Curacle Co., Ltd.

DUBLIN--( BUSINESS WIRE )--The "Diabetic Retinopathy - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering. This "Diabetic Retinopathy - Pipeline Insight, 2022" report provides comprehensive insights about 60+ companies and 60+ pipeline drugs in Diabetic Retinopathy pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage Diabetic Retinopathy Understanding Diabetic Retinopathy: Overview Diabetic Retinopathy Emerging Drugs Chapters This segment of the Diabetic Retinopathy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Diabetic Retinopathy Emerging Drugs KSI-301: Kodiak Sciences The Therapeutic candidate KSI-301, currently in clinical development, is a novel anti-VEGF biologic designed to have an extended ocular half-life. Ischemia due to vein occlusion results in secretion of vascular endothelial growth factor (VEGF) that causes further vascular leakage and edema. Anti-VEGF agents have become a very common treatment to improve the clinical outcomes in patients with diabetic retinopathy. As in wet AMD, an intensive treatment frequency is required to achieve optimal outcomes with currently-approved anti-VEGFs agents. However, many patients are lost to follow up due to the frequent injections and real-world outcomes in diabetic retinopathy do not meet the promise shown in clinical trials. By extending on mechanism treatment interval, KSI-301 may relieve the high treatment burden for patients, their family members, and physicians. KSI-301 is being developed in Phase III stage of development towards a once every four to six-month treatment regimen - a possible gamechanger that may provide the opportunity for real prevention. Brolucizumab: Novartis Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) and the most clinically advanced, humanized single-chain antibody fragment to reach this stage of development. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions, resolve retinal edema and improve vision in patients with chorioretinal vascular diseases. Currently, it is in Phase III stage of development to treat Diabetic Retinopathy. RGX 314: Regenxbio Inc. RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV AAV8 vector containing a gene encoding for a monoclonal antibody fragment. The expressed protein is designed to neutralize vascular endothelial growth factor (VEGF) activity, modifying the pathway for formation of new leaky blood vessels and retinal fluid accumulation. The company is currently enrolling patients in ALTITUDETM, a Phase II trial for the treatment of diabetic retinopathy using suprachoroidal delivery of RGX-314. Diabetic Retinopathy: Therapeutic Assessment This segment of the report provides insights about the different Diabetic Retinopathy drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Diabetic Retinopathy There are approx. 60+ key companies which are developing the therapies for Diabetic Retinopathy. The companies which have their Diabetic Retinopathy drug candidates in the mid to advanced stage, i.e. Phase III include, Kodiak Sciences Phases The report covers around 60+ products under different phases of clinical development like Late-stage products (Phase III ) Mid-Stage products (Phase II) Early-stage products ( Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates ^- Route of Administration Diabetic Retinopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Oral Molecule Type Products have been categorized under various Molecule types such as Small molecules Peptide Antibiotics Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Diabetic Retinopathy: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Diabetic Retinopathy therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Diabetic Retinopathy drugs. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Diabetic Retinopathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Retinopathy. Diabetic Retinopathy Report Insights Diabetic Retinopathy Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Diabetic Retinopathy Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing Diabetic Retinopathy drugs? How many Diabetic Retinopathy drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Diabetic Retinopathy? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diabetic Retinopathy therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Diabetic Retinopathy and their status? What are the key designations that have been granted to the emerging drugs? Key Products KSI-301 Brolucizumab Runcaciguat RC 28 E AKB-9778 RG7774 RGX-314 APX3330 ADVM-022 THR-687 OCX 063 BI 764524 MS-553 A selection of companies mentioned in this report includes Ascentage Pharma AptaBio BONAC corporation CCRP Therapeutics Curacle Co Ltd Emerald Bioscience, Inc. EnnovaBio Everglades Biopharma LUYE PHARMA MIRAE CELL BIO Novelty Nobility Inc Noveome Biotherapeutics, Inc. Palatin Technologies Inc PharmAbcine Inc PYC Therapeutics Retinset SL RIBOMIC Shanghai Henlius Biotech OccuRx Kodiak Sciences Novartis Bayer RemeGen Aerpio Therapeutics Hoffman-La-Roche Regenxbio Inc. Ocuphire Pharma, Inc. Adverum Biotechnologies Oxurion MingSight Relin Pharmaceuticals Boehringer Ingelheim NovaGo Therapeutics HanAll Biopharma For more information about this clinical trials report visit https://www.researchandmarkets.com/r/vy3xvo About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

