LA JOLLA, Calif., Jan. 31, 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), today announced that it has received a Notice of Allowance from the Canadian Intellectual Property Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for hepatic ballooning.

加州拉霍亚，2022年1月31日(全球通讯社)——MediciNova, Inc.，一家生物制药公司，在纳斯达克全球市场(NASDAQ:MNOV)和东京证券交易所的JASDAQ市场(代码:4875)今日宣布，已收到加拿大知识产权局的专利申请补贴通知，该专利申请涵盖MN-001 (tipelukast)和MN-002 (MN-001的主要代谢物)，用于肝气球化。

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than January 2035. The allowed claims cover the use of MN-001 or MN-002 for inhibiting hepatic ballooning. The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms. The allowed claims cover a wide range of dosage strengths and dosing frequencies.

一旦获得批准，该专利将在2035年1月之前到期。允许的索赔包括使用MN-001或MN-002抑制肝脏膨胀。允许的权利要求包括口服，包括片剂和胶囊，以及液体剂型。允许的权利要求涵盖广泛的剂量强度和剂量频率。

Kazuko Matsuda, M.D. Ph.D, MPH., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased to receive notice that this new patent will be granted in Canada in addition to the upcoming issuance of a similar patent in Europe. Hepatocyte ballooning is a component of the Nonalcoholic Fatty Liver Disease (NAFLD) activity score. MN-001 improved NASH pathology by inhibiting hepatocyte ballooning in the NASH animal model and in the advanced NASH animal model. MN-001 demonstrated statistically significant improvements in the NAFLD activity score in both animal models.”

Kazuko Matsuda，医学博士，公共卫生硕士。MediciNova公司首席医疗官表示:“我们非常高兴地收到通知，除了即将在欧洲发布的类似专利外，这项新专利也将在加拿大获得批准。肝细胞球囊是非酒精性脂肪性肝病(NAFLD)活动评分的一个组成部分。MN-001通过抑制NASH动物模型和高级NASH动物模型中的肝细胞球囊化改善NASH病理。MN-001在两种动物模型中均显示了NAFLD活动评分的显著改善。”

About MN-001

mn - 001

MN-001 (tipelukast) is a novel, orally bioavailable, small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development, and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, histopathological data shows that MN-001 reduces fibrosis in multiple animal models.

MN-001 (tipelukast)是一种新型的口服生物利用小分子化合物，被认为在临床前模型中通过几种机制产生其抗炎和抗纤维化活性，包括白三烯(LT)受体拮抗，磷酸二酯酶(PDE)抑制(主要是3和4)，5-脂氧合酶(5-LO)抑制。5-LO/LT途径被认为是纤维化发生的致病因素，MN-001对5-LO和5-LO/LT途径的抑制作用被认为是治疗纤维化的一种新途径。MN-001已被证明可以下调促进纤维化的基因的表达，包括LOXL2，型胶原蛋白1和TIMP-1。MN-001也被证明可以下调包括CCR2和MCP-1在内的促进炎症的基因的表达。此外，组织病理学数据显示，在多种动物模型中，MN-001可减少纤维化。

About MediciNova

关于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, patients at risk of developing acute respiratory distress syndrome (ARDS), and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and is in preparation for a second Phase 2 trial in nonalcoholic steatohepatitis (NASH). MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

MediciNova, Inc.是一家临床阶段的生物制药公司，开发一种广泛的新型小分子治疗炎症、纤维化和神经退行性疾病的晚期管道。基于两种化合物，MN-166(异丁司特)和MN-001 (tipelukast)，具有多种作用机制和强大的安全性，MediciNova有11个临床开发项目。MediciNova公司的主要产品MN-166(异丁司特)目前处于肌萎缩性侧索硬化症(ALS)和退行性脊髓型颈椎病(DCM)的3期治疗阶段，也处于进行性多发性硬化(MS)的3期治疗阶段。MN-166(异丁司特)也在2期临床试验中被评估用于胶质母细胞瘤、急性呼吸窘迫综合征(ARDS)风险患者和物质依赖。MN-001 (tipelukast)在一项特发性肺纤维化(IPF)的2期试验中进行了评估，并正在准备用于非酒精性脂肪性肝炎(NASH)的2期试验。MediciNova在获得由政府资助的研究人员资助的临床试验方面有着良好的记录。

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, 2020 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.

本新闻稿中不具有历史性质的声明，在1995年《私人证券诉讼改革法案》的安全港条款的意义下构成前瞻性声明。这些前瞻性声明包括但不限于关于MN-166、MN-001、MN-221和MN-029未来发展和功效的声明。这些前瞻性陈述前后可加上“相信”、“预期”、“预期”、“打算”、“估计”、“项目”、“能”、“能”、“可能”、“将”、“将”、“考虑”、“计划”等词语或以其他方式包括在内。这些前瞻性陈述涉及若干风险和不确定性，这些风险和不确定性可能导致实际结果或事件与这些前瞻性陈述所表达或暗示的结果或事件有重大差异。可能导致实际结果或事件与这些前瞻性声明中所表达或暗示的存在重大差异的因素包括但不限于获得未来合作伙伴或开发MN-166、MN-001、MN-221、和MN-029，以及在需要为MediciNova的运营和临床开发提供资金时筹集足够资金的风险，临床试验固有的风险和不确定性，包括潜在成本，考虑到这些因素，产品开发和商业化风险，临床试验结果是否可预测产品开发后期结果的不确定性，延迟或未能获得或维持监管批准的风险，依赖第三方赞助和资助临床试验的相关风险，候选产品的知识产权风险，以及保护和执行这些知识产权的能力，MediciNova所依赖的第三方进行其临床试验和生产其候选产品以达到预期效果的失败风险，由于启动、注册的延迟而增加的成本和延迟的风险，完成或分析临床试验或有关临床试验设计或临床试验执行的充分性的重大问题，以及预期向监管当局提交文件的时间，MediciNova与第三方的合作，完成产品开发计划所需资金的可用性，MediciNova为项目获得第三方资金并在需要时筹集足够资金的能力，以及MediciNova提交给证券交易委员会的文件中描述的其他风险和不确定性，包括截至2020年12月31日的10-K表格的年度报告，以及随后的10-Q表格的定期报告和8-K表格的当前报告。不应过分依赖这些前瞻性声明，这些声明仅在本协议日期生效。MediciNova拒绝任何意图或义务修订或更新这些前瞻性声明。

INVESTOR CONTACT:

投资者联系:

Geoff O'Brien

杰夫•奥布莱恩

Vice President

副总统

MediciNova, Inc.

MediciNova公司。

info@medicinova.com

info@medicinova.com