Clinical Daily Summary: What Happened on November 10, 2026

Pelacarsen lowered Lp(a), without reducing cardiovascular events

In the Phase III HORIZON study, pelacarsen lowered Lp(a) by an average of nearly 80% after 12 months of treatment.1 The reduction did not improve cardiovascular outcomes across multiple endpoints or subgroup analyses.1

Vir’s hepatitis D combination met its Phase III primary endpoint

Vir Biotechnology said its combination of elebsiran and tobevibart met the primary endpoint in ECLIPSE 1, a Phase III trial in chronic hepatitis delta.2 At week 48, 44% of participants receiving monthly injections had undetectable virus and normalized ALT. None in the delayed-treatment group had both outcomes at week 12.2 The combination also met a key secondary endpoint. At week 48, 79% of treated participants had undetectable viral levels, compared with none in the comparator arm.2 One treatment-related Grade 3 event, a temporary decrease in neutrophils, resolved within 15 days. No participant interrupted or stopped treatment because of an adverse event.2

In the Phase II SOLSTICE study, all 28 participants who completed 96 weeks had undetectable viral levels.2 An exploratory group of 10 people who stopped treatment after 96 weeks of suppression maintained a viral response through week 12 without rebound.2

Zura ends tibulizumab program after Phase II trial misses endpoints

Zura Bio discontinued tibulizumab for hidradenitis suppurativa after its 247-person TibuSHIELD study missed its primary and secondary endpoints.3 At week 16, abscess and inflammatory nodule counts fell by 58.1% and 56.0% in the two dose groups, close to the 52.5% reduction with placebo.3 Secondary measures, including HiSCR50 and HiSCR75, also showed no meaningful separation from placebo.3

One participant in the higher-dose group died of cardiac arrest. The site investigator judged the death unrelated to treatment and cited multiple cardiovascular risk factors.3 Zura plans to continue testing tibulizumab in systemic sclerosis, with topline Phase II results expected in the first half of 2027.3

Also worth knowing

• 

  After one dose of its CIDEB-targeting siRNA, Regeneron reported liver-fat reductions of 58% to 80% at week 36 across dose groups, compared with 2.9% with placebo, in a Phase I/II MASLD study.4

• P

  START and Rome’s Regina Elena National Cancer Institute are partnering to establish an early-phase oncology trial site in Italy, START’s first in the country.5

Also published

• ACT Brief: China’s Startup Timelines, AI-Drafted Clinical Study Reports, and Bimzelx Psoriatic Arthritis Data Applied Clinical Trials
• Where AI Can Strengthen Clinical Research, and Where Patient Input is More Important Pharmaceutical Executive
• <b>Next-generation KRAS G12C inhibitor improves survival in lung cancer</b> Nature Medicine
• Vir hepatitis D drug succeeds in first pivotal study BioPharma Dive
• Novartis' pelacarsen fail raises questions for other drugs pharmaphorum