MediciNova announces in the Global Spine Journal that MN-166 (ibudilast) has been identified as a potentially beneficial pharmacotherapy for the treatment of degenerative cervical myelopathy

MediciNova, Inc.

LA JOLLA, Calif., Feb. 28, 2022 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (code number: 4875) announced today that MN-166 (ibudilast) has been discussed in the Global Spine Journal as a potentially beneficial pharmacological agent for the treatment of degenerative cervical myelopathy (DCM).

The publication, entitled Developing Novel Therapies for Degenerative Cervical Myelopathy [AO Spine RECODE-DCM Research Priority Number 7]: Opportunities from Restorative Neurobiology” and co-authored by MediciNova’s collaborator Dr. Mark Kotter, Professor, Neurosurgery Unit, Department of Clinical Neuroscience, University of Cambridge, UK, and colleagues discussed contemporary therapies that may have therapeutic value in three broad categories of neuroprotection, neuroregeneration and neuromodulation. Among those reviewed, the authors discuss the properties of MN-166 (Ibudilast) that support its use in DCM. The combination of the anti-inflammatory, neuroprotective, and neuroregenerative properties of MN-166 (ibudilast) is the basis for RECEDE myelopathy, a phase 3, double-blind, randomized, controlled study to evaluate its efficacy as an adjuvant treatment to decompression surgery in DCM on mJOA (modified Japanese Orthopedic Association) score and neck pain.

Key findings from the publication include:

  • Chronic spinal cord compression due to DCM leads to ischemia, neuroinflammation, demyelination, and neuronal loss.

  • People with DCM often develop lifelong disability and then suffer lifelong disability, with less than 5% fully recovering despite surgical decompression.

  • At the site of chronic spinal cord compression, an increase in activated microglia and macrophages has been observed, which is a source of pro-inflammatory cytokines and can lead to further cell death through necrosis and apoptosis.

  • MN-166 (Ibudilast) has been shown to exhibit central anti-inflammatory, neuroprotective and neurotrophic/neuroregenerative effects through inhibition of phosphodiesterase (PDE4 and PDE10) and macrophage migration inhibitory factor (MIF).

  • This combination of effects, resulting in a decrease in glial activation and an increase in neurotrophic/neuroregenerative factors, is a compelling reason to evaluate MN-166 (ibudilast) for the treatment of DCM.

  • MN-166 (ibudilast) is the only drug currently being evaluated in Phase 3 as a regenerative medicine for the treatment of DCM.

The story goes on

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, “We are encouraged that MN-166 (ibudilast) has been identified by this highly respected research team as a potentially beneficial pharmacotherapy for the treatment of DCM , a disease from which very few patients fully recover.”

About AO Spine RECODE-DCM Research Priority 7

The AO Spine RECODE-DCM is an international initiative to create a “research toolkit” to accelerate knowledge, discovery and outcomes in degenerative cervical myelopathy. It has 10 research priorities. The seventh of these is defined as “Advanced Therapies”. This article is published as part of a series of AO Spine RECODE-DCM reviews presented in the Global Spine Journal.

About degenerative cervical myelopathy

According to, degenerative cervical myelopathy (DCM) is defined as compression of the spinal cord in the neck that can lead to paralysis. DCM is a common, progressive neurological disease caused by aging, arthritis, and degenerative spinal diseases such as spinal stenosis and central disc herniation. According to the American Association of Neurological Surgeons, more than 200,000 cervical surgeries are performed each year to relieve spinal cord or nerve root compression. Compression of spinal nerves results in neurological dysfunction such as numbness, tingling, pain and stiffness in the neck, and pain and numbness in the arms, fingers, or hands. Patients may experience muscular abnormalities, including but not limited to balance and walking problems, incoordination, muscle weakness in the arms, shoulders, or hands, rhythmic muscle spasms, stiff muscles, muscle wasting, overactive reflexes, and loss of bladder and bowel control. Depending on the severity of symptoms, options for treating DCM include a restraining collar, physical therapy, pain medication, muscle relaxants, and surgery. There is currently no cure and no approved drug to treat DCM.

Via MN-166 (Ibudilast)

MN-166 (Ibudilast) is a small molecule compound that inhibits phosphodiesterase type 4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis) and DCM (degenerative cervical myelopathy); and for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy) and substance use disorder. In addition, MN-166 (ibudilast) is being studied in patients at risk of developing acute respiratory distress syndrome (ARDS).

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad pipeline of novel small molecule therapies for late-stage inflammatory, fibrotic and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead compound, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is ready for Phase 3 for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being investigated in phase 2 studies in glioblastoma, patients at risk for developing acute respiratory distress syndrome (ARDS) and substance dependence. MN-001 (tipelukast) has been evaluated in a Phase 2 study in idiopathic pulmonary fibrosis (IPF) and is in preparation for a second Phase 2 study in nonalcoholic steatohepatitis (NASH). MediciNova has a strong track record of securing investigator-sponsored clinical trials funded by government grants.

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future performance and effectiveness of MN- 166, MN-001, MN-221 and MN-029. These forward-looking statements may be preceded, followed, or otherwise contained by the words “believe”, “expect”, “anticipate”, “intend”, “estimate”, “project”, “may”, “could”. may”, “will”, “would”, “considers”, “plans” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, among others, the risk of obtaining future partners or funding for the development of MN-166, MN-001 , MN-221 and MN-029 and risks of raising sufficient capital if necessary to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties associated with clinical trials, including potential costs , the expected timing and risks associated with clinical trials designed to meet the requirements of the FDA guidelines and the feasibility of further development taking into account these factors, product development and commercialization risks, the uncertainty of whether clinical trial results will meet the Results i n later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with reliance on third parties to sponsor and fund clinical trials, risks related to Intel intellectual property rights in product candidates and the ability to defend and enforce these intellectual property rights, the risk of failure of the third parties on which MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased costs and delays due to Delays in the initiation, registration, completion or analysis of clinical trials or significant issues related to the adequacy of clinical trial design or conduct of clinical trials and the timing of expected regulatory submissions, ie e MediciNova’s collaboration with third parties, the availability of funds to execute product development plans and MediciNova’s ability to obtain third-party funding for programs and to raise sufficient capital when needed, and the other risks and uncertainties inherent in MediciNova’s securities and Exchange Commission filings, including the annual report on Form 10-K for the year ended December 31, 202 1 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date of this release. MediciNova disclaims any intention or obligation to revise or update these forward-looking statements.


Geoff O’Brien

Vice President

MediciNova, Inc.

[email protected]