LA JOLLA, Calif., May 5, 2021 (GLOBE NEWSWIRE) – MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market (NASDAQ: MNOV) and the Tokyo Stock Exchange’s JASDAQ Market (code number: 4875), announced today that it has received a notice of intention to grant from the European Patent Office for a pending patent application covering the combination of MN-166 (ibudilast) and riluzole for the treatment of amyotrophic lateral sclerosis ( SLA).
Once granted, the expiring patent of this authorized patent application is expected to expire no earlier than November 2035. The authorized claims cover the combination of MN-166 (ibudilast) and riluzole for use in a method of treating a. patient with ALS in which the treatment results in stabilization of the patient’s sclerosis state. The permitted claims cover a wide range of doses and dosage schedules for MN-166 (ibudilast) and riluzole.
Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc., said, âWe are very pleased to receive notice that this new patent will be granted. Previously, similar patents were granted in the United States. and Japan based on data from our first ALS patent clinical trial. We previously announced the results of a “responder analysis” which found that the proportion of responders, defined as stable or improved in the ALSAQ-5 functional score, muscle test and subjective assessment of quality of life, was higher in the MN-166 plus riluzole group compared to the riluzole alone group. We believe this new patent could dramatically increase the potential value of MN-166. We are currently conducting a Phase 3 clinical trial with ALS patients in the US and Canada using MN-166 plus riluzole. The US FDA has granted both the of Orphan Drug Submission and Expedited Designation to MN-166 for the treatment of ALS, and the European Commission has granted orphan medicinal product designation to MN -166 for the treatment of ALS. “
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. The nerves lose the ability to trigger specific muscles, which weakens the muscles. As a result, ALS affects voluntary movement and patients in the later stages of the disease can become completely paralyzed. The life expectancy of an ALS patient is usually 2 to 5 years. According to the ALS Association, there are approximately 16,000 patients with ALS in the United States and approximately 5,000 people in the United States are diagnosed with ALS each year.
About MN-166 (ibudilast)
MN-166 (ibudilast) is an orally bioavailable small molecule macrophage migration inhibitor factor (MIF) and phosphodiesterase (PDE) -4 and -10 inhibitor which suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Our previous human studies have demonstrated significant reductions in serum MIF levels after treatment with MN-166 (ibudilast). It also attenuates activated glial cells, which play a major role in certain neurological conditions. The anti-neuroinflammatory and neuroprotective actions of MN-166 (ibudilast) have been demonstrated in preclinical and clinical studies, which support the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS) and others. neurological diseases such as glioblastoma (GBM) and substance abuse / addiction. MediciNova is developing MN-166 for ALS, progressive MS, and other neurological conditions such as degenerative cervical myelopathy (DCM), glioblastoma, drug addiction / dependence, and chemotherapy-induced peripheral neuropathy, as well as prevention of Acute Respiratory Distress Syndrome (ARDS)) caused by COVID-19. MediciNova has a portfolio of patents that covers the use of MN-166 (ibudilast) to treat various diseases, including ALS, progressive MS, and drug addiction.
MediciNova, Inc. is a publicly traded biopharmaceutical company founded on the development of novel small molecule therapies for the treatment of diseases with unmet medical needs with a primary business focus in the US market. MediciNova’s current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), degenerative cervical myelopathy (DCM), addiction substances (eg (IPF). MediciNova’s pipeline also includes MN-221 (bedoradrine) and MN-029 (denibulin). For more information about MediciNova, Inc., please visit www.medicinova.com.
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 effectiveness of MN-166, MN-001, MN-221 and MN-029. These forward-looking statements may be preceded, followed by or include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “plans”, “may”, “could,” âMayâ, âwillâ, âwouldâ, âconsiderâ, âplanâ or similar expressions. These forward-looking statements involve a number of risks and uncertainties which 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 such forward-looking statements include, but are not limited to, the risks of obtaining future partners or development grants. MN-166, MN-001, MN -221 and MN-029 and the risks of raising sufficient capital when necessary to finance the operations of MediciNova and its contribution to clinical development, the risks and uncertainties inherent in clinical trials, including including the potential cost, expected schedule and risks associated with clinical trials designed to meet FDA directions and the viability of further development given these factors, risks associated with product development and commercialization, uncertainty As to whether the results of clinical trials will be predictive of results in later stages of product development, the r isk of delays or failure to obtain or maintain regulatory approval, risks associated with relying on third parties to sponsor and fund clinical trials, risks regarding information, intellectual property rights to product candidates and capacity to defend and enforce these intellectual property rights, the risk of failure of third parties on which MediciNova relies to conduct its clinical trials and manufacture its product candidates to function as intended, the risk of increased costs and delays due to delays in the initiation, recruitment, completion or analysis of clinical trials or to significant issues regarding the suitability of clinical trial designs or the execution of clinical trials, and the timing expected deposits with regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to carry out disaster recovery plans product development and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when required, and other risks and uncertainties described in documents filed by MediciNova with the Securities and Exchange Commission, including including its annual report on Form 10-K for the year ended December 31, 2020 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Do not place undue reliance 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.