Latest news with #BioAegisTherapeutics
Yahoo
17-06-2025
- Health
- Yahoo
BioAegis Therapeutics Receives FDA Fast Track Designation for Lead Product, Recombinant Human Gelsolin, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
NORTH BRUNSWICK, N.J., June 17, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN) for the treatment of acute respiratory distress syndrome (ARDS). The company's portfolio is built around gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function. What Fast Track Designation Means to BioAegis and PatientsThe FDA Fast Track program is designed to facilitate the development of new therapies for serious conditions with high unmet medical needs. Fast Track status enables more frequent interactions with the FDA, including rolling review of the marketing application, and eligibility for priority review, which can significantly accelerate time to market. For BioAegis, this designation highlights the therapeutic promise of rhu-pGSN and provides a clear regulatory pathway to expedite its development as a treatment for ARDS. ARDS is a life-threatening condition marked by severe pulmonary inflammation and fluid accumulation in the lungs. Even with aggressive medical management, 40% of ARDS 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 500,000 patients per year, or roughly 10% of all ICU admissions. With no effective pharmacological therapies currently available for ARDS and its high mortality rate driven by excessive inflammation, there is an urgent need for innovative treatments in this field. BioAegis is currently enrolling patients in a 600-patient global Phase 2b trial to evaluate the efficacy and safety of rhu-pGSN in moderate to severe ARDS (NCT05947955). As part of the Fast Track designation, rhu-pGSN may also be made available to patients through the FDA's Expanded Access or Compassionate Use program, offering a potential treatment option for those who are not eligible for clinical trials and have no alternative therapies. 'Receiving FDA Fast Track designation is a critical milestone for BioAegis and further validates the potential of gelsolin to address the urgent and unmet needs of ARDS patients. Despite the