Program to provide investigational drug to ALS patients who would otherwise be ineligible for clinical trials

SAN JOSE, Calif., June 29, 2026 /PRNewswire/ -- WideTrial is pleased to share that the Expanded Access Program it launched in 2025, Scalable Expanded Access with Analysis of Neurofilament and other Biomarkers in ALS (SEANOBI-ALS), has reached its planned enrollment target. As a result, the program is no longer enrolling new patients.

SEANOBI-ALS was established to provide access to the investigational therapy MN-166 (ibudilast) for people living with ALS who are unable to participate in traditional clinical trials. The program is conducted in partnership with a large academic medical center and is supported by funding awarded under the ACT for ALS initiative through the National Institute of Neurological Disorders and Stroke (NINDS).

Enrollment Complete

Since enrolling its first patient in March 2025, SEANOBI-ALS has successfully enrolled 200 patients residing in 27 states through a network of 15 participating ALS clinics throughout the United States.

The strong interest in the program reflects the ongoing need for treatment access pathways for people living with ALS who do not qualify for conventional research studies due to eligibility criteria, geographic limitations, or other barriers to participation. SEANOBI-ALS swiftly reached full enrollment due to the commitment of participating sites and the strong engagement of patients and caregivers seeking access to investigational treatment options.

What Happens Next

Patients actively enrolled in SEANOBI-ALS will continue treatment and follow-up activities in accordance with the program protocol. Final patient follow-up activities are expected to conclude in early 2027, after which data collected through the program will be analyzed to support future scientific presentations and publications. WideTrial looks forward to sharing more as findings from the program become available.

Looking Ahead

Reaching 200 patients less than 13 months after first patient enrollment demonstrates both the feasibility and importance of scalable Expanded Access programs for people living with ALS.

Patients and clinics who tried but were unable to participate in SEANOBI-ALS are encouraged to continue checking with WideTrial about future EAPs, both grant-sponsored under ACT for ALS and industry-sponsored.  WideTrial is now evaluating new Expanded Access opportunities in ALS and anticipates launching at least one additional large EAP in 2027.

About EAPs: Expanded Access programs (EAPs) are a type of FDA-authorized clinical trial that prioritizes experimental treatment access for patients with serious conditions who lack other meaningful, potentially disease-modifying treatment options – particularly patients who cannot get into research trials of new medicines due to inclusion/exclusion criteria or difficulty traveling to trial sites.

About this EAP: SEANOBI-ALS was designed for swift activation of participating clinics and minimal-burden on clinical staff, in comparison to research trials. This program's secondary objective is to generate valuable data about the kinds of patients who may benefit most from the experimental treatment.

About WideTrial: WideTrial is an emerging company with the mission of making experimental treatment options accessible to all people with serious or life-threatening diseases. The team is personally aware of the devastating toll ALS takes on patients and families and is relentlessly committed to integrating well-managed EAPs into healthcare at meaningful scale.

For inquiries, please contact WideTrial via email: community@widetrial.com

Media Contact:

Shona Allen
WideTrial, Clinical Programs Director
(650) 715-7500
community@widetrial.com

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SOURCE WideTrial Inc.