Inflammasome Therapeutics, Inc.

NEWTON, Mass.--( BUSINESS WIRE )--Inflammasome Therapeutics, a private company, has completed enrollment of a Phase I PK/Safety study of its new brain- and retina-penetrant drug K9, which has application in the treatment of multiple neuroinflammatory, degenerative diseases (such as Alzheimer’s, MS, ALS, Parkinson’s, geographic atrophy) and autoimmune diseases such as lupus and thyroid eye disease. “These diseases all involve a type of inflammation called inflammasome activation, and the activation of two specific inflammasomes catalyzes the progression of these diseases. K9, taken as a tablet, penetrates the brain and retina and blocks both inflammasomes,” said Dr. Paul Ashton, CEO and cofounder of Inflammasome Therapeutics. “Drugs that block a single inflammasome have been found to have only moderate or no efficacy in models of MS and macular degeneration; we have seen dramatically superior results with our Kamuvudine molecules that block multiple inflammasomes.” Delivering therapies across the tightly controlled blood-brain and blood-retina barriers to reach disease targets that are responsible for driving smoldering neuroinflammation within the central nervous system has been a formidable challenge in advancing innovation in neurological and retinal diseases. “Our data reveal that Kamuvudines have disease-modifying potential by targeting inflammation directly in the central nervous system as well as in the periphery,” said Dr. Jayakrishna Ambati, Inflammasome Therapeutics’ co-founder. The successful completion of this study paves the way for further clinical trials of the drug, which Inflammasome Therapeutics expects to commence later this year. The company’s other dual inflammasome inhibitor entered clinical trials earlier this year for geographic atrophy, a late stage of macular degeneration that is one of the most common causes of blindness in the elderly without a meaningfully effective treatment. That drug, K8, is delivered via a sustained delivery implant that is injected directly into the eye and releases minute but effective amounts of drug for three months. Dr. Ambati has spent more than a decade leading research into the role of inflammasomes in triggering the inflammation that is believed to be the underlying cause of several neurodegenerative, autoimmune, and ophthalmic conditions for which there are no cures. Earlier, his research found that people taking a type of anti-HIV drug (called NRTIs) have a far lower risk of developing Alzheimer’s disease and geographic atrophy. Unfortunately, NRTIs also have substantial toxicity. This led Dr. Ambati and his team to create new molecules formed by altering the structure of NRTIs to remove their toxicity creating a new class of drugs, Kamuvudines. Kamuvudines, have the same inflammasome-inhibiting action as their predecessors, but none of the toxicity. Inflammasome Therapeutics ( https://www.inflam.com ) was founded by Jayakrishna Ambati, M.D. and Paul Ashton, Ph.D. to advance therapies for prevalent, degenerative diseases and to advance novel delivery technologies for sustained release of therapeutic agents and compounds. The company combines scientific excellence with proven development expertise and works to create breakthrough products via a mixture of licensing agreements and internal development.

Dr. David J. Bearss, CEO, will present data from the Phase II study evaluating the efficacy of HT-6184 on post-procedural inflammatory and pain responses on Thursday, September 12, 2024 LEHI, Utah, Sept. 10, 2024 /PRNewswire/ -- Halia Therapeutics, Inc. (Halia), a clinical-stage biopharmaceutical company at the forefront of developing innovative treatments for inflammatory and neurodegenerative diseases, today announced that David J. Bearss, Ph.D., President and CEO of Halia Therapeutics, will present results from Halia's completed Phase II randomized, single-dose, placebo-controlled, double-blind, parallel-group clinical study (NCT06241742) evaluating the efficacy of HT-6184 in post-procedural inflammatory and pain responses at the upcoming 6th Inflammasome Therapeutics Summit taking place September 10-12, 2024, in Boston, MA. HT-6184 is a first-in-class, selective, and orally bioavailable inhibitor of the NEK7/NLRP3 inflammasome. Halia's investigational drug is designed to improve patients' lives by targeting chronic inflammatory disorders and neurodegenerative diseases. Presentation Details: Title: Leveraging Inflammatory-Induced Pain as an Innovative & Alternative Endpoint for a Time-Effective Measurement of Therapeutic Benefit Date: September 12, 2024 Time: 8 a.m. ET Presenter: David J. Bearss, Ph.D., President and Chief Executive Officer, Halia Therapeutics Session: From Biomarkers to Endpoint & Even Clinical Trial Design: Innovations in Clinical Development Strategies to Advance Inflammasome Therapeutics Dr. Bearss will also participate in the panel discussion: 'What are the Future Directions of the Inflammasome Therapeutics Landscape? A Glimpse into the Next 5 Years' which will take place on September 12 at 2:30 p.m. ET. The Inflammasome Therapeutics Summit is an annual event focused on advancing the development of inflammasome-targeting therapies. This summit gathers biopharma professionals and top academics in the field to offer exclusive clinical insights as well as to discuss the latest advancements in inflammasome research. To view the full agenda, please visit . About HT-6184 Clinical Trial to Reduce Inflammation and Pain The clinical trial (NCT06241742) is a Phase II randomized, single-dose, placebo-controlled, double-blind, parallel-group study designed to evaluate the ability of HT-6184 to attenuate diagnostic biomarkers of post-procedure acute inflammation and manage pain following third molar extraction. Subjects were given a single oral dose of HT-6184 or placebo before oral surgery to remove their third molar teeth and were monitored for safety and to rate their pain intensity and for biomarkers of post-procedure acute inflammation after surgery. The study was conducted at CenExcel JBR in Salt Lake City, Utah. About the Post Procedural Inflammatory Response Globally, over 300 million major surgical procedures are performed each year1. Many of these surgeries lead to inflammatory responses that complicate recovery and lead to acute pain and loss of productivity for patients recovering from the surgery. About NLRP3 NLRP3, an innate immune sensor, is activated in response to various pathogenic and sterile stimuli. Activation of NLRP3 triggers the release of the pro-inflammatory cytokines IL-1β and IL-18 and induces a lytic cell death process called pyroptosis. These processes lead to systemic chronic inflammation. Halia scientists and our collaborators have shown that HT-6184 inhibition of NLRP3 in preclinical models prevents the formation of the NLRP3 inflammasome and promotes its disassembly once formed, thereby inhibiting the production and release of IL-1β and IL-18. Persistent activation of the NLRP3 inflammasome is thought to drive the onset and progression of many conditions, including fibrotic, dermatological, and auto-inflammatory diseases. Significant neurodegenerative and neuroinflammatory disorders such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis are also driven by NLRP3 activation. About HT-6184 HT-6184 represents an innovative approach as it is the first drug candidate to target the protein NEK7 through an allosteric mechanism. NEK7 is an essential component of the NLRP3 inflammasome and is critical for its assembly and the maintenance of NLRP3 activity. In preclinical models, Halia has shown that inhibiting the ability of NEK7 to bind to NLRP3 leads to a disruption in the formation of the NLRP3 inflammasome complex, thereby inhibiting the signaling from the inflammasome and reducing the inflammatory response. Preclinical models also showed that in addition to disrupting the formation of the NLRP3 inflammasome, HT-6184 promotes the disassembly of the inflammasome once activated (Halia unpublished data). About Halia Therapeutics, Inc. Halia Therapeutics is discovering and developing a pipeline of novel therapeutics to improve patients' lives with chronic inflammatory disorders and neurodegenerative diseases, with its initial programs targeting NEK7 and LRRK2. Halia's lead candidate, HT-6184, a novel NEK7/NLRP3 inhibitor, has completed a Phase I study (NCT05447546) evaluating the safety and tolerability of HT-6184 when administered as single or multiple oral doses at escalating dose levels in healthy volunteer subjects and has also completed a Phase II trial evaluating the efficacy of HT-6184 on post-procedure diagnostic biomarkers of inflammation and pain (NCT06241742). Halia is currently undergoing a Phase II trial investigating the efficacy of HT-6184 for the treatment of lower-risk myelodysplastic syndromes (LR-MDS). The company's headquarters are in Lehi, Utah. For more information, visit or follow us on LinkedIn and Twitter (X). Company Contact Halia Therapeutics [email protected] +1 (385) 355-4315 Media Contact: Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC +1 (646) 942-5604 [email protected] References: Meara, John G., Andrew JM Leather, Lars Hagander, Blake C. Alkire, Nivaldo Alonso, Emmanuel A. Ameh, et al. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. The Lancet. 2015; 386: 569-624 SOURCE Halia Therapeutics

Investments from Pharmaceutical Entities in R&D Endeavors Increasing to Enhance Uveitis Treatment Efficacy and Patient Outcomes ROCKVILLE, Md., July 16, 2024 /PRNewswire/ -- According to a recently released industry report by Fact.MR, the global Uveitis Treatment Market is poised to be valued at US$ 791 million in 2024 and further expand at 5.8% CAGR from 2024 to 2034. Technological advancements in therapy approaches, particularly in the creation of sustained-release drug delivery devices, are key factors driving uveitis treatment market growth. Advanced treatment methods, which include biodegradable microspheres and intravitreal implants, provide significant advantages since they directly administer prolonged pharmaceutical exposure to the affected eye tissues. Reducing the need for repeated injections or systemic medications lowers the risk of undesirable systemic effects while increasing patient compliance and convenience. The rising incidence of uveitis in some countries due to the increasing aging population, a rise in the prevalence of autoimmune disorders, and a focus on improving diagnostic capabilities are major aspects driving the growth of the market for uveitis treatment. Increased funding from pharmaceutical companies and organizations for research and development initiatives aimed at uveitis treatment is driving the exploration of new medicinal agents and treatment strategies. For More Insights into the Market, Request a Sample of this Report: Key Takeaways from the Market Study The global market for uveitis treatment is projected to reach US$ 1.4 billion by 2034-end. North America is estimated to hold 36.8% of the global market share in 2024. Demand for uveitis treatment in East Asia is estimated at a market value of US$ 117 million in 2024. The Canada market is evaluated to generate revenue of US$ 90 million by 2034-end. The market in South Korea is forecasted to expand at a CAGR of 9.4% from 2024 to 2034. Based on disease, the anterior uveitis segment is forecasted to hold 59.5% of the global market share by 2034. In the North American region, the United States is expected to lead the market with a 73.4% revenue share in 2024. "Revenue from uveitis treatment is growing at a steady pace as a result of ongoing advancements such as sustained-release medication delivery techniques that improve patient convenience and therapeutic efficacy," says a Fact.MR analyst. Leading Players Driving Innovation in the Uveitis Treatment Market Key players in the uveitis treatment industry are Sun Pharmaceutical Industries Ltd., EyePoint Pharmaceuticals, Inc., Ophthotech Corporation, Regeneron Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited, Inflammasome Therapeutics Inc., Graybug Vision, Inc., TopiVert Pharma Ltd., Pfizer Inc., Bausch Health Companies Inc. Hospital Pharmacies Account for Substantial Market Share Hospital pharmacies are generating substantial revenue compared to other distribution channels such as retail pharmacies, online pharmacies, and drug stores. Hospital pharmacies face a constant need for uveitis medications since uveitis is a fairly common condition that requires ongoing care and because hospitals often have a big patient base. Hospitals benefit financially from treating an increasing number of uveitis patients who require continuous access to the prescribed medications. Hospital pharmacies benefit from discounted rates on these medications due to contracts with specific suppliers of uveitis medications. Uveitis Treatment Industry News: Targeting non-infectious uveitis, including uveitic glaucoma, Tarsier Pharma received FDA permission in January 2024 for the Tarsier-04 Phase 3 trial of the TRS01 ocular solution under the Special Protocol Assessment (SPA). The FDA approved triamcinolone acetonide injectable suspension, or XIPER, in October 2021 for use as a suprachoroidal medication to treat retinal edema associated with uveitis. Targeting non-infectious posterior segment uveitis (NIPU) and diabetic macular edema (DME), Alimera Sciences Europe Ltd. launched ILUVIEN in the Netherlands in December 2020 to expand geographically to reach more doctors and patients. Get Customization on this Report for Specific Research Solutions: Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Treatment: Corticosteroids Immunosuppressants Monoclonal Antibodies Cycloplegic Agents Antibiotics Antivirals Antifungals Analgesics Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Disease: Anterior Uveitis Posterior Uveitis Intermediate Uveitis Panuveitis Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Cause: Infectious Uveitis Non-infectious Uveitis Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Distribution Channel: Hospital Pharmacies Retail Pharmacies Online Pharmacies Drug Stores More Valuable Insights: Fact.MR, in its new offering, presents an unbiased analysis of the uveitis treatment market, presenting historical demand data (2019 to 2023) and forecast statistics for 2024 to 2034. The study divulges essential insights into the market based on treatment (corticosteroids, immunosuppressants, monoclonal antibodies, cycloplegic agents, antibiotics, antivirals, antifungals, analgesics), disease (anterior uveitis, posterior uveitis, intermediate uveitis, panuveitis), cause (infectious uveitis, non-infectious uveitis), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies, drug stores), across seven major regions of the world (North America, Western Europe, Eastern Europe, East Asia, Latin America, South Asia & Pacific, and MEA). Check out More Related Studies Published by Fact.MR: Eye Health Supplements Market stands at US$ 1.9 billion in 2023 and is forecasted to reach US$ 3.5 billion by the end of 2033, increasing at a CAGR of 6.2%. Dry Eye Syndrome Treatment Market is anticipated to be worth US$ 4,027.2 million in 2024 and is expected to expand to an astounding size of US$ 10,961.2 million by 2034. Rare Neurological Disease Treatment Market is projected to expand at a stellar CAGR of over 8.5% and is anticipated to grow 2.3x between 2018 and 2028. Ophthalmic Drugs Market is valued at US$ 38 billion in 2023 and is thus anticipated to reach US$ 72 billion by 2033. Ocular Drug Delivery Technology Market is poised to flourish at a CAGR of 8.2% to reach a value of US$ 39 Billion by 2032. Refsum Disease Treatment Market is predicted to accelerate at a CAGR of 5.6% and reach a market valuation of US$ 2.56 billion by the end of 2033. About Us: Fact.MR is a distinguished market research company renowned for its comprehensive market reports and invaluable business insights. As a prominent player in business intelligence, we deliver deep analysis, uncovering market trends, growth paths, and competitive landscapes. Renowned for its commitment to accuracy and reliability, we empower businesses with crucial data and strategic recommendations, facilitating informed decision-making and enhancing market positioning. With its unwavering dedication to providing reliable market intelligence, FACT.MR continues to assist companies in navigating dynamic market challenges with confidence and achieving long-term success. With a global presence and a team of experienced analysts, FACT.MR ensures its clients receive actionable insights to capitalize on emerging opportunities and stay competitive. Contact: 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 Sales Team: [email protected] Follow Us: LinkedIn | Twitter | Blog SOURCE Fact.MR