MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Treatment of Chlorine-Induced Acute Respiratory Distress Syndrome
MediciNova announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering MN-166 (ibudilast) for treating chlorine-induced acute respiratory distress syndrome (ARDS). This patent, expected to expire no earlier than January 2042, includes claims for MN-166 as a monotherapy or in combination with other drugs, and covers various administration methods and dosing frequencies. The announcement follows a promising nonclinical model study showing significant improvements in pulmonary function and survival rates with MN-166. Chief Medical Officer Kazuko Matsuda expressed optimism about the potential value this patent adds to MN-166.
- Notice of Allowance received from the U.S. Patent and Trademark Office.
- Patent covers MN-166 (ibudilast) for treating chlorine-induced ARDS.
- Patent expected to expire no earlier than January 2042.
- Claims include monotherapy and combination therapy with other drugs.
- Patent covers various administration methods, including oral, intravenous, and inhalation.
- Patent includes a wide range of doses and treatment periods.
- Nonclinical model study showed significant improvement in pulmonary function and higher survival rates.
- The PR did not mention any immediate financial gains or partnerships resulting from the patent.
- The efficacy of MN-166 is currently based on nonclinical model studies, not clinical trials.
- Potential delays in bringing MN-166 to market due to the need for further clinical testing and regulatory approvals.
Insights
The Notice of Allowance for MediciNova's patent on MN-166 (ibudilast) for the treatment of chlorine-induced ARDS is notably significant. Acute Respiratory Distress Syndrome (ARDS) is a severe condition characterized by sudden respiratory failure due to fluid buildup in the lungs, which can be fatal. Chlorine-induced ARDS is of particular concern due to its potential use in chemical exposure scenarios or industrial accidents.
This patent could be a game-changer for MediciNova. The broad coverage of administration methods (oral, intravenous, subcutaneous, intramuscular and inhalation) and dosing regimens significantly enhances the therapeutic flexibility and commercial potential of MN-166. Furthermore, the patent's protection lasting until January 2042 provides a long runway for the company to capitalize on this innovation.
However, it's important to note that this patent is still in its early stages. While nonclinical models have demonstrated promising results, human clinical trials are necessary to confirm the medication's efficacy and safety for this specific use. Investors should consider the typical high-risk, high-reward nature of biopharmaceutical investments, where early promising results may not always translate into successful marketable therapies.
The issuance of a Notice of Allowance for a patent involving MN-166 (ibudilast) represents a strategic asset for MediciNova. Patents are critical in the pharmaceutical industry as they protect proprietary drugs from generic competition, potentially allowing the company to set premium pricing and secure market share. Given the patent extends to January 2042, MediciNova has a substantial period to navigate clinical trials, regulatory approvals and potentially bring the product to market without immediate competitive threats.
From a market perspective, ARDS is a condition with significant unmet medical needs, particularly in cases of chemical exposure like chlorine. The flexibility in administration methods and dosing regimens could make MN-166 an attractive option for both healthcare providers and patients. However, the market potential will largely depend on future clinical trial outcomes and the ability to demonstrate clear advantages over existing treatments.
Another consideration for investors is the broader applicability of MN-166. Although the current patent focuses on chlorine-induced ARDS, MN-166 has potential utility in other indications, which could diversify revenue streams and mitigate single-market dependency risks.
LA JOLLA, Calif., May 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), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of chlorine-induced acute respiratory distress syndrome (ARDS).
Once issued, this patent is expected to expire no earlier than January 2042. The allowed claims cover the use of MN-166 (ibudilast) for treating chlorine-induced ARDS. The allowed claims cover the use of MN-166 (ibudilast) as a monotherapy or as a combination therapy with one or more other drugs. The allowed claims cover oral administration, intravenous administration, subcutaneous injection, intramuscular injection, and inhalation administration. The allowed claims cover a wide range of doses of MN-166 (ibudilast), a range of different dosing frequencies, and a range of different treatment periods.
Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased to receive notice of this new patent allowance and we believe it could increase the potential value of MN-166. The potential efficacy of MN-166 for the treatment of chlorine-induced ARDS was recently demonstrated in a nonclinical model study of chlorine-induced lung damage in which MN-166 demonstrated a large and significant improvement in pulmonary function and a higher survival rate.”
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 is also in development for glioblastoma, Long COVID, 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 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
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