In the Phase 2 PURPOSE 5 study, the biopharmaceutical developer evaluated twice-yearly injectable lenacapavir against daily oral emtricitabine/tenofovir disoproxil fumarate (F/TDF) for pre-exposure prophylaxis (PrEP).
The trial enrolled 267 participants across the U.K. and France who were not taking PrEP at enrollment, including cisgender men, cisgender women, and gender-diverse individuals.
PURPOSE 5 represents the first randomized study specifically designed to compare persistence between a long-acting regimen and daily oral medication in individuals not currently on PrEP.
Week 52 data on Friday demonstrated that 85.6% of lenacapavir recipients maintained strict persistence, compared with 46.3% of participants on daily oral pills.
Zero HIV infections occurred in the lenacapavir cohort over 52 weeks, whereas one individual acquired HIV in the oral group after taking fewer than two doses weekly.
Livdelzi Delivers Sustained Alkaline Phosphatase Reductions
On Thursday, the company released detailed 52-week findings from the Phase 3 IDEAL study evaluating Livdelzi (seladelpar) in primary biliary cholangitis.
By Week 52, 75.4% of participants treated with Livdelzi achieved the alkaline phosphatase (ALP) normalization composite endpoint, compared with 16.1% of patients receiving placebo.
ALP serves as an essential biomarker of disease activity, with higher levels linked to liver failure and poorer long-term clinical outcomes.
Therapeutic benefits began swiftly, as 52.3% of Livdelzi patients met the composite goal after one month versus 6.5% on placebo, with the response sustaining through Week 52.
Safety profiles across both trials proved consistent with previous research. Serious adverse events in the liver study occurred in 3.1% of Livdelzi participants versus 12.9% on placebo, with no events linked to the study drug.
GILD Price Action: Gilead Sciences shares were up 0.46% at $169.11 at the time of publication on Monday, according to Benzinga Pro data.
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