6 April 2026
We are delighted to share that recruitment was completed for the Phase 2 ASTRALS clinical trial in 2025. The trial enrolled 251 participants across the globe.
What is ASTRALS?
ASTRALS is a Phase 2 clinical trial that is studying the effects of a drug called VHB937 in people living with ALS.1 The goal is to see how well the drug impacts the disease and how safe it is. Novartis has partnered with expert physicians, people living with ALS, care partners, and patient organizations to guide the design of this trial and have included their feedback wherever possible.
How does VHB937 work?
VHB937 is an experimental monoclonal antibody treatment being studied for people living with ALS. It targets TREM2, a receptor protein found on the outer membrane of microglia, which are immune cells that play an important role in removing dead and damaged cells, fighting off infections, and repairing the brain after injury.2 Although many of the functions of microglia are helpful, their overactivity, as observed in ALS, may lead to the release of harmful substances that become toxic and cause damage to the brain. By targeting TREM2, VHB937 is designed to work with the body’s immune system, targeting overactive and toxic microglia. By this, we aim to further understand how and whether this targeting can influence microglia responses – with the hope that this may help them return to their protective form and function.
How does the trial work?
• ASTRALS is a randomized, double-blind, placebo-controlled study.1 This means that participants are randomly assigned to receive either the drug or a placebo (at a 2:1 ratio of drug to placebo), and neither the participants nor the researchers know who is receiving which treatment.
• The trial lasts for 40 weeks, followed by an open label extension (OLE) study. 1 After 40 weeks, all participants have the opportunity to receive the drug in the OLE period, which continues until 60 weeks after the last participant receives the first treatment in the OLE.
• The treatment will be given through an intravenous (IV) infusion every 4 weeks and takes place at the study site with each infusion typically lasting a few hours.1
What is measured?
• The study looks at how long participants survive without needing permanent help to breathe from a machine (i.e., permanent assisted ventilation free survival), as well as the change in a scale measuring daily functional abilities called the ALSFRS-R.1
• Preliminary results from the study are expected to be shared at a medical congress in late 2026/early 2027 but this is subject to the availability and interpretation of the data.
Full details of the study can be found here.
We understand the significant impact that ALS has on individuals, families, and caregivers. Research studies like ASTRALS are only possible because of the commitment and partnership of the ALS community with trial sites and Novartis. We are deeply grateful to everyone who contributes to advancing research, whether through participation, advocacy, or support.
Novartis remains committed to transparency and collaboration with the ALS community, and sharing updates as our research continues. If you have any questions, please contact us at the email below.
Kind regards,
The Novartis ASTRALS Study Team
For more information, please contact Novartis Medical Information (US): medinfo.gtx@novartis.com, 1-833-828- 3947
1 ALSFRS-R = Revised Amyotrophic Lateral Sclerosis Functional Rating Scale
Disclaimer- VHB937 is currently an experimental treatment and has not been approved for use by the FDA or other regulatory authorities
References:
- ClinicalTrials.gov. Study of VHB937 in Amyotrophic Lateral Sclerosis (ALS) (NCT06643481). https://clinicaltrials.gov/study/NCT06643481. Accessed March 2026.
- Pocock J, Vasilopoulou F, Svensson E, Cosker K. Microglia and TREM2. Neuropharmacology. 2024; 257:110020. doi: 10.1016/j.neuropharm.2024.110020.
Source: Novartis