MediciNova Receives Notice of Approval from United States Patent and Trademark Office for Patented New Product MN-166 (ibudilast) for Post-COVID Context
LA JOLLA, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that it has received a Consent Notice from the US Patent and Trademark Office for a pending patent application, covering MN-166 (ibudilast) for post-COVID conditions. The patent's Method of Use includes administering therapeutically effective doses of ibudilast (or a pharmaceutically acceptable salt thereof) to alleviate a range of post-COVID conditions including anxiety, fatigue, depression, shortness of breath, post-traumatic stress disorder, chest tightness, palpitations, smell or taste dysfunction, difficulty sleeping, hair loss, and rashes.
The invention allows MN-166 (ibudilast) to be administered alone or in combination with other active agents, including corticosteroids, NSAIDs, SSRIs, and more. Approved claims include oral administration, intravenous administration, subcutaneous injection, intramuscular injection, and inhalation administration. Allowed claims include a wide range of dosages, different dosage ranges, and a range of different treatment times. Once issued, this patent is expected to expire before November 2042.
Kazuko Matsuda, MD, Ph.D., MPH, MediciNova's Chief Medical Officer commented, This additional patent for ibudilast provides additional opportunities for us to maintain exclusivity in areas where research continues. We are dedicated to addressing the complex and ongoing health challenges posed by COVID-19 through key partnerships, such as our current collaboration with University Health Network in Canada, where a Phase 2/3 clinical trial in Long COVID is underway. We believe that ibudilast may offer hope to millions of patients suffering from post-COVID conditions, providing a flexible and effective treatment option. As we are committed to moving forward with the New Drug Application when the study shows a positive effect, we plan to initiate a discussion with Health Canada when the RECLAIM study shows positive data.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule combination 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 is being developed for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorders. In addition, MN-166 (ibudilast) was evaluated in patients at risk of developing acute respiratory distress syndrome (ARDS).
About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing an extensive pipeline of late-stage 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 product, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being tested in Phase 2 trials for chronic COVID and drug addiction. MN-001 (tipelukast) was tested in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of obtaining investigator-sponsored clinical trials funded by federal grants.
Statements in this press release that are not historical in nature include forward-looking statements within the meaning of the safe harbor provisions of the Private Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and performance of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or include the words “believes,” “anticipates,” “anticipates,” “intends,” “estimates,” “projects,” “may,” “could,” “may,” “will,” “would like,” consider, plan 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, but are not limited to, risks of finding a future partner or financing for the development of MN-166, MN-001, MN. -221, and MN-029 and the risks of raising sufficient capital when necessary to fund MediciNova's operations and contribute to clinical development, the risks and uncertainties inherent in clinical trials, including the potential costs, expected timing and risks associated with clinical trials designed to meet the FDA the direction and possibility of further development considering these factors, product development and marketing risks, uncertainty as to whether the results of clinical trials will predict results in the later stages of product development, the risk of delay or failure to obtain or maintain regulatory approval. , risks related to reliance on third parties to sponsor and fund clinical trials, risks related to intellectual property rights in product candidates and the ability to protect and enforce those intellectual property rights, risks of failure of third parties MediciNova relies on to conduct its clinical trials and make its candidate products perform as expected , the risk of increased costs and delays due to delays in the initiation, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or clinical conduct. trials, and the timing of expected filings with regulatory authorities, MediciNova's interactions with third parties, the availability of funds to complete product development programs and MediciNova's ability to obtain third-party financing for programs and to raise sufficient capital when needed, as well as other risks and uncertainties described in MediciNova's filing with -Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its 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 their date. MediciNova disclaims any intention or obligation to revise or update these forward-looking statements.
CONTACTING THE DRIVER:
David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com
