Tag: Inflammatory
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Oculis Strengthens Leading Ophthalmology Pipeline by In-Licensing Neuroprotective Drug Candidate for Glaucoma from Accure Therapeutics
ACT-01, which is being renamed OCS-05, is a first-in-class small molecule with neuroprotective activity that has shown positive results in animal models of neuroinflammation and neurodegeneration. Its mechanism of action is related to the activation of the trophic factor pathways such as IGF-1 and BDNF. In ophthalmology, this action can protect the nerve axons in conditions where the optic nerve is affected, such as in acute optic neuritis and glaucoma, where the OCS-05 could prevent chronic vision loss.
Based on positive preclinical data and results of a phase 1 safety and PK study in healthy volunteers, a phase 2a study was initiated (the ACUITY study).
ACUITY is a two-arm, randomized, double-blind, placebo-controlled, monocentric study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis. In addition to safety, secondary outcome measures will include optic nerve anatomical measures, as well as visual function measures. The study is ongoing at the La Pitie-Salpetriere hospital in Paris within the neurology-ophthalmology network of the Public University Hospital Group in Paris (APHP). One third of the planned sample size has been enrolled.
Oculis is currently planning the expansion of the program in ophthalmology working with the regulatory agencies in the US, EU and China amongst others.
Riad Sherif, M.D., CEO of Oculis, said: "We are excited about this agreement as it combines Oculis's ophthalmology expertise with Accure's unique neuroprotective approach to help transform the treatment of neurodegenerative diseases in ophthalmology. At Oculis, our focus is on building a highly innovative and differentiated pipeline providing life changing treatments for ocular unmet medical needs, and OCS-05 is a perfect fit for that ambition. Glaucoma is a leading global cause of irreversible blindness, and despite IOP lowering treatments, a significant proportion of patients still go blind. With OCS-05, we have the potential to bring to market the first neuroprotective for glaucoma and other optic neuropathies."
Laurent Nguyen, M.D., Co-founder and Chief Executive Officer at Accure Therapeutics, said: "Having shown promising early data and potential in a number of ocular disease indications, the timing is right for a partnership between two like-minded companies committed to patients and driven by a passion for neuroscience. By leveraging its expertise in ophthalmology, Oculis has the potential to fulfill the promise of this exciting asset in a wide range of neurodegenerative diseases."
In reference experimental animal models of acute optic neuritis (acute inflammatory demyelinating disorder of the optic nerve) and high-pressure glaucoma (high eye pressure damaging the optic nerve and leading to permanent vision loss), OCS-05 reduces damage to the optic nerve and retina. It also decreases paralysis progression in an autoimmune encephalomyelitis animal model for multiple sclerosis (inflammation caused by the body's immune system, which destroys nerve cell processes and myelin in the brain and spinal cord).
Data from a completed phase 1 study show the safety and tolerability of single and multiple doses of OCS-05 in healthy volunteers.
Under the terms of the agreement, Accure Therapeutics will receive an upfront payment, potential milestone payments upon the achievement of certain development and commercial milestones, and tiered royalties on sales.
Anthony Rosenberg, Chairman of Oculis's Board of Directors, said: "The addition of OCS-05 to Oculis's pipeline is very much in line with the Company's strategy to develop transformative therapies that address the root cause of ocular disease to improve patients' sight and quality of life. There is a clear need for first-in-class therapies that can protect and prevent damage to the optic nerve and retina. Oculis has the team and expertise to bring OCS-05 through clinical trials and ultimately to patients around the world."
Montserrat Vendrell, Chairman of Accure Therapeutics and Partner at Alta Life Sciences added: "This licensing deal with Oculis is a proof-of-concept of the value creation that Accure Therapeutics brings as a translational R&D engine, taking forward truly unique science that spun-off from the University of Barcelona. This licensing agreement will enhance Accure's capabilities to accelerate and expand value potential for the rest of its pipeline."
About Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide.
Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
About Accure Therapeutics
Accure Therapeutics is a private translational neuroscience R&D company. Based in Barcelona (Spain), it was launched in 2020 with a Series A funding led by Alta Life Sciences Spain I and supported by the Centre for Technological and Industrial Development (CDTI). This European company with an international mindset boasts a unique portfolio of three new chemical entity programs pursuing innovative targets - with potential to accommodate others. Accure aims to develop new disease modifying drugs to treat serious conditions such as optic neuritis, multiple sclerosis, Parkinson's disease and epilepsy. With an experienced business and scientific team, Accure Therapeutics is one of the few companies that operate in an agnostic fashion on initial science to deliver cutting-edge drugs in CNS.
To learn more visit https://accure.health/
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comOculis S.A., (Oculis) a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, and Accure Therapeutics, a private translational neuroscience R&D company
IND Application for SinoMab’s First-in-Class Asthma Therapeutic Product SM17 Accepted by FDA
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SM17 is the world's first monoclonal antibodies targeting IL17BR co-developed by SinoMab and LifeArc (a medical research charity based in the United Kingdom). SM17 has a wide range of indications, including indications with large market volumes such as asthma and diseases with high mortality rates such as idiopathic pulmonary fibrosis. Comparing to other products on the market, SM17 enjoys differentiation advantages. With the preclinical data and unique mechanism of action of SM17, Company believes that SM17 potentially has a broader and more beneficial effect on asthma treatment than other approved biologics.
In the global market, the number of asthma patients is gradually increasing and is expected to reach 247.5 million by 2023 and further increase to 267.7 million by 2030. The number of asthma patients in the PRC is increasing at a greater pace than the global rate and is forecasted to reach 25.6 million by 2023 and further increase to 27.8 million by 2030. In terms of market size, the global asthma market is projected to reach US$25.1 billion by 2023 and US$34.6 billion by 2030. However, the asthma market in the PRC is expected to reach RMB36.4 billion by 2023 and RMB65.0 billion by 2030. In terms of treatment options, traditional asthma treatment is based on inhaled corticosteroid, but they are prone to serious adverse effects, especially in adolescents. Drug resistance can also develop if used for a long time. The introduction of SM17 is expected to provide a better treatment option in terms of the balance of efficacy and safety.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "following the acceptance of the IND application for SN1011 for the treatment of multiple sclerosis by the NMPA, the acceptance of the SM17 IND application by the FDA fully demonstrates the efficient execution of the Company's new drug R&D program. There is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. We are therefore confident in the enormous prospects of SM17's clinical development. Our core products, including SM03, SN1011 and SM17, is making progress on the clinical R&D smoothly, driving the Company moving steadily towards commercialization. In the future, we will accelerate our projects implementation to bring benefits to patients and create value for shareholders through innovation."
About SM17
SM17 is known to be the world's first humanized, IgG4-k monoclonal antibody for new drug development, which targets IL-17RB. And IL-17RB is a type-I single transmembrane glycoprotein belonging to IL-17 receptor family. The binding of SM17 to IL-17RB could suppress Th2 immune responses induced by a category of cytokines called "alarmin", which has shown to be implicated in the pathogenesis of allergic disease and airway viral responses. Alternative approach targeting upstream mediators of the Th2 inflammatory cascade, such as "alarmins", is expected to have a broader effect on airway inflammation and to provide more effective asthma control than currently available therapies, and products with similar mechanism of action as SM17 have been approved by FDA.
About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases
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