WideTrial Provides Update on NIH-Funded Expanded Access Program for Investigational ALS Drug MN-166

Program expands patient access to ibudilast at multiple ALS centers across the U.S

SANTA CLARA, CA, UNITED STATES, July 10, 2025 /EINPresswire.com/ -- WideTrial, an innovator of Expanded Access Program (EAP) solutions, today provided an update on its NIH-funded Expanded Access Program, SEANOBI-ALS, delivered in partnership with a large academic medical center. The program provides investigational drug MN-166 (ibudilast) to ALS patients who cannot participate in traditional clinical trials.

To support this program, the National Institute of Neurological Disorders and Stroke (NINDS) has awarded the EAP’s Sponsor—the academic medical center—a grant under the ACT For ALS Act of 2021. The grant supports the inclusion of up to 200 ALS patients at multiple ALS clinics nationwide, each receiving MN-166 treatment for up to six months.

The first treatment location, Mayo Clinic Jacksonville, has enrolled 15 patients as of the end of June 2025. Two (2) additional locations, Mayo Clinic Rochester and Mayo Clinic Arizona, will begin enrolling patients in July. Five (5) more clinical sites have been invited to join and each of the five has begun the onboarding process. An additional eight (8) pre-selected clinics will be invited this summer, and each clinic that completes its onboarding steps by the end of 2025 will be granted openings for at least 5 patients. The list of clinics to be invited in 2025 includes all nine (9) U.S. sites of the COMBAT-ALS Phase 2/3 research trial for MN-166.

As expected, the demand for access to this EAP far surpasses the budgeted capacity of 200 patients. Therefore, WideTrial and the Sponsor continue to work together to get the program scope increased. This includes continuous dialog with the outside parties who determine the maximum number of patients and the duration of treatment permitted under this EAP.

Although each participating clinic makes its own enrollment decisions, WideTrial will provide participating clinics with the contact details of patients in their region who have expressed interest via the WideTrial website and who have consented to information sharing.

About Expanded Access Programs (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 integrated service and technology platform that delivers scalable, group-level Expanded Access programs (EAPs) that are easy to participate in and improve patient access to investigational treatments. The company's mission is to bridge the gap between patients and potentially life-saving therapies by streamlining and simplifying the EAP process. WideTrial's expertise and commitment to patient-centric solutions enable healthcare providers and drug developers to efficiently and compliantly offer expanded access to investigational drugs. To learn more, visit widetrial.com.

Tim Cox
ZingPR for WideTrial
tim@zingpr.com
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