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Medicinova Granted Notice of Allowance for New patents in NASH, NAFLD and ALS

01 Nov Medicinova Granted Notice of Allowance for New patents in NASH, NAFLD and ALS

Medicinova (NASDAQ: MNOV), a Company developing small molecule therapeutics, has received notice of allowances for grant of new patents for MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS) from the Canadian Intellectual Property Office, in addition to receiving a Notice of Allowance for MN-001 (tipelukast) for the treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) from the Japan Patent Office.

Medicinova (NASDAQ: MNOV)

Market Cap: $353.37M; Current Share Price: 8.06 USDChart
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Once the patent is issued, the claim will afford protection for the Company until December 2028 and 2032 respectively. It also covers treatment, oral administration including tablets and capsules and liquid dosage forms.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc stated,

“We are very pleased to receive notice that this new patent will be granted as we believe it could substantially increase the potential value of MN-166. Previously, the U.S. FDA granted both orphan-drug designation and fast-track designation and the European Commission granted Orphan Medicinal Product Designation to MN-166 for the treatment of ALS.”

MN-166 (ibudilast), a small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor, can inhibit pro-inflammatory cytokines and promotes neurotrophic factors. In preclinical and clinical studies, the drug has demonstrated the ability to offer anti-neuroinflammatory and neuroprotective actions, which is useful in treating a wide range of conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), substance abuse/addiction and glioblastoma (GBM).

MN-001 (tipelukast), on the other hand, is a small molecule possessing anti-inflammatory and anti-fibrotic activity including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). This mechanism of inhibiting the 5-LO/LT pathway is deemed a novel approach to treating fibrosis.

Amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease is a progressive neurodegenerative disease, characterized by the atrophy of nerve cells in brain and spinal cord, leading to hardening and scarring in the affected region. As the disease progresses, patients gradually lose the functioning of muscles, including those that control speech, movement and breathing. The disease manifests in two forms, sporadic and familial, with 90 to 95 percent of all cases in the U.S being Sporadic. Familial or the inherited form of the disease constitutes the other 5 to 10 percent.

According to information made available by the ALS association, there are over 16,500 Americans afflicted with ALS and nearly 5000 new cases are diagnosed each year. The life expectancy after diagnosis is merely 2 to 5 years, with an estimated $250,000 being spent on out-of-pocket treatment costs. The Global ALS treatment market is expected to be worth over USD 3.6 billion by 2026, growing at a CAGR of 21.6 percent, from USD 0.75 billion in 2018, according to a report by Data Bridge Market Research.

Image Source: ALS.org

Nonalcoholic Steatohepatitis (NASH) is a form of Non-Alcoholic Fatty Liver Disease (NAFLD) and is characterized by the buildup of FAT in the liver. This condition is marked by hepatitis, inflammation, cell damage and fat deposits in the liver. These fat deposits can cause fibrosis of the liver, in turn leading to liver cancer or cirrhosis.

According to an estimate only 20 percent of the people suffering from NAFLD have NASH, while the rest only have a simple fatty liver. While nearly 40 percent in the U.S are afflicted with NAFLD, around 3 to 4 percent have NASH. The American Liver foundation estimates that over 100 million people suffer from NAFLD in the U.S alone.

Though the exact cause of the disease is still unknown, NASH often develops from underlying conditions such as obesity and type 2 diabetes, and can affect people of any age. Individuals who have insulin resistance, high triglyceride levels or abnormal cholesterol levels, hypertension and uncontrolled blood glucose are at an increased risk of developing this condition. NASH also increases the chances of developing cardio vascular anomalies and can lead to death from liver-related causes. Currently there are no approved therapies for this condition, with treatment limited to alleviating the symptoms of the condition.

According to a report by Reports and Data, the Global NASH market will be worth over USD 13.38 Billion by 2026.

MediciNova’s therapeutic focus is on developing novel small molecules for the treatment of neurological, respiratory and fibrotic diseases. To this end, the Company is pursuing strategic alliances with North American, European and Japanese pharmaceutical companies to develop a diverse yet robust pipeline of candidates that have a strong patent portfolio and commercial potential.

The Company’s pipeline consists of candidates for the treatment of acute exacerbations of asthma and COPD, progressive multiple sclerosis, methamphetamine addiction, neuropathic pain, asthma, interstitial cystitis, and solid tumor cancers. MN-001, its lead candidate for the treatment of ALS, was licensed from Kyorin Pharmaceutical Co., Ltd. (Tokyo) in 2002. Additionally, the Company licensed the MN-029 from Angiogene Pharmaceuticals Ltd. (Oxford, UK) the same year. MediciNova also acquired MN-221 from Kissei Pharmaceutical Co., Ltd. (Matsumoto City, Japan), MN-305 and MN-246 from Mitsubishi Pharma Corp. (Osaka) and MN-166 from Kyorin Pharmaceutical Co., Ltd. (Tokyo) in 2004.

Image Source: Company

The Company is engaged in developing MN-001 for liver fibrosis (NASH and others) and Pulmonary Fibrosis. In the area of neurological diseases, its target is progressive multiple sclerosis, ALS and Methamphetamine addiction. In addition, it is also trying to address the unmet need in acute exacerbations of asthma through MN-221.

MediciNova has research collaboration with National Cerebral and Cardiovascular disease Research Centre in Japan for the development of MN-001. The Company has a strong intellectual property rights portfolio, with extensive protection for its candidates under clinical development.

Risk Assessment

  • The ALS market is expected to present a 3.6 billion opportunity by 2026, while the NASH and NAFLD will be worth over USD 13.38 Billion by 2026. If the Company continues to make positive progress with its clinical trials, it has the potential to establish itself in these markets with a large unmet medical need.
  • The Company has strategic commercial and research partnerships with organizations in Japan, North America and Europe. This will help the Company navigate the regulatory hurdles posed by business in these markets as well as use their technical and operational expertise.
  • MediciNova is making a concerted effort to establish a strong intellectual property portfolio for the candidates in its pipeline, this will not only help the Company protect its technology but also enhance its commercial prospects.
  • Clinical trials are risky and their outcome is unpredictable. However the Company has a diverse pipeline of candidates, which will help it mitigate the risks associated with any adverse setbacks in its clinical trials.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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