A NASH Drug Candidate ASC42 Received Fast Track Designation

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Author:华讯知识产权
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Time of issue:2020-12-18 10:50
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(Summary description)A NASH Drug Candidate ASC42 Received Fast Track Designation A non-alcoholic steatohepatitis (NASH) drug candidate ASC42, an Farnesoid X Receptor (FXR) Agonist from Gannex received Fast Track designation from the U.S. Food and Drug Administration (FDA) on 14 December 2020. The U.S. FDA’s Fast track is a process designed to facilitate new drug development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need; and its purpose is to get important new drugs to the patient earlier. This Fast Track designation represents FDA’s recognition of ASC42’s potential in addressing these unmet medical needs for NASH patients. Gannex is a wholly owned company of Ascletis Pharma Inc. and fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex received the investigational new drug application (IND) approval for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed, novel non-steroidal, selective, potent FXR agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis. The oral tablet formulation of ASC42 has been developed with the in-house proprietary technology and is stable at room temperature. NASH is a progressive liver disease caused by excessive accumulation of fat in the liver. It can cause chronic inflammation in the liver, trigger progressive liver fibrosis, cirrhosis, and ultimately lead to liver failure, cancer and patient death. The liver-related mortality in patients with advanced fibrosis is significantly increased. However, there are no FDA approved medicines for NASH indication yet. At present, NASH is predicted to be one of the largest drug markets in the field of drug treatment for liver diseases after hepatitis C. It is estimated that the global NASH therapeutic drug market will reach US$40 billion in 2025. In addition to Gannex’s ASC42, Potential drugs with rapid progress in clinical research include e.g., GENFIT's PPAR receptor agonist Elafibranor, Intercept's farnesol receptor (FXR) agonist obeticholic acid (OCA), Allergan's CCR2/CCR5 chemokine receptor blocker Cenicriviroc (CVC), Gilead's anti-apoptotic signal-regulating kinase 1 (ASK1) inhibitor Selonsertib, and Inventiva’s pan-PPAR agonist Lanifibranor.

A NASH Drug Candidate ASC42 Received Fast Track Designation

(Summary description)A NASH Drug Candidate ASC42 Received Fast Track Designation

A non-alcoholic steatohepatitis (NASH) drug candidate ASC42, an Farnesoid X Receptor (FXR) Agonist from Gannex received Fast Track designation from the U.S. Food and Drug Administration (FDA) on 14 December 2020.

The U.S. FDA’s Fast track is a process designed to facilitate new drug development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need; and its purpose is to get important new drugs to the patient earlier. This Fast Track designation represents FDA’s recognition of ASC42’s potential in addressing these unmet medical needs for NASH patients.

Gannex is a wholly owned company of Ascletis Pharma Inc. and fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex received the investigational new drug application (IND) approval for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed, novel non-steroidal, selective, potent FXR agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis. The oral tablet formulation of ASC42 has been developed with the in-house proprietary technology and is stable at room temperature.

NASH is a progressive liver disease caused by excessive accumulation of fat in the liver. It can cause chronic inflammation in the liver, trigger progressive liver fibrosis, cirrhosis, and ultimately lead to liver failure, cancer and patient death. The liver-related mortality in patients with advanced fibrosis is significantly increased. However, there are no FDA approved medicines for NASH indication yet.

At present, NASH is predicted to be one of the largest drug markets in the field of drug treatment for liver diseases after hepatitis C. It is estimated that the global NASH therapeutic drug market will reach US$40 billion in 2025. In addition to Gannex’s ASC42, Potential drugs with rapid progress in clinical research include e.g., GENFIT's PPAR receptor agonist Elafibranor, Intercept's farnesol receptor (FXR) agonist obeticholic acid (OCA), Allergan's CCR2/CCR5 chemokine receptor blocker Cenicriviroc (CVC), Gilead's anti-apoptotic signal-regulating kinase 1 (ASK1) inhibitor Selonsertib, and Inventiva’s pan-PPAR agonist Lanifibranor.

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-12-18 10:50
Views:

Information

A NASH Drug Candidate ASC42 Received Fast Track Designation

A non-alcoholic steatohepatitis (NASH) drug candidate ASC42, an Farnesoid X Receptor (FXR) Agonist from Gannex received Fast Track designation from the U.S. Food and Drug Administration (FDA) on 14 December 2020.

The U.S. FDA’s Fast track is a process designed to facilitate new drug development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need; and its purpose is to get important new drugs to the patient earlier. This Fast Track designation represents FDA’s recognition of ASC42’s potential in addressing these unmet medical needs for NASH patients.

Gannex is a wholly owned company of Ascletis Pharma Inc. and fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex received the investigational new drug application (IND) approval for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed, novel non-steroidal, selective, potent FXR agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis. The oral tablet formulation of ASC42 has been developed with the in-house proprietary technology and is stable at room temperature.

NASH is a progressive liver disease caused by excessive accumulation of fat in the liver. It can cause chronic inflammation in the liver, trigger progressive liver fibrosis, cirrhosis, and ultimately lead to liver failure, cancer and patient death. The liver-related mortality in patients with advanced fibrosis is significantly increased. However, there are no FDA approved medicines for NASH indication yet.

At present, NASH is predicted to be one of the largest drug markets in the field of drug treatment for liver diseases after hepatitis C. It is estimated that the global NASH therapeutic drug market will reach US$40 billion in 2025. In addition to Gannex’s ASC42, Potential drugs with rapid progress in clinical research include e.g., GENFIT's PPAR receptor agonist Elafibranor, Intercept's farnesol receptor (FXR) agonist obeticholic acid (OCA), Allergan's CCR2/CCR5 chemokine receptor blocker Cenicriviroc (CVC), Gilead's anti-apoptotic signal-regulating kinase 1 (ASK1) inhibitor Selonsertib, and Inventiva’s pan-PPAR agonist Lanifibranor.

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Electronic Arts pledges free use for five accessibility patents

Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The

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