TAK1 subfamily

DURHAM, N.C., Oct. 23, 2024 /PRNewswire/ -- EydisBio, an innovative pharmaceutical company dedicated to developing novel treatments for various autoimmune and inflammatory diseases, is excited to announce that it has been awarded a $0.5 million Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health's (NIH) National Institute on Aging (NIA). This grant will support EydisBio's pioneering research into new therapeutic approaches for Alzheimer's disease, focusing on the inhibition of TGFβ-activated protein kinase 1 (TAK1). The project will be conducted in collaboration with Dr. Jun Ninomiya-Tsuji and her team at North Carolina State University who are focusing on understanding the molecular mechanisms of TAK1 and its role in driving various inflammatory-diseases. For more information about EydisBio and their groundbreaking research, please visit . "We are deeply honored to receive this NIH grant and to collaborate with Dr. Jun Ninomiya-Tsuji and her distinguished team at North Carolina State University," said Dr. Tim Haystead, Founder and President of EydisBio. "This funding empowers us to investigate innovative approaches in Alzheimer's disease research, bringing us closer to developing effective treatments for this devastating condition. Together, we are dedicated to making a meaningful impact on the lives of patients and their families." Alzheimer's disease is a progressive neurodegenerative disorder that affects millions of people worldwide, leading to memory loss, cognitive decline, and ultimately, loss of independence. Current treatments offer limited symptomatic relief, and there is a critical need for innovative therapies that can slow or halt disease progression. EydisBio's research focuses on targeting TAK1, a critical regulator of neuronal necrosis and neuroinflammation in Alzheimer's disease. Preliminary studies have shown that TAK1 signaling contributes to both neuroinflammatory and necroptotic pathways, which are key drivers of neuronal death in Alzheimer's disease. By inhibiting TAK1, EydisBio aims to reduce neuroinflammation and neuronal damage, offering a potential new strategy for treating the disease. Key findings from EydisBio's preclinical work include: Identification of TAK1 as a critical mediator: TAK1 regulates TNF and glutamate signaling in neurons, switching from inflammatory to necroptotic signaling, which contributes to neuronal death. Efficacy of TAK1 inhibition: Genetic and pharmacological inhibition of TAK1 has been shown to rescue neuronal loss in preclinical models of Alzheimer's disease. Development of selective TAK1 inhibitors: EydisBio has developed a series of TAK1 inhibitors with low nanomolar potency, selectivity within the human kinome, and oral bioavailability. These inhibitors have demonstrated significant promise in reducing neuroinflammation and neuronal necrosis in preclinical studies. The Phase I SBIR grant will fund further preclinical studies to validate these findings and identify lead compounds for future development. This project aims to generate critical preclinical data on the viability of targeting the TAK1 pathway as a novel therapy for Alzheimer's disease. 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., 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

Results affirm the advantages of Prota's remission peanut OIT treatments, which lead to significant and sustained benefits including substantially improved Health Related Quality of Life Study underscores the need to aim for remission as the optimal treatment outcome. Highlights significant long-term benefits provided by two high-dose peanut oral immunotherapy treatments that induce remission of allergy. MELBOURNE, Australia, Aug. 14, 2024 /PRNewswire/ -- Prota Therapeutics Pty Ltd (Prota), an Australian clinical-stage biotechnology company focused on the development of novel oral immunotherapy treatments that induce remission of allergy, today announced publication in the journal Allergy of the first long-term study directly comparing remission and desensitization endpoints following food allergen oral immunotherapy (OIT). The Phase 2b follow-on study also reports 2-year post-treatment outcomes for Prota's remission-inducing high-dose peanut oral immunotherapies: PRT120, a standalone high-dose OIT, and PRT100, a probiotic OIT combination treatment, which were previously shown to induce remission of peanut allergy in 51% and 46% of treated patients, respectively. Continue Reading Groundbreaking Study Reveals Long-Term Benefits of Achieving Remission with Prota Therapeutics’ Novel Peanut Allergy Treatments: The latest findings from the PPOIT-003LT study highlight the enduring benefits of Prota’s high-dose remission-inducing oral immunotherapies, including substantially improved health related quality of life. The PPOIT-003LT study, a continuation of the Phase 2b PPOIT-003 randomized, multi-center trial, provides significant insights into the long-term outcomes of children who received one of two remission-inducing high-dose peanut oral immunotherapies: a Peanut Oral Immunotherapy on its own (OIT) or a combined Probiotic Peanut Oral Immunotherapy (PPOIT). The study directly compared the long-term benefits and risks associated with the different treatment outcomes -- remission, desensitization and allergy, and also reported long-term outcomes for OIT and PPOIT compared to placebo. Findings validate remission as a preferred outcome to desensitization. Participants who achieved remission following treatment were able to stop treatment and safely consume peanuts freely. At two years after completing treatment, remission participants reported fewer peanut ingestion reactions, with no moderate or severe reactions, no rescue epinephrine injector use, and most importantly, significantly greater improvement in quality of life compared to participants who only achieved desensitization. Participants who were only desensitized had difficulty maintaining their required daily peanut ingestion dose and continued to report severe reactions that required rescue epinephrine treatment. They did not experience any improvement in quality of life compared to the allergic group. Findings also confirmed that both the high-dose OIT (PRT120) and the combination PPOIT (PRT100) treatments provide lasting benefits that persist or are improved upon during the 2-year period after stopping treatment. At 2-years after completing treatment with either PRT120 or PRT100, children experienced fewer reactions over time, and continued to enjoy significantly improved health related quality of life (HRQOL) compared to the placebo group. Key Findings A standalone high-dose peanut oral immunotherapy (OIT) and a combination probiotic high-dose peanut oral immunotherapy (PPOIT) that induced remission of peanut allergy in 51% and 46% of treated patients, respectively, were shown to provide lasting benefits at 2-years after treatment, including significantly improved quality of life compared with placebo-treated patients. Participants with remission were half as likely to have an allergic reaction to peanut compared with desensitized patients (15.9% in the remission group, 36.8% in the desensitized group). In the 2nd-year after treatment, remission participants had no moderate or severe reactions and no rescue epinephrine use; whereas 24% of reactions in desensitized participants were moderate or severe, and 14.3% of desensitized participants required rescue epinephrine to treat reactions. Participants who achieved remission reported substantial and clinically meaningful improvement in health-related quality of life (HRQOL) compared with both desensitized participants and those who remained allergic; whereas participants who were only desensitized (without remission) showed no improvement in HRQOL compared with allergic participants. Study Design Participants: 151 of the 176 (86%) eligible children aged 1-10 with confirmed peanut allergy who completed the Phase 2b PPOIT-003 randomized trial. Study endpoints: Comparison of long-term outcomes by clinical allergy status: remission, desensitization (without remission) and persistent allergy; comparison of long-term outcomes by treatment group: High-dose peanut oral immunotherapy (OIT), Probiotic Peanut Oral Immunotherapy (PPOIT), and placebo. Outcomes Measured: Peanut ingestion, reactions, and health-related quality of life (HRQOL) at 1-year and 2-years after treatment. Summary The follow-on study, PPOIT-003LT, showed two key findings: Remission is a demonstrably better outcome for patients than only being desensitized or remaining allergic. Remission participants reported fewer and milder allergic reactions to peanut (with no requirement for rescue epinephrine) compared to desensitized patients and, most importantly, experienced substantially better quality of life compared to both desensitized and allergic participants. The clinical benefits of both the high-dose OIT (Prota's lead product, PRT120) and PPOIT are sustained or even improved upon in the long-term, with continuing reductions in reactions to peanut over time, particularly for remission participants, and lasting quality of life improvements compared with placebo treatment. Among benefits of achieving remission Freedom from ongoing treatment. Reduction in allergic reactions, and in severity of reactions. Substantial HRQOL improvements. Positive attitudes toward peanut consumption. Psychological benefits including reduced anxiety. According to the study Principal Investigator, Paxton Loke, Ph.D., Research Clinician in the Allergy Immunology group at the Murdoch Children's Research Institute (MCRI), "Remission offers a more favorable long-term outcome in terms of reduced reactions and improved quality of life compared to desensitization without remission or persistent allergy. This study underscores the need to aim for remission as the optimal clinical outcome." "The findings from the PPOIT-003LT study highlight the significant benefits of achieving remission through PRT120 treatment, a high-dose rapid escalation oral immunotherapy for peanut allergies," said Lead Investigator Professor Mimi Tang, Ph.D., Director of the Allergy Translation Centre and Head of Allergy Immunology at the Murdoch Children's Research Institute (MCRI), and CEO of Prota Therapeutics. About Prota Therapeutics Prota Therapeutics is an Australian proprietary limited late clinical-stage biotech company dedicated to advancing allergen oral immunotherapies for treating food allergies, particularly addressing the prevalent and potentially life-threatening issue of peanut allergy. Established in 2016 to develop and commercialize novel oral immunotherapy treatments, Prota holds an exclusive license to the proprietary food immunotherapy technology developed at the Murdoch Children's Research Institute (MCRI). For more information please visit: . About Murdoch Children's Research Institute Murdoch Children's Research Institute is the largest child health research institute in Australia committed to making discoveries and developing treatments to improve child and adolescent health in Australia and around the world. They are pioneering new treatments, trialling better vaccines and improving ways of diagnosing and helping sick babies, children and adolescents. It is one of the only research institutes in Australia to offer genetic testing to find answers for families of children with previously undiagnosed conditions. SOURCE Prota Therapeutics