CLAIM #27103 · GILD (GILD) · 2024Q2 earnings call · Aug 8, 2024 · due Dec 31, 2025
“This regimen is expected to be the first once-weekly oral treatment option.”
Merdad Parsey · Chief Medical Officer
In context
“eting included: Longer-term Phase 2 data from our once-daily oral combination of bictegravir and lenacapavir that showed the regimen was highly effective at maintaining viral suppression. These results further support our ongoing Phase 3 studies in people with HIV, including those on complex regimens. We also reported safety and PK data for both GS-4182, an oral pro-drug of lenacapavir designed to provide 2- to 3-times greater oral bioavailability, and GS-1720, our long-acting oral integrase inhibitor. Initiation of the Phase 2 trial evaluating the combination of these agents as a once-weekly oral regimen is expected later this year. Additionally, we are on-track to initiate our Phase 3 ISLEND-1 and ISLEND-2 trials evaluating once-weekly lenacapavir in combination with Merck's islatravir. This regimen is expected to be the first once-weekly oral treatment option. Looking at our longer-duration treatments, we expect to provide Phase 1 updates from our every 3- month injectable programs and to initiate the Phase 1 studies for our potentially every 6-month integrase inhibitors in the second half of the year. Moving to our Liver Disease portfolio, on slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the EASL Conference in June, highlighting our continued leadership. Importantly, as shown on the right of the slide, new interim results from the open-label Phase 3 ASSURE study of seladelpar for PBC were consistent with the pivotal RESPONSE study that formed the basis of our global regulatory filings. As you know, we expect an FDA regulatory decision shortly, with a decision from European regulators to foll”
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SEC filings for GILD ↗ · Claim quote is verbatim from the 2024Q2 earnings call.