EYD-001

DURHAM, N.C., Sept. 25, 2024 /PRNewswire/ -- EydisBio, Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to EYD-001, its highly selective and potent, orally bioavailable TAK1 inhibitor for the treatment of systemic sclerosis. EydisBio is an early-stage pharmaceutical company leveraging a novel approach to treating various autoimmune and inflammatory diseases, including rare diseases. For more information about the Company, their developmental programs and pioneering research, please visit . Systemic sclerosis is a rare and debilitating autoimmune disease characterized by fibrosis of the skin and internal organs, leading to significant morbidity and mortality. Central to the disease's pathogenesis is the transforming growth factor-β (TGF-β) pathway, with TAK1 playing a pivotal role. Activation of this pathway triggers inflammation and fibrosis, the hallmark features of systemic sclerosis, and novel inhibition of this pathway via TAK1 represents a promising approach to disease treatment. EydisBio's preclinical data published last year, in collaboration with Dr. John Varga, MD and his ScleroLab research group at the University of Michigan, showed that EYD-001 (formerly known as HS-276) significantly reduced both dermal thickening and p-TAK1 expression in the lungs of a bleomycin-induced mouse model of systemic sclerosis. Moreover, in patient-derived skin fibroblasts, treatment with EYD-001 significantly reduced mRNA expression of fibroinflammatory genes and blocked TGFβ-mediated increases in fibrotic protein expression. The FDA's Orphan Drug Designation recognizes the potential of EydisBio's TAK1 inhibitor to address this unmet medical need, highlighting the importance of these findings and the promise of EYD-001 as a novel therapeutic option for patients suffering from systemic sclerosis. "We are excited to receive this designation from the FDA, which underscores the potential of our TAK1 inhibitor to make a meaningful impact on the lives of patients suffering from systemic sclerosis," said Dr. Tim Haystead, Founder and President of EydisBio. "This recognition highlights the innovative nature of our research and the dedication of our team to advancing treatments for rare diseases. It also strengthens our commitment to bringing EYD-001 to systemic sclerosis patients as swiftly and safely as possible." The Orphan Drug Designation is a significant milestone for any company, especially for those developing treatments for rare diseases affecting fewer than 200,000 people in the United States. This designation offers several key benefits, including seven years of market exclusivity upon approval, which protects the product from direct competition. Companies also receive tax credits for clinical trial costs, alleviating the financial burden of drug development. Additionally, the FDA provides essential support in clinical trial design and waives prescription drug user fees, streamlining the development process. These incentives collectively enable companies to bring innovative treatments to market more efficiently, ultimately benefiting patients with rare conditions. EydisBio is committed to advancing the development of its TAK1 inhibitor program and plans to initiate clinical trials in the near future. The company will continue to work closely with the FDA to bring this promising therapy to patients affected by systemic sclerosis as quickly as possible. Media Contact: Robert Freeze, [email protected] SOURCE EydisBio, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DURHAM, N.C., Aug. 28, 2024 /PRNewswire/ -- EydisBio, an early-stage pharmaceutical company leveraging a novel approach to treating various autoimmune and inflammatory diseases, is thrilled to announce that it has been awarded a $2.6 million Phase 2 Small Business Innovation Research (SBIR) grant from the National Institute of Health's (NIH) National Heart, Lung, and Blood Institute (NHLBI). This grant will further support EydisBio's ongoing research into the efficacy of TAK1 inhibition in animal models of systemic sclerosis and declare a lead compound for progression into the clinic. "We are honored to receive this significant grant from the NHLBI," said Dr. Tim Haystead, Founder and President of EydisBio. "This funding will enable us to continue to advance our TAK1 inhibitor program in systemic sclerosis and bring us closer to developing a new therapeutic option for these patients. We are strongly committed to improving the lives of those affected by this debilitating disease." Systemic sclerosis, also known as scleroderma, is a rare chronic autoimmune disease characterized by hardening and tightening of the skin and connective tissues. It can also affect internal organs, leading to severe complications. Current treatments focus on managing symptoms and slowing disease progression, mainly for patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), but clinical benefit is highly limited and there is no cure. Moreover, no novel therapies have been approved for addressing manifestations beyond SSc-ILD, all of which highlights a critical unmet need across the entire systemic sclerosis disease spectrum. Aberrant TAK1 signaling plays a pivotal role in the pathophysiological cycle of inflammation, fibrosis, and vasculopathy that drives systemic sclerosis, and inhibition of this pathway represents a novel therapeutic strategy. EydisBio's TAK1 inhibitors have demonstrated significant promise in recent preclinical studies involving fibroblasts derived from systemic sclerosis patients and a bleomycin-induced mouse model of the disease. This project will support continued analog development to identify a highly effective and safe lead compound and further investigate its potential for treating SSc-ILD and related manifestations. Following this, EydisBio will undertake GLP-compliant toxicity studies to support the advancement of the program through Investigational New Drug (IND) filing and into clinical trials. For more information about EydisBio and their groundbreaking research, please visit . Media Contact: Robert Freeze [email protected] SOURCE EydisBio, Inc.