Widetrial to manage physician network for ibudilast EAP
NIH-funded program offers access to patients ineligible for clinical trials
Widetrial, an integrated service and technology platform, is coming on board to support an expanded access program (EAP) that will provide the investigational therapy MN-166 (ibudilast) to amyotrophic lateral sclerosis (ALS) patients who aren’t eligible for clinical trials.
The program is funded under a $22 million federal grant given to the Mayo Clinic in Florida. It will enroll about 200 ALS patients at three Mayo Clinic sites — in Minnesota, Florida, and Arizona — as well as other participating U.S. institutions. Interested patients can fill out an expression of interest form online.
Widetrial is helping to manage and expand the network of ALS specialists involved in the study. The goal is to grow the diversity of locations and patient backgrounds that can be included in the program by getting more physicians involved.
“At WideTrial, we believe every patient deserves a chance to explore potential therapies, regardless of their eligibility for traditional research trials,” Jess Rabourn, CEO of Widetrial, said in a company press release. “The collaboration is part of our commitment to empowering patients and providers with solutions that democratize access to research-stage medicines.”
Clinical trials for new therapies often have stringent inclusion and exclusion criteria, leaving many patients ineligible to participate based on various factors. EAPs, sometimes referred to as compassionate use programs, are intended to provide access to investigational therapies for patients with serious and life-threatening illnesses who are unable to participate in clinical trials.
Ibudilast trial
In addition to providing a greater number of patients with potentially lifesaving or life-extending treatment, EAPs offer researchers additional opportunities to collect clinical data on experimental therapies.
The Accelerating Access to Critical Therapies for ALS Act, known as ACT for ALS, was signed into law in 2021 and called for a federally funded grant mechanism for ALS EAP programs. The MN-166 program is funded under this mechanism. MediciNova is developing MN-166 to treat ALS and will provide the medication for the EAP study.
Ibudilast, the active ingredient in the oral therapy, is designed to reduce immune cell activity in the brain, thereby preventing inflammatory damage that’s believed to drive neurodegeneration in ALS. This is expected to help boost nerve cell survival and slow disease progression.
In a previous Phase 2 trial (NCT02238626), MN-166 used as an add-on to the approved ALS therapy Rilutek (riluzole) was associated with a higher proportion of patients seeing stabilizations or improvements in measures of disease severity and quality of life relative to Rilutek alone. It also tended to extend survival.
The EAP study will include ALS patients who are not able to enroll in ongoing clinical trials of MN-166. It mainly aims to measure the treatment’s effects on disease progression and levels of neurofilament light chain (NfL), a biomarker of nerve cell damage, over six months of treatment. A therapy’s ability to lower NfL levels is generally believed to reflect its potential for slowing disease progression.
Unique to this study is that patients will be able to monitor their own NfL levels throughout the trial. Blood samples will also be stored and used to establish an ALS biobank for future research.
“We are pleased to support this important initiative to expand access to investigational ALS treatments,” Rabourn said.
Meanwhile, MediciNova is sponsoring a Phase 2b/3 clinical trial called COMBAT-ALS (NCT04057898) that will test MN-166 against a placebo in about 230 ALS patients. It’s recruiting participants at locations in the U.S. and Canada.
About the Author
