NIHR Manchester Biomedical Research Centre

BOSTON--( BUSINESS WIRE )-- DeepCure , a therapeutics company using AI to discover novel drugs for inflammation and immune diseases, today announced the selection of its first development candidate, DC-9476. DC-9476 is a third generation BRD inhibitor that is selective for the BD2 domain of Brd4, which is expected to enter clinical trials in 2025. The BD2 domain of Brd4 regulates multiple, clinically validated, cytokine-related pathways, such as TNF-alpha, IL6, IL-17, and IL-1b, that are important in a variety of autoimmune diseases. Many autoimmune diseases have epigenetic changes, including histone modifications that alter chromatin structure and gene expression. The BET family of proteins, which includes Brd4, that “read” these histone modification can cause patterns of gene expression in innate and adaptive immune cells that persist long after the stimulus is gone. In addition, Brd4 BD2 activity can also directly regulate transcription factors. Inhibition of Brd4 BD2 by small molecule drugs can break a self-perpetuating cycle of gene expression that can occur across multiple pathways that is detrimental to normal tissues and reinstate self-resolving processes that should follow inflammatory triggers. DC-9476 has shown promising efficacy in multiple preclinical models of autoimmune diseases, including rheumatoid arthritis (RA) and Still’s disease. In RA models, DC-9476 was superior to standard of care therapies, TNF-alpha inhibitors, IL-6 inhibitors, and the JAK inhibitor tofacitinib, and it also improved the effectiveness of TNF-alpha inhibitors when used in combination therapy. Unlike earlier generations of non-selective inhibitors, DC-9476 has an excellent safety profile and did not cause thrombocytopenia. The novel candidate was discovered using DeepCure’s proprietary AI platform by exploiting differences in the structure and function among the BET protein family and the two bromodomains (BD1 and BD2). DeepCure’s AI platform integrates advanced ML and physics-based tools to find interaction sites on the protein surface (PocketExpander™) and to design novel, diverse compounds that are synthetically feasible (MolGen™). “In the past years of translational and clinical research we have learnt that autoimmune diseases are the effect of multiple deranged pathways. Targeted therapies against specific cytokines, kinases or receptors have offered a first important boost in how we manage these conditions but patients would benefit enormously from pharmacological inhibition of multiple inflammatory pathways,” said Professor Francesco Del Galdo, M.D., Ph.D., Professor of Experimental Medicine NIHR Biomedical Research Centre and Institute of Rheumatic and Musculoskeletal Medicine University of Leeds. “However, current attempts with simply combining clinically existing therapies that target individual pathways have shown limited success, mostly due to increased toxicity. New therapeutics such as DC-9476 that have a novel mechanism to address simultaneously multiple pathways while also having an excellent safety profile, are extremely promising for the field.” “We’re excited to announce our first AI-generated candidate, which we plan to advance into clinical trials next year. This validates our generative AI and physics-based drug discovery engine,” said Kfir Schreiber, CEO & Co-Founder, DeepCure. “DC-9476 is the first of many novel development candidates to emerge from our platform, with the potential to transform the treatment of inflammation and immune diseases.” About DeepCure DeepCure was founded by researchers at MIT to accelerate breakthrough therapies using artificial intelligence (AI) and AI-enabling technologies to innovate small molecule discovery. The company is based in Boston, MA, and its engineers, chemists, and biologists collaborate on hard problems to find solutions that will have an enormous impact on patient health. For more information, visit www.deepcure.ai .

The Global Medical Device Nomenclature (GMDN) Agency alongside several partners including Guy’s and St Thomas’ NHS Foundation Trust have announced a funding award from Innovate UK, part of UK Research and Innovation, to research improvements in capturing post-market medical device intelligence to improve patient safety within the UK. The partners have been funded as part of a six-month discovery phase on a project called, transforming post-market intelligence to safely accelerate medical device innovation and adoption. The project lead is Dr Emmanuel Akinluyi, deputy chief medical officer and the chief biomedical engineer at Guy's & St Thomas' NHS Foundation Trust. He is also a consultant clinical scientist holding doctorates in Healthcare System Design and is the head of Methodology & deputy director of an NIHR HealthTech Research Centre. As principal investigator, he will lead the network, particularly its NHS-facing engagement. Speaking about the funding award, project lead, Dr Emmanuel Akinluyi, from Guy's & St Thomas' NHS Foundation Trust, said: “Medical devices impact every aspect of the public's interaction with the NHS, for prevention, screening, diagnosis, monitoring, and treating of diseases. The safety and effectiveness of these devices is critical to the quality of health outcomes. Traditionally, the great majority of medical device testing is done before they are used on patients ("pre-market"). Manufacturers are required to monitor their devices in clinical use ("post-market"), but in practice this is mainly limited to voluntary reporting and feedback from users. “We refer to this ongoing information about medical devices in clinical use as "post-market intelligence" The way we approach post market intelligence, has barely changed in decades. However, recent technological innovations mean that post-market intelligence could be transformed. These innovations include sophisticated medical device software, connected devices, innovative sensors, and growing hospital medical device databases, which are often managed by trained healthcare scientist staff. We believe that new opportunities can be created by connecting these new and enhanced sources of data about device safety and performance.” The project partners are King’s College London, GS1 UK, UCL, the GMDN Agency, Radar Healthcare, Panoramic Digital Health and Guy’s and St Thomas’ NHS Foundation Trust.

A single intra-articular injection of 3mL of MM-II provided greater pain relief than placebo for up to 26 weeks From weeks 12 to 26, more patients on MM-II experienced a ≥50% improvement in knee OA pain than patients on placebo and used less rescue medication MUMBAI, India and TEL AVIV, Israel, June 14, 2024 /PRNewswire/ -- Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Limited, and includes its subsidiaries or associate companies) and Israel-based Moebius Medical Limited today presented data demonstrating the durability of pain relief achieved in symptomatic knee OA patients through 26 weeks post injection of MM-II. The results, presented today at EULAR 2024, are based on an analysis from the randomized, controlled, Phase 2b clinical study (NCT04506463). An abstract presenting the data, entitled "Duration of Clinically Meaningful Analgesic Response to Intra-Articular MM-II, A Novel Suspension of Large, Empty, Multilamellar Liposomes, in Patients with Painful Knee Osteoarthritis: Analysis from a 26-Week Phase 2b Randomised Controlled Trial", was presented by Philip G. Conaghan, Professor of Musculoskeletal Medicine at the University of Leeds and Director of the NIHR Leeds Biomedical Research Centre. Prof. Conaghan commented, "Given the limitations of many current therapies, there is an urgent need for more therapeutic treatment options for patients with painful osteoarthritis. Data from the 3mL dose of MM-II in this trial demonstrate MM-II's potential to offer durable and meaningful pain relief with good tolerability." MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended to reduce friction and wear on the joint and thus relieve joint pain. Sun Pharma and Moebius Medical, who have been jointly developing this product, have announced plans to initiate a Phase 3 clinical program and to seek a CE Mark for the product in the European Union. Abhay Gandhi, CEO - North America Business, Sun Pharma, commented, "With over 100 million people currently suffering from joint pain, there is a significant unmet need for additional OA therapies. This analysis from our clinical trial is further confirmation of the potential role that MM-II will be able to play in improving painful OA treatment." Moshe Weinstein, CEO of Moebius Medical, added, "As more data become available, we continue to see MM-II's potential as a safe and effective alternative to today's OA treatments. We look forward to continuing development of our lead candidate with our partners at Sun Pharma." About Osteoarthritis Osteoarthritis (OA) is a common chronic degenerative joint disease, characterized by progressive wear of joint cartilage. Clinical manifestations of OA in the knee include, but are not limited to, pain in and around the joint and limited joint motion. Due to the inability of joint cartilage to self-heal, OA is among the most challenging joint diseases to treat, and currently no cure exists. The focus of current OA treatments is to reduce pain and improve function of the affected joints. Global estimates of OA exceed 100 million, and symptomatic OA afflicts more than 30 million Americans. Loss of joint function as a result of this condition is a major cause of work disability and reduced quality of life. About Moebius Medical Moebius Medical is a clinical stage biotechnology company that is developing novel pain relief treatments for osteoarthritis. The company was founded in 2008 within the RAD Biomed Accelerator to develop products based on a patent-protected technology licensed exclusively from Yissum, the Hebrew University Technology Transfer Company; T3, the Technology Transfer arm of the Technion Institute; and by Hadasit, the Technology Transfer company of Hadassah Medical Center. In 2016, Moebius entered a joint collaboration with Sun Pharma to develop MM-II. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world's leading specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). For further details, please contact: Media SUN PHARMA Gaurav Chugh Tel Direct: +91 22 4324 5373 Mobile: +91 98104 71414 Email: [email protected] MOEBIUS MEDICAL Moshe Weinstein Tel Direct: +972 3 768 4930 Email: [email protected] Investors SUN PHARMA Dr. Abhishek Sharma Tel Direct: +91 22 4324 2929 Mobile: +91 98196 86016 Email: [email protected] Disclaimer: Statements in this "document" describing Sun Pharma's and/or Moebius Medical's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Neither Sun Pharma nor Moebius Medical undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. SOURCE Moebius