Lois Insolia ALS Clinic Opens Enrollment for New HEALEY ALS Platform Trial Regimen

Ashley RosenbrockFoundation Blog, Home Page, Research News

The Lois Insolia ALS Clinic at the Les Turner ALS Center at Northwestern Medicine is now an active site for Regimen F of the HEALEY ALS Platform Trial. The focus of Regimen F is ABBV-CLS-7262, an investigational product being developed by Calico Life Sciences LLC in collaboration with AbbVie. 

“Launching enrollment for this novel investigational product provides further hope towards discovering treatments for people living with ALS,” says Senda Ajroud-Driss, MD, Associate Professor of Neurology and Director of the Lois Insolia ALS Clinic at Northwestern University Feinberg School of Medicine. 

Dr. Ajroud-Driss will serve as national co-principal investigator for this study, showcasing the clinic’s position as a leader in providing access to clinical trials for people living with ALS. 

ABBV-CLS-7262 aims to restore function in cells affected by ALS by normalizing protein production and preventing further buildup of TDP-43. One of the most common problems in neurodegenration, TDP-43 pathology can be observed in more than 90% of ALS patients. ABBV-CLS-7262 is intended to aid in regulation of integrated stress response, which may help to prevent damage to neurons and possibly slow ALS progression.

Calico Life Sciences has produced a video to describe the science behind this novel therapy.

The first in-human study of ABBV-CLS-7262 showed that the drug was well-tolerated by participants and crossed the blood-brain barrier at concentrations predicted to be effective in ALS. With Regimen F, a phase 2/3 trial, investigators are seeking to enroll approximately 240 participants nationally. 

ABBV-CLS-7262 is the sixth regimen for the HEALEY ALS Platform Trial, which is the first of its kind for ALS. The Lois Insolia ALS Clinic has been a site for every regimen of the trial to date. 

Platform trials are designed to decrease the time it takes to find effective therapies, reduce the number of participants on placebo and increase access to research by conducting the same trial at multiple locations. One innovative feature of the platform trial approach is that enrollment remains ongoing as more investigational medications are added over time. 

For questions about the HEALEY ALS Platform Trial or other ALS clinical trials at the Lois Insolia ALS Clinic, contact Emma Schmidt, Clinical Research Coordinator, at emma.schmidt@northwestern.edu or (312) 503-4362.