MediciNova initiates clinical evaluation of a new parenteral formulation of MN-166 (ibudilast)


MediciNova, Inc.

LA JOLLA, Calif., July 21. 2022 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (code number: 4875), today announced the launch of a first-in-man clinical study aimed at evaluating the pharmacokinetics and bioavailability of a new parenteral formulation of MN-166 (ibudilast). The new MN-166 (ibudilast) formulation will provide an additional option for healthcare providers to administer MN-166 (ibudilast), in addition to the current oral formulation.

Kazuko Matsuda, MD, PhD, MPH, Medical Director of MediciNova, Inc., said, “We have been working on the development of an injectable formulation of MN-166 and are excited about this important milestone in our pharmaceutical development program. . This new formulation allows the administration of MN-166 not only in acute settings to obtain a desired rapid effect of MN-166, but for indications requiring injections in specific locations such as intraocular, intra-articular and intrathecal. As MN-166 is expected to be effective in treating a variety of diseases, we believe that expanding to a parenteral formulation increases the feasibility of treating more target indications, thereby increasing the value of MN-166. »

About 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 advanced clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis) and DCM (cervical degenerative myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy) and substance use disorders. Additionally, MN-166 (ibudilast) has been evaluated in patients at risk of developing acute respiratory distress syndrome (ARDS).

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of novel small molecule therapies for 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 asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3 ready for progressive multiple sclerosis ( SEP). MN-166 (ibudilast) is also being evaluated in phase 2 trials in glioblastoma and substance dependence. MN-001 (tipelukast) has been evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and is in preparation for a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD). MediciNova has a strong track record of obtaining 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. Such forward-looking statements include, but are not limited to, statements regarding the future development and effectiveness of MN-166, MN-001, MN-221 and MN-029. These forward-looking statements may be preceded, followed or otherwise include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “projects”, “may”, “could”. ‘, ‘may’, ‘will’, ‘would’, ‘consider’, ‘plan’ or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the risks of obtaining a future partner or grant for the development of MN-166, MN-001, MN -221, and MN-029 and the risks of raising sufficient capital if needed to fund MediciNova’s operations and its contribution to clinical development, the risks and uncertainties inherent in clinical trials, including the potential cost, expected schedule, and risks associated with clinical trials designed to meet FDA requirements the direction and viability of further development considering these factors, the risks of developing and commercializing the product , uncertainty as to whether clinical trial results will be predictive of results at later stages of product development, risk of delay ds or failure to obtain or maintain regulatory approval, risks associated with the use of third parties to sponsor and fund clinical trials, risks regarding information, intellectual property rights in product candidates and the ability to defend and to enforce these intellectual property rights, the risk of default by third parties on which MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as intended, the risk of increased costs and delays due delays in the initiation, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of anticipated filings with regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and the MediciNova’s ability to obtain third-party funding for the programs and to raise sufficient capital if needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the fiscal 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 hereof. MediciNova disclaims any intention or obligation to revise or update these forward-looking statements.

Geoff O’Brien
vice president
MediciNova, Inc.
[email protected]


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