ViiV-sponsored new clinical trials to differentiate its products in portfolio and pipeline

ViiV initiated 3 new clinical trials as listed on Clinical trials public website:

• • Phase 3b 96-week head-to-head trial investigating the efficacy, safety, and tolerability of DTG/3TC (Dovato) vs BIC/F/TAF (Biktarvy) in TN PLWH, NCT05979311). The trial anticipates recruitment of 412 participants for a start date on November 17, 2023, and has a PCD set for August 11, 2025. (8/7)

    • The trial, named VOGUE, will measure Week 48 efficacy as its sole primary endpoint. Some secondary outcomes include PROs (HIVTSQs, symptom distress module), safety, CD4+ cell count changes, renal and metabolic parameters, and BMI.

    • Initiation of this trial may be aimed to seek a label expansion for DTG/3TC into TN populations, while utilizing broad secondary endpoints to probe for points of differentiation 

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  • Phase2b EMBRACE trial investigating the efficacy, safety, PK, and tolerability of CAB + N6LS (VH3810109) was initiated (8/18) and started recruiting (8/28) for an estimated 150 participants with a PCD set for October 23, 2024 (NCT05996471).

    • The trial will evaluate the combination in a suppressed switch population using baseline SoC as comparator. CAB will be administered IM per its currently approved label, while N6LS will be administered both IV and SC, in combination with Halozyme’s rHuPH20.

    • As the most advanced pipeline asset, and the first to be tested in combination with CAB, N6LS is the likely frontrunner for a potential Q3M regimen. In ViiV’s Q2 2023 EC, ViiV suggested this trial could facilitate CAB partner selection in early 2024.

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  • A Phase 1 trial investigating SC and IM administration of the capsid inhibitor VH280 has been initiated in healthy participants (NCT06012136). The trial aims to recruit 160 participants to start on August 22, 2023, with PCD and SCD set for May 1, 2026. (8/25)

    • The trial record suggests that VH280 will be injected as a “single suspension” and will not utilize the Halozyme rHuPH20 technology. While the title states “investigational capsid inhibitors”, only VH280 is included as an experimental agent, suggesting the intend to add its other capsid inhibitor, VH499, to this trial.

    • Oral dosing of capsid inhibitors VH280 (NCT05163522) and VH499 (NCT05393271) has previously been investigated in preliminary Phase 1 trials, with both trials adding an undisclosed “new formulation” arm in 2023.

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  • Phase 1 FTIH study investigating the safety, tolerability and PK of the maturation inhibitor GSK937 in healthy participants reported results (NCT04493684). (8/23)

    • This complements a previous publication (6/2) in which authors concluded that trial results support further investigation of GSK937 as a QW oral, enabled by its longer terminal half-life of ~3 days. However, food increased exposure more than 2-fold compared to the fasted state.

    • By comparison, Ph1 data for ViiV’s discontinued MI GSK3640254 demonstrated a 3-4-fold difference in PK between fed and fasted states. ViiV cited this as one reason for its discontinuation, alongside lack of differentiation in the daily oral market.

    • With preliminary evidence for QW oral potential, it may be an attempt to build a LAO regimen with GSK937 and its ‘third generation’ INSTI, VH184, which has previously been touted for development both as a LAO and LAI.