DUBLIN--( BUSINESS WIRE )--The "Diabetic Retinopathy - Pipeline Insight, 2022" report has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 60+ companies and 60+ pipeline drugs in Diabetic Retinopathy pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Diabetic Retinopathy Emerging Drugs Chapters This segment of the Diabetic Retinopathy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Diabetic Retinopathy Emerging Drugs KSI-301: Kodiak Sciences The Therapeutic candidate KSI-301, currently in clinical development, is a novel anti-VEGF biologic designed to have an extended ocular half-life. Ischemia due to vein occlusion results in secretion of vascular endothelial growth factor (VEGF) that causes further vascular leakage and edema. Anti-VEGF agents have become a very common treatment to improve the clinical outcomes in patients with diabetic retinopathy. As in wet AMD, an intensive treatment frequency is required to achieve optimal outcomes with currently-approved anti-VEGFs agents. However, many patients are lost to follow up due to the frequent injections and real-world outcomes in diabetic retinopathy do not meet the promise shown in clinical trials. By extending on mechanism treatment interval, KSI-301 may relieve the high treatment burden for patients, their family members, and physicians. KSI-301 is being developed in Phase III stage of development towards a once every four to six-month treatment regimen - a possible gamechanger that may provide the opportunity for real prevention. Brolucizumab: Novartis Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) and the most clinically advanced, humanized single-chain antibody fragment to reach this stage of development. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions, resolve retinal edema and improve vision in patients with chorioretinal vascular diseases. Currently, it is in Phase III stage of development to treat Diabetic Retinopathy. RGX 314: Regenxbio Inc. RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV AAV8 vector containing a gene encoding for a monoclonal antibody fragment. The expressed protein is designed to neutralize vascular endothelial growth factor (VEGF) activity, modifying the pathway for formation of new leaky blood vessels and retinal fluid accumulation. The company is currently enrolling patients in ALTITUDETM, a Phase II trial for the treatment of diabetic retinopathy using suprachoroidal delivery of RGX-314. Diabetic Retinopathy: Therapeutic Assessment This segment of the report provides insights about the different Diabetic Retinopathy drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Diabetic Retinopathy There are approx. 60+ key companies which are developing the therapies for Diabetic Retinopathy. The companies which have their Diabetic Retinopathy drug candidates in the mid to advanced stage, i.e. Phase III include, Kodiak Sciences Phases This report covers around 60+ products under different phases of clinical development like Late-stage products (Phase III ) Mid-Stage products (Phase II) Early-stage products ( Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Diabetic Retinopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Oral Molecule Type Products have been categorized under various Molecule types such as Small molecules Peptide Antibiotics Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Diabetic Retinopathy: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Diabetic Retinopathy therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Diabetic Retinopathy drugs. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Diabetic Retinopathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Retinopathy. Diabetic Retinopathy Report Insights Diabetic Retinopathy Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Diabetic Retinopathy Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing Diabetic Retinopathy drugs? How many Diabetic Retinopathy drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Diabetic Retinopathy? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diabetic Retinopathy therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Diabetic Retinopathy and their status? What are the key designations that have been granted to the emerging drugs? Key Players Kodiak Sciences Novartis Bayer RemeGen Aerpio Therapeutics Hoffman-La-Roche Regenxbio Inc. Ocuphire Pharma, Inc. Adverum Biotechnologies Oxurion MingSight Relin Pharmaceuticals Boehringer Ingelheim NovaGo Therapeutics HanAll Biopharma Ascentage Pharma AptaBio BONAC corporation CCRP Therapeutics Curacle Co Ltd Emerald Bioscience, Inc. EnnovaBio Everglades Biopharma LUYE PHARMA MIRAE CELL BIO Novelty Nobility Inc Noveome Biotherapeutics, Inc. Palatin Technologies Inc PharmAbcine Inc PYC Therapeutics Retinset SL RIBOMIC Shanghai Henlius Biotech OccuRx Key Products KSI-301 Brolucizumab Runcaciguat RC 28 E AKB-9778 RG7774 RGX-314 APX3330 ADVM-022 THR-687 OCX 063 BI 764524 MS-553 For more information about this report visit https://www.researchandmarkets.com/r/lg24xg

