Updates About the Expanded Access Program for MN-166 in ALS
Program to provide investigational drug to ALS patients who would otherwise be ineligible for clinical trials
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
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: [email protected]
Media Contact:
Shona Allen
WideTrial, Clinical Programs Director
(650) 715-7500
[email protected]
View original content to download multimedia:https://www.prnewswire.com/news-releases/updates-about-the-expanded-access-program-for-mn-166-in-als-302811403.html
SOURCE WideTrial Inc.
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