RSLV-132

MIAMI--(BUSINESS WIRE)--Resolve Therapeutics, a leader in the emerging field of cell-free nucleic acid therapeutics, today announced a collaboration with the Department of Surgery, Duke University School of Medicine to analyze the role of cell-free RNA (cfRNA) in polytrauma www.resolvetherapeutics.com. A significant number of trauma patients admitted to the hospital each year suffer from polytrauma, with multiple, life-threatening injuries requiring immediate surgical intervention. Many of these patients experience poor clinical outcomes due to Systemic Inflammatory Response Syndrome (SIRS). The mechanism of SIRS in polytrauma patients is not completely understood but the current view holds that that massive tissue injury results in the release of large amounts of RNA into the blood overwhelming the activity of circulating RNase, which protects cells from the inflammatory effects of cfRNA under normal circumstances. The accumulating cfRNA activates several key mechanisms driving local and systemic inflammation which leads to increased morbidity and mortality. “Preventing systemic inflammation in polytrauma would be a large step forward in the treatment paradigm for these patients,” said Allan D. Kirk, MD, PhD, Chair of the Department of Surgery at Duke University. Working closely with the world’s foremost trauma surgeons at Duke University, Resolve and Duke will conduct an observational study to analyze the presence, structure, and drug targeting of cfRNA in a selected population of polytrauma patients. Based on the results of this work, a proof-of-concept clinical trial with RSLV-132 (a fully human, catalytically active, RNase Fc fusion protein) may be undertaken seeking to improve clinical outcomes for polytrauma patients by removing circulating inflammatory nucleic acids. “We are thrilled to work with the world class physician scientists within the Duke University School of Medicine and are hopeful our work together may lead to an improvement in the outcome for patients with polytrauma,” commented Dr. James Posada chief executive officer of Resolve Therapeutics. “Duke Surgery offers a unique environment, coupling state of the art patient care with basic research expertise and infrastructure to enable systematic molecular analysis of plasma-borne inflammatory nucleic acids.” “Preventing systemic inflammation in polytrauma would be a large step forward in the treatment paradigm for these patients,” said Allan D. Kirk, MD, PhD, Chair of the Department of Surgery at Duke University. “We look forward to the collaboration with Resolve and learning more about the underlying mechanisms of inflammation in critically injured patients,” he added. About RSLV-132 RSLV-132 is a safe, fully-human, non-immunosuppressive, non-immunogenic, biologic drug with a three-week serum half-life. The drug is comprised of catalytically active human RNase fused to an engineered Fc region of human IgG1. It is designed to remain in circulation and digest extracellular pathogenic RNA in diseases where the presence of cfRNA drives the inflammatory process. RSLV-132 has proven safe in five clinical trials and has demonstrated improvement in autoimmune symptoms in phase 2 clinical trials in both systemic lupus erythematosus and Sjogren’s syndrome. About Resolve Therapeutics Resolve is a biopharmaceutical company at the forefront of the emerging field of cell-free nucleic acids in disease. We are developing RSLV-132 and RSLV-145 in a broad range of acute and chronic diseases that are driven by cell-free RNA, cell-free DNA, and Neutrophil Extracellular Traps (NETs). For more information or to discuss our programs please visit: https://resolvetherapeutics.com/

MIAMI, May 13, 2024 /PRNewswire/ -- Resolve Therapeutics, a mid-stage clinical development company pioneering transformative therapies for autoimmune and post-viral illnesses, today announced the publication of its phase 2 long COVID results in Clinical Infectious Diseases. The publication entitled "Assessment of the Impact of RNase in Patients with Severe Fatigue Related to Post-Acute Sequelae of SARS-CoV-2 Infection (PASC): A randomized phase 2 trial of RSLV-132" evaluated the impact of RNase in one hundred and eight patients diagnosed with COVID-19 at least 6 months prior to baseline and with a history of continuous, severe fatigue. Participants received 6 doses of RSLV-132 or placebo over two months. The study measured fatigue and overall disease activity using the PROMIS SF 10a, FACIT-Fatigue, and physician's global assessment. Approximately 18 million Americans suffer the debilitating effects of long COVID. The most common symptoms are extreme fatigue, brain fog, immune dysregulation and depression or anxiety. Despite the large unmet medical need, A recent editorial in The Lancet identified only 12 pharmacological interventional clinical trials in development. Thus, very little progress has been made towards identifying drugs to treat the cardinal symptoms of long COVID. RSLV-132 has demonstrated significant clinical activity in improving autoimmune-related fatigue in Sjogren's syndrome. Results from the current long COVID phase 2 study suggest patients suffering from long COVID may also benefit from the removal of circulating RNA. "We are encouraged by the potential for RSLV-132 to improve the debilitating fatigue suffered by so many long COVID patients" commented Dr. James Posada chief executive officer of Resolve Therapeutics. "Interestingly, our data further suggests that women may respond better to RSLV-132 and digestion of latent viral RNA than men" added Dr. Posada. About RSLV-132 RSLV-132 is a non-immunosuppressive, biologic drug comprised of catalytically active human RNase1 fused to the Fc region of human IgG1. It is designed to remain in serum circulation and digest extracellular pathogenic RNA. RNA is the primary trigger of interferon and cytokine production that drives chronic inflammation in diseases such as SLE, Sjogren's. Recent studies suggest that RNA may play a role in post-viral illnesses such as PASC and ME/CFS as well. Therefore, removing it from circulation may decrease inflammation and improve the symptoms associated with these diseases. About Resolve Therapeutics Resolve is a private biotech company pioneering a transformative approach to autoimmune and post-viral diseases. The company is leveraging the extensive body of scientific discoveries that demonstrate the central role of pathogenic RNA molecules, weather self-derived or from viral sources, in driving inflammatory and neuroinflammatory symptoms. Resolve is actively developing RSLV-132 in mid-stage clinical development programs including SLE, Sjogren's syndrome, and post-acute sequelae of SARS-CoV-2 infection (PASC). For more information please visit: Contact: James Posada Resolve Therapeutics 208-727-7010 [email protected] SOURCE Resolve Therapeutics, LLC