Technology licensing and collaboration agreement signed with Théa, the leading independent European ophthalmology company, for a ‘diabetic macular edema and wet-AMD treatment’ drug candidate. Up to $2 billion in total payments, including upfront payment, payments for development and regulatory milestones, and royalties anticipated to be paid. Technology transfer and collaboration targeting all countries of the world except Asia. SEOUL, South Korea--(BUSINESS WIRE)-- CURACLE, a Korea-based biopharmaceutical company, today announced that it has entered into an exclusive license and collaboration agreement with Théa Open Innovation, the sister company of Théa, Europe’s number one independent ophthalmic company with a 150-year history, for the development and commercialization of CURACLE’s CU06-RE, that has the potential to become the first orally administered treatment for diabetic macular edema and wet age-related macular degeneration (wet-AMD). Under the terms of the agreement, CURACLE will receive an upfront payment of $6 million and could receive up to an additional $157.5 million in potential development, regulatory and sales milestones, as well as royalties on sales if CU06-RE is successfully developed, which will entitle CURACLE to receive up to $2 billion in total payments. Théa and CURACLE will closely collaborate on the clinical development of this novel oral drug. CURACLE will be responsible for the Phase I and II clinical studies with TOI providing both financial and infrastructure support. Further, under the terms of the agreement, CURACLE will retain the marketing rights in all Asia countries while Théa will have the marketing rights in all other countries around the world. According to Dr. Young Guen Kwon, the founder of CURACLE, “CU06-RE is expected to be the world’s first `orally administered' treatment for diabetic macular edema and wet-AMD, and because of its high efficacy and convenience as an oral treatment, CU06-RE promises to establish the standard for treatment that reduces the number of intraocular injection (IVT) administration made possible through co-administration with anti-VEGF.” Dr. Kwon added that “As the world’s first vascular endothelial dysfunction blocker developed with CURACLE’s SOLVADYS platform technology, CU06-RE can be applied to patients whose symptoms have worsened due to resistance to anti-VEGF injections, providing great hope for patients who currently do not have a suitable treatment option.” ”Through this strategic and collaborative alliance with Théa, a leading global ophthalmic company, we have been able to accelerate the development of CU06-RE as the world’s first oral treatment and the world’s first vascular endothelial dysfunction blocker,” said Jae Hyeon Ryu, the CEO of CURACLE. "We look forward to providing innovative treatments faster to the millions of patients with diabetic macular edema and wet-AMD around the world who are suffering without an appropriate treatment option,” added Mr. Ryu. “We are excited about partnering with CURACLE, a truly innovative biotechnology company with a game changing technology platform,” remarked Mr. Jean-Frédéric Chibret, president of Théa. Mr. Chibret further commented that “through this licensing collaboration, Théa and CURACLE will provide a new first-in-class treatment with an alternative and non-invasive route of administration and most importantly, convenience for patients. This agreement is in line with the other partnerships that we have set up over the last two years and further illustrates our will to build a strong and diversified retina pipeline.” About CURACLE CURACLE (KOSDAQ) is a Korea-based clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapeutics for the treatment of aged-related vascular and intractable metabolic diseases and cancers. Founded in 2016, CURACLE has developed the disease-expressive screening system, SOLVADYS Platform, which screens substances that directly convert the pathological characteristics of the capillary vessels such as leakage, inflammatory activation, and apoptosis using human organ-specific primary endothelial cells. The SOLVADYS Platform dramatically improves the efficacy and ease of administration for acute and chronic conditions that are accompanied by vascular leakage, inflammation and loss of endothelial cells. For more information visit: About Théa and Théa Open Innovation Théa is a leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, this family-owned company has continued to expand by opening more than 30 affiliates and offices in Europe, Russia, North Africa, North and South America. Its products are available in 75 countries. Théa Open Innovation (TOI) is a sister company of Théa. TOI's mission is to set up partnerships with companies and universities to help bring the most innovative products in ophthalmology to the market. For more information visit: