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WideTrial Celebrates Enrollment Completion for MN-166 in ALS

In a remarkable stride towards advancing treatment accessibility for Amyotrophic Lateral Sclerosis (ALS) patients, WideTrial has successfully completed the planned enrollment for its Expanded Access Program (EAP) designed for the investigational drug MN-166 (ibudilast). Launched in 2025, the program known as Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS (SEANOBI-ALS) reached its target of 200 participants within just 13 months.

The SEANOBI-ALS initiative was specifically crafted to ensure that individuals with ALS, who found themselves ineligible for conventional clinical trials due to stringent eligibility criteria or geographical restrictions, would still have access to promising treatment options. This program was made possible thanks to collaborative efforts with a prominent academic medical center and financial backing from the ACT for ALS initiative, administered by the National Institute of Neurological Disorders and Stroke (NINDS).

Remarkable Participation Across the Nation

Since the enrollment of its first patient in March 2025, SEANOBI-ALS has successfully included participants from 27 states, facilitated through a network of 15 dedicated ALS clinics across the United States. The overwhelming interest in the program highlights the critical need for alternative access routes to therapies for ALS patients, particularly when traditional research studies are not feasible for various reasons.

The swift achievement of full enrollment signifies not only the feasibility of such Expanded Access Programs but also their importance in addressing the treatment gaps experienced by ALS patients and the dedication of involved healthcare professionals. The need for accessible treatment options remains paramount as patients and their families strive for every opportunity to manage this devastating disease.

Continuing the Journey

For the patients currently enrolled in SEANOBI-ALS, the journey doesn’t end with enrollment. Participants will continue receiving treatment alongside follow-up care according to the established program protocol. The final follow-up phase is expected to wrap up by early 2027. Upon completion, the data gathered will undergo a thorough analysis to facilitate future scientific discussions and publications surrounding ALS treatment and care.

In the coming months, WideTrial is eager to disseminate further insights as they become available from the program's findings. The expansive engagement from both patients and clinics had propelled SEANOBI-ALS to reach its enrollment goals at an impressive pace, revealing a hopeful narrative for those fighting ALS.

What Lies Ahead

Looking forward, WideTrial is not resting on its laurels. With a robust commitment to expanding treatment accessibility, the organization is currently assessing additional prospects for future Expanded Access Programs, predicting at least one more major EAP launch targeted for 2027. They encourage patients and clinics that were unable to join SEANOBI-ALS to stay attuned for upcoming opportunities, both grant-sponsored under ACT for ALS and those supported by industry collaborators.

Understanding Expanded Access Programs

EAPs represent a critical pathway authorized by the FDA, enabling access to experimental medications for patients facing serious health challenges who do not have other viable treatment options. SEANOBI-ALS was designed not only to provide access but also to mitigate the burden on clinical staff compared to traditional research trials. Importantly, these programs also aim to collect invaluable data identifying patient demographics that may benefit most from the innovative treatments being trialed.

About WideTrial

WideTrial stands at the forefront of advocating for treatment accessibility, driven by individuals who personally comprehend the harrowing impact ALS has on patients and families. Their mission is to integrate well-managed Expanded Access Programs into the healthcare landscape at scale, ensuring that all those affected by serious or life-threatening diseases can explore potential treatment avenues. For additional information or inquiries, interested parties can reach out to WideTrial via their published contact details.

For media inquiries, please contact:
Shona Allen
Clinical Programs Director
Phone: (650) 715-7500
Email: [email protected]