MediciNova to Meet with U.S. FDA to Discuss Clinical Development of a Parenteral Formulation of MN-166 (ibudilast)
MediciNova has completed a Phase I clinical trial of MN-166 (ibudilast), showing a favorable safety and tolerability profile in healthy volunteers. The intravenous (IV) formulation was well tolerated, with no concerning adverse events reported. This formulation targets inflammatory disorders such as acute respiratory distress syndrome (ARDS) and offers a treatment option for hospitalized patients unable to take oral medication. The company is seeking FDA guidance for future development and potential approval of this formulation.
- Phase I trial results show favorable safety and tolerability for the IV formulation of MN-166.
- No concerning adverse events reported; all adverse events were mild.
- The IV formulation aims to address ARDS and is suitable for patients unable to swallow capsules.
- The company plans to seek FDA guidance for clinical development and approval.
- None.
MN-166 (ibudilast) parenteral formulation showed a favorable safety and tolerability profile in healthy volunteers
LA JOLLA, Calif., Jan. 05, 2023 (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), today announced that a Phase I clinical trial to evaluate MN-166 (ibudilast) 10 mg intravenous (IV) infusion in healthy volunteers (HV) has been completed. The trial results yielded encouraging findings as MN-166 (ibudilast) was delivered intravenously to HV with a favorable safety profile and was well tolerated. There were no concerning adverse events (AEs), all reported AEs were mild, all study drug-related AEs were mild, and none of the AEs were unexpected.
This IV formulation of MN-166 (ibudilast) is being developed for inflammatory disorders, specifically prevention of acute respiratory distress syndrome (ARDS), sepsis, and cytokine release syndrome. In addition, the newly developed IV formulation will provide another option for health care providers to treat hospitalized patients and patients who are unable to swallow capsules.
Kazuko Matsuda, M.D., Ph.D, M.P.H., Chief Medical Officer, MediciNova, Inc., commented, “We are pleased with the results from this Phase I trial and are excited to evaluate the potential of the MN-166 parenteral formulation in acute and severe clinical settings that require fast bioavailability. A parenteral formulation will expand the clinical utility of MN-166 by enabling the treatment of indications for which the oral formulation is not suitable. We will seek guidance from the U.S. Food and Drug Administration to develop a plan to that may ultimately lead to FDA approval for 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 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) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).
About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline 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 (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through 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 development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” 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 such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, 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 expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when 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 year ended December 31, 2021 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 intent or obligation to revise or update these forward-looking statements.
INVESTOR CONTACT:
Geoff O'Brien
Vice President
MediciNova, Inc.
info@medicinova.com
FAQ
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