Novartis stops ALS TREM2 stabilizer after Phase 2 miss, marking fourth trial setback in a month

Novartis has halted development of its TREM2 stabilizer VHB937, also known as lifonebart, for amyotrophic lateral sclerosis after the drug failed to meet either the primary or secondary endpoints in the Phase 2 ASTRALS trial of early‑stage patients.

The study used a composite primary endpoint that combined survival without the need for a ventilator and change on the ALS Functional Rating Scale‑Revised, and secondary measures included respiratory function decline and neurofilament light levels. VHB937 showed no advantage over placebo on any of these measures.

The setback comes on the heels of two late‑stage trial failures reported by Novartis last week and a pause on multiple CAR T cell programs following patient deaths, marking the company's fourth clinical disappointment in less than a month.