Groundbreaking Step for ALS Patients with MN-166 Access Trial

MediciNova Takes Major Step in ALS Treatment with Expanded Access

In a pivotal move for the ALS community, MediciNova, Inc., a leading biopharmaceutical company listed on NASDAQ under the ticker MNOV, has enrolled its first patient in the NIH-funded Expanded Access Program (EAP) trial. This trial focuses on evaluating the potential of MN-166 (ibudilast) as a treatment for individuals grappling with Amyotrophic Lateral Sclerosis (ALS).

Significance of the Expanded Access Program Trial

This enrollment marks a significant moment, providing hope to ALS patients sidelined from the ongoing Phase 2/3 COMBAT-ALS trial. The EAP is a crucial initiative funded by the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS). The trial aims to assess the safety and effectiveness of MN-166 in approximately 200 ALS patients, offering a lifeline to those who need it most.

Dr. Yuichi Iwaki on the Trial

Dr. Yuichi Iwaki, President and CEO of MediciNova, expressed heartfelt appreciation for the ongoing support from the NIH and NINDS. He stated, "This trial will allow more individuals in the later stages of ALS to access MN-166, a treatment we firmly believe in. Our gratitude extends to the participants, their families, and the devoted healthcare teams making this EAP a reality. We are excited to embark on this journey with them."

Understanding MN-166 (Ibudilast)

MN-166, also known as ibudilast, is a small molecule compound with notable effects on phosphodiesterase type-4 (PDE4) and inflammatory cytokines such as macrophage migration inhibitory factor (MIF). It is currently in late-stage clinical development for various neurodegenerative conditions, including ALS, progressive MS, and degenerative cervical myelopathy (DCM). In addition, the compound is being explored for its efficacy in treating glioblastoma, Long COVID, and chemotherapy-induced peripheral neuropathy.

Regulatory Designations for MN-166

The U.S. FDA has granted Orphan Drug Designation to MN-166 for ALS and has also recognized it with Fast Track Designation for gauging its potential in treating this debilitating condition. Furthermore, the compound has received Orphan Disease Designation for tackling glioblastoma, underscoring its diverse therapeutic applications.

About MediciNova and Its Commitment to Innovation

MediciNova, Inc. is at the forefront of biopharmaceutical innovations, developing small molecule therapies targeting inflammatory, fibrotic, and neurodegenerative diseases. With a robust pipeline comprising 11 clinical programs, MediciNova is dedicated to addressing unmet medical needs through advanced research and development. The company's flagship asset, MN-166, is being evaluated in multiple clinical trials, indicating its significant potential in therapeutic areas.

Broader Impact of Clinical Research

The persistent efforts of MediciNova to innovate reflect the broader advancements in clinical research aimed at improving patient outcomes in challenging medical situations. By securing government funding for investigator-led trials, MediciNova continues to push the boundaries of what’s possible in ALS and other neurodegenerative conditions.

Frequently Asked Questions

1. What is the objective of the Expanded Access Program trial for MN-166?

The trial aims to evaluate the safety and efficacy of MN-166 in ALS patients who are not eligible for the ongoing Phase 2/3 COMBAT-ALS trial.

2. Who is conducting the Expanded Access Program trial?

The Expanded Access Program trial is being funded and conducted under the auspices of the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS).

3. What is MN-166 and how does it work?

MN-166, also known as ibudilast, is an oral small molecule that inhibits PDE4 and inflammatory cytokines, and is being studied for its effects on various neurodegenerative diseases.

4. What are the regulatory recognitions that MN-166 has received?

MN-166 has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA for its potential in treating ALS and Orphan Disease Designation for glioblastoma.

5. How does MediciNova support its clinical programs?

MediciNova actively seeks government grants to fund investigator-sponsored clinical trials, reflecting its commitment to advancing innovative therapeutic options.

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