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MediciNova Receives Notice of Allowance from United States Patent and Trademark Office for New Patent Covering MN-001 for Triglyceride Synthesis in the Liver

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MediciNova (NASDAQ:MNOV) has received a Notice of Allowance from the USPTO for a new patent covering MN-001 (Tipelukast) for decreasing triglyceride synthesis in the liver. The patent application covers a method of administering MN-001 or its metabolite to subjects with insulin resistance, pre-diabetes, or diabetes. The patent, expected to expire no earlier than May 26, 2042, includes claims for various formulations and administration methods. The compound can be administered orally with flexible dosing frequencies.

MediciNova (NASDAQ:MNOV) ha ricevuto un Avviso di Concessione dall'USPTO per un nuovo brevetto che copre MN-001 (Tipelukast) per ridurre la sintesi dei trigliceridi nel fegato. La domanda di brevetto riguarda un metodo di somministrazione di MN-001 o del suo metabolita a soggetti con resistenza all'insulina, pre-diabete o diabete. Il brevetto, la cui scadenza è prevista non prima del 26 maggio 2042, include rivendicazioni per varie formulazioni e metodi di somministrazione. Il composto può essere somministrato oralmente con frequenze di dosaggio flessibili.

MediciNova (NASDAQ:MNOV) ha recibido un Aviso de Concesión de la USPTO para una nueva patente que cubre MN-001 (Tipelukast) para disminuir la síntesis de triglicéridos en el hígado. La solicitud de patente abarca un método de administración de MN-001 o su metabolito a sujetos con resistencia a la insulina, prediabetes o diabetes. La patente, que se espera que expire a más tardar el 26 de mayo de 2042, incluye reivindicaciones para varias formulaciones y métodos de administración. El compuesto puede administrarse por vía oral con frecuencias de dosificación flexibles.

MediciNova (NASDAQ:MNOV)는 간에서 트리글리세리드 합성을 감소시키기 위한 MN-001(티펠루카스트)에 대한 새로운 특허에 대해 USPTO로부터 허가 통지를 받았습니다. 특허 출원은 인슐린 저항성, 전당뇨병 또는 당뇨병 환자에게 MN-001 또는 그 대사산물을 투여하는 방법을 다룹니다. 2042년 5월 26일 이전에 만료될 것으로 예상되는 이 특허에는 다양한 제형 및 투여 방법에 대한 청구 항목이 포함되어 있습니다. 이 화합물은 유연한 용량 주기로 구강 투여가 가능합니다.

MediciNova (NASDAQ:MNOV) a reçu un Avis de Concession de l'USPTO pour un nouveau brevet couvrant MN-001 (Tipelukast) en vue de diminuer la synthèse des triglycérides dans le foie. La demande de brevet porte sur un moyen d'administrer MN-001 ou son métabolite à des sujets présentant une résistance à l'insuline, un pré-diabète ou un diabète. Le brevet, dont l'expiration est prévue au plus tôt le 26 mai 2042, comprend des revendications pour diverses formulations et méthodes d'administration. Le composé peut être administré par voie orale avec des fréquences de dosage flexibles.

MediciNova (NASDAQ:MNOV) hat von der USPTO eine Zulassungsmitteilung für ein neues Patent erhalten, das MN-001 (Tipelukast) zur Verringerung der Triglyceridsynthese in der Leber abdeckt. Die Patentanmeldung umfasst ein Verfahren zur Verabreichung von MN-001 oder seinem Metaboliten an Personen mit Insulinresistenz, Prädiabetes oder Diabetes. Das Patent, dessen Ablauf nicht vor dem 26. Mai 2042 erwartet wird, umfasst Ansprüche auf verschiedene Formulierungen und Verabreichungsmethoden. Die Verbindung kann oral mit flexiblen Dosierungsfrequenzen verabreicht werden.

Positive
  • Patent protection secured until 2042 for MN-001's liver triglyceride synthesis method
  • Expanded intellectual property portfolio strengthening market position
  • Patent covers multiple administration methods and dosing flexibility
Negative
  • None.

Insights

The patent allowance for MN-001 (Tipelukast) represents a significant intellectual property milestone for MediciNova in the metabolic disease space. The patent's coverage until 2042 provides substantial market exclusivity for treating liver triglyceride synthesis, particularly in patients with insulin resistance and diabetes. This therapeutic approach addresses a critical medical need, as elevated liver triglycerides are closely linked to metabolic disorders affecting millions globally.

The broad claims covering various formulations and administration routes enhance the commercial potential. However, it's important to note that this is primarily an IP development - while valuable for protecting future revenue streams, significant clinical development work remains before commercialization. The patent strengthens MediciNova's competitive position but doesn't guarantee market success.

LA JOLLA, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a pending patent application for MN-001 (Tipelukast) to cover "Method to Decrease Triglyceride Synthesis in a Liver of a Subject." The allowed claims cover a groundbreaking method for decreasing triglyceride synthesis in the liver by administering MN-001 (Tipelukast) or its metabolite or pharmaceutically acceptable salt. This method is particularly beneficial for subjects diagnosed with insulin resistance, pre-diabetes, or diabetes. Once issued, this patent is expected to expire no earlier than May 26, 2042.

Key Claims of the Patent Include:

  • Method:Method to Decrease Triglyceride Synthesis in the liver;
  • Formulations: MN-001 (Tipelukast) can be administered in various forms;
  • Administration: The compound can be administered orally, in various formulations; and
  • Dosage Flexibility: The compound can be administered in a range of different dosing frequencies.

Kazuko Matsuda, M.D., Ph.D., M.P.H., MediciNova’s Chief Medical Officer commented, ” We are excited to receive this Notice of Allowance, which underscores our commitment to developing innovative and proprietary treatments for metabolic disorders. This patent represents a significant advancement in our efforts to provide safe and effective therapies for patients with insulin resistance, pre-diabetes, and diabetes.”

The Notice of Allowance is a critical step towards the issuance of the patent, which will provide MediciNova with intellectual property protection for this novel method of treatment. This achievement highlights the company's dedication to advancing medical science and improving patient outcomes.

About 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 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, MN-001 was found to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake.

About NAFLD, Type 2 Diabetes Mellitus (T2DM), and Hypertriglyceridemia

NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD. There is sufficient clinical and epidemiological evidence supporting the assertion that NAFLD is strongly associated with an increased prevalence and incidence of cardiovascular disease, T2DM, chronic kidney disease, and malignancy. The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20 - 80% of NAFLD cases.

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 Long COVID 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, 2023 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:

David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com


FAQ

When will MediciNova's new patent for MN-001 (MNOV) expire?

The patent is expected to expire no earlier than May 26, 2042.

What conditions does MediciNova's new MN-001 patent (MNOV) target?

The patent covers treatment for subjects with insulin resistance, pre-diabetes, and diabetes by decreasing triglyceride synthesis in the liver.

How is MN-001 administered according to MediciNova's new patent (MNOV)?

MN-001 can be administered orally in various formulations with flexible dosing frequencies.

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