BioAegis Therapeutics, Inc.

AV-001 is designed to improve lung healing in patients by providing a molecular shortcut in blood vessel growth associated with wound closure. Credits: Marko Aliaksandr/Shutterstock.com Vasomune Therapeutics has announced that its novel investigational medicine, AV-001, has received US Food and Drug Administration (FDA) fast track designation for the treatment of moderate to severe pathogen-induced acute respiratory distress syndrome (ARDS). Recommended Buyer's Guides Buyer's Guide Top Guide for Drug Delivery Systems Buyer's Guide Top Guide for Cleanrooms and Cleanroom Flooring As per the 28 May press release, fast track designation was granted based on the high unmet medical need in ARDS. The status allows for earlier interactions with the FDA in the pursuit of accelerated approval and also the possibility to undergo rolling reviews. ARDS is a life-threatening lung injury that enables fluid to leak into the lungs, causing breathing difficulties and low blood oxygen. According to the press announcement, ARDS is characterised by high mortality rates that can reach up to 46% in patients with severe cases of the disease. AV-001, a polyethylene glycol (PEG)-clustered Tie2 agonist peptide that was first discovered at Sunnybrook Research Institute at Sunnybrook Hospital, is designed to improve healing in patients by providing a molecular shortcut in blood vessel growth associated with wound closure. The drug candidate is actively being evaluated in a Phase IIa study (NCT05123755) for the prevention and treatment of hospitalised patients with pneumonia-associated ARDS. The primary endpoint of the study is the safety and tolerability of multiple intravenously administered doses of AV-001 compared to placebo. See Also: MSD agrees to acquire EyeBio for up to $3bn Merck introduces sterility testing solution for pharma quality control The Phase I study (NCT04737486) demonstrated a good safety and tolerability profile with strong on-target activity. There were no drug-related discontinuations or deaths, no suspected unexpected severe adverse reactions (SUSARs), and no adverse events of special interest (AESIs), as reported at the 2024 Respiratory Innovation Summit (RIS). “Vasomune is focused on the persisting unmet needs of people grappling with ARDS and other diseases driven by vascular endothelial instability,” said president and Chief Operating Officer of Vasomune, Dr. Brian Jahns. The Toronto, Ontario-based biotech is not the only player in the ARDS space. In October 2023, BioAegis Therapeutics was awarded a $20m contract from the US Biomedical Advanced Research and Development Authority (BARDA) for the development of plasma gelsolin for the treatment of ARDS. Also making headway is Healios, which in April 2023, reported positive topline results from the open-label ONE-BRIDGE clinical study of somatic stem cell regenerative therapy MultiStem (HLCM051/invimestrocel) in ARDS patients across Japan.

Feb. 27, 2024 -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce site recruitment for BTI-203, a Phase 2 study of recombinant human gelsolin (rhu-pGSN) for the treatment of Acute Respiratory Distress Syndrome (ARDS) (NCT05947955). The study, A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Recombinant Human Plasma Gelsolin With Standard of Care for Moderate-to-Severe ARDS Due to Pneumonia or Other Infections is being conducted under a contract with BARDA’s Division of Research, Innovation, and Ventures (DRIVe), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study. Enrollment is targeted for 600 subjects. The planned primary outcomes are all-cause mortality at Day 28 between treatment groups and incidence, causality, and severity of SAEs in rhu-pGSN vs placebo treatment. ARDS is a condition that can develop as a severe complication of sepsis, trauma, pneumonia or other infectious diseases, resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system. Even with aggressive medical management, a substantial number of patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions. The mortality rate for ARDS is approximately 40%. The lack of effective therapies to treat ARDS and its associated high mortality driven by excess inflammation underscores the urgent need for an innovative therapy in this field. Plasma gelsolin holds immense promise as a therapeutic intervention for ARDS due to its multifaceted mechanism of action. Gelsolin has demonstrated the ability to: Modulate the activation of the NLRP3 inflammasome and generation of IL-1β-containing microparticles Facilitate uptake and killing of microbial pathogens by innate immune cells Bind to and remove harmful inflammatory mediators Regulate macrophage phenotype to modulate inflammation Gelsolin is a naturally occurring human protein found in the bloodstream, which is depleted by counteracting the inflammatory process. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated with ARDS. "ARDS is significant source of mortality as well as a drain on healthcare resources across the globe. We are committed to reaching our goal of saving lives by addressing the challenges of this complex disease," stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00067. BioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens. Normal levels of pGSN are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form, rhu-pGSN, helps immune cells fight infection and controls inflammation so it does not spread and cause organ damage. Rhu-pGSN is a non-antibiotic, host-directed, non-immunosuppressive treatment for inflammation due to both infectious and non-infectious causes. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, and neurologic disease. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need. The content above comes from the network. if any infringement, please contact us to modify.

Partnership supports execution of a large phase 2 global study to evaluate efficacy and safety of recombinant human plasma gelsolin (rhu-pGSN) for moderate-to-severe ARDS. NORTH BRUNSWICK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce a second partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS). This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases. Effectively Treating ARDS will Reduce Society’s Vulnerability to Global PandemicsAcute Respiratory Distress Syndrome (ARDS) is a condition that can develop as a severe complication of pneumonia, sepsis, or trauma resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system. Even with aggressive medical management, a substantial number of patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the US alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions. The mortality rate for ARDS is approximately 40%. The lack of effective therapies to treat ARDS and its associated high mortality driven by excess inflammation underscores the urgent need for an innovative therapy in this field. Plasma Gelsolin: A Multitasking Protein for a Complex Condition Plasma gelsolin holds immense promise as a therapeutic intervention for ARDS due to its multifaceted mechanism of action. Gelsolin has demonstrated the ability to: Modulate the activation of the NLRP3 inflammasome and generation of IL-1β-containing microparticlesFacilitate uptake and killing of microbial pathogens by innate immune cellsBind to and remove harmful inflammatory mediatorsRegulate macrophage phenotype to modulate inflammation Gelsolin is a naturally occurring human protein found in the bloodstream, which is depleted by counteracting the inflammatory process. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated with ARDS. "We are delighted that BARDA DRIVe has chosen to continue our partnership with this shared goal of addressing the challenges of ARDS by bringing plasma gelsolin therapy to patients," stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067. About BioAegisBioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens. Normal levels of pGSN are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form, rhu-pGSN, helps immune cells fight infection and controls inflammation so it does not spread and cause organ damage. Rhu-pGSN is a non-antibiotic, host-directed, non-immunosuppressive treatment for inflammation due to both infectious and non-infectious causes. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, and neurologic disease. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need. Investor Inquiries:Steven Cordovano203-952-6373scordovano@bioaegistx.com Media Inquiries:Christine Laganaclagana@bioaegistx.com This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.