Access to investigational ALS therapy MN‑166 expanded further
2 more sites will begin enrolling patients not eligible for clinical trial
The ongoing program that is providing amyotrophic lateral sclerosis (ALS) patients with access to Medicinova’s investigational therapy MN‑166 (ibudilast) outside of a clinical trial is adding new sites.
The expanded access program (EAP) will enroll about 200 patients at several locations in the U.S. who are not eligible for the ongoing COMBAT-ALS trial (NCT04057898), including those with more advanced disease.
To date, the Mayo Clinic Jacksonville has enrolled 15 patients. Two additional locations, the Mayo Clinic Rochester and Mayo Clinic Arizona, will begin enrolling this month. Five additional clinics have been invited, and each has begun the onboarding process. Another eight clinics will be invited this summer, and each clinic that completes its onboarding steps by the end of this year will be granted openings for at least five patients.
Notably, the list of clinics to be invited this year includes all nine U.S. sites where the Phase 2b/3 COMBAT-ALS trial is ongoing.
The recent update was provided by Widetrial, which is helping to manage and expand the network of ALS specialists and clinics involved in the SEANOBI‑ALS EAP study.
SEANOBI-ALS study could lead to more personalized treatment
EAPs, also known as compassionate use programs, are designed to help people with serious or life-threatening conditions access experimental therapies outside of traditional clinical trials when no other alternatives are available.
SEANOBI-ALS is funded under a $22 million federal grant given to the Mayo Clinic in Florida by the National Institute of Neurological Disorders and Stroke, which is part of the National Institutes of Health.
Participants will receive MN-166 up to six months. The main goals are to determine changes in disease progression and in neurofilament light chain levels, a biomarker of nerve cell damage. Data gathered from this study will also be used to identify patients who are more likely to respond to MN-166, which may possibly allow for more personalized treatment.
As the demand for access to this EAP significantly exceeds the planned capacity of 200 patients, WideTrial and the program sponsor are actively collaborating to expand the program’s scope. Conversations are underway with external stakeholders who dictate the maximum number of patients and duration of treatment under this EAP.
While each participating clinic is responsible for making its own enrollment decisions, Widetrial will provide clinics with the contact information of patients in their area who have demonstrated interest in participating through the WideTrial website.
Interim analysis suggests MN-166 may slow ALS progression
MN-166 aims to reduce the activity of immune cells in the brain, which may help prevent inflammation and nerve cell damage in ALS. This is expected to slow down disease progression.
In a previous Phase 2 trial (NCT02238626), using MN-166 as an add-on to riluzole oral tablets (formerly sold as Rilutek, now available as generics only) led to a higher proportion of patients with stable or less severe disease compared to those on riluzole alone. It also tended to extend survival.
MediciNova is now sponsoring COMBAT-ALS, which is evaluating MN-166 in about 230 adults who began experiencing ALS symptoms up to 1.5 years before entering the study. Participants are being given either MN-166 or a placebo twice daily for 12 months, after which all participants will be given the option to enter a six-month open-label extension.
An interim analysis has suggested that MN-166 may slow ALS progression, extend survival, and reduce the decline in key physical functions, but more data will be needed to know for sure if the experimental therapy has an impact on those measures.
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