CLAIM #27056 · GILD (GILD) · 2024Q1 earnings call · Apr 25, 2024 · due Jun 30, 2025
“We expect to complete enrollment in the first half of 2025.”
Merdad Parsey · Chief Medical Officer
In context
“ll continue throughout the rest of the year. Importantly, we anticipate an FDA regulatory decision on seladelpar and 3 Phase III updates across HIV prevention, bladder cancer, and breast cancer. Starting on Slide 17, we continue to progress our industry-leading Virology pipeline, which is building momentum following a data-rich presence at CROI in March. This included robust virologic suppression data from our once-daily oral combination of bictegravir with Lenacapavir from the Phase III portion of the ARTISTRY-1 trial. This novel combination has the potential to benefit people with HIV on complex regimens. We have since started 2 Phase III trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in the first half of 2025. We also have 2 once-weekly oral programs: first, a combination of lenacapavir with Merck’s NRTTI, islatravir, in virologically suppressed people with HIV, expected to advance into Phase III later this year. And second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a Phase III study. This second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTIs are the standard-of-care treatment for HIV, and an important treatment option for clinicians who continue to prefer INSTI-based regimens. Finally, we presented Phase Ib data from our twice-yearly parenteral program of lenacapavir plus our 2 broadly neutralizing antibodies for people with HIV at CROI, and we int”
Verify independently
SEC filings for GILD ↗ · Claim quote is verbatim from the 2024Q1 earnings call.