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Program to provide investigational drug to ALS patients who would otherwise be ineligible for clinical trials SANTA CLARA, Calif. , Nov. 20, 2024 /PRNewswire/ -- WideTrial , an innovator of expanded access program (EAP) solutions, announced its participation in an NIH-funded collaboration to provide pre-approval access to an investigational ALS drug.
The program will offer access to ibudilast, an experimental drug being studied for its potential to slow the progression of ALS, to patients who are ineligible for clinical trials. The program is funded by a $22 million grant from the National Institute of Neurological Disorders and Stroke (NINDS) and will be led by Dr. Bjorn Oskarsson at Mayo Clinic's ALS Center of Excellence in Jacksonville, Florida .
It aims to enroll 200 ALS patients across all three Mayo Clinic centers and other participating institutions. WideTrial will support the program by engaging a growing group of ALS specialists, enabling greater diversity of patient location and background in the treatment program. The study aims to measure ibudilast's effect on ALS progression using a blood test that shows whether neurofilament protein levels have changed in patients with ALS.
High levels of neurofilament proteins may indicate damage in neurons. "We are pleased to support this important initiative to expand access to investigational ALS treatments," said Jess Rabourn , CEO of WideTrial. "At WideTrial, we believe every patient deserves a chance to explore potential therapies, regardless of their eligibility for traditional research trials.
The collaboration is part of our commitment to empowering patients and providers with solutions that democratize access to research-stage medicines." WideTrial's expertise in expanded access programs will help ensure the efficient and compliant implementation of the NIH-funded study. Expanded Access provides a pathway for patients with serious or life-threatening conditions who cannot participate in clinical trials to access investigational drugs.
Group-level Expanded Access Programs (EAPs) allow a greater number of patients and their physicians to explore a new investigational treatment under a well-designed protocol and supply chain, working in harmony with the continued clinical development of the treatment. When integrated into the drug development cycle, EAPs offer benefits such as wider patient engagement, increased chances of discovering response-predictive biomarkers, and information that leads to more targeted pivotal trials. 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 . Media Contact : WideTrail: Francis Greenleaf | [email protected] ZingPR for WideTrail: Tim Cox | [email protected] SOURCE WideTrial Inc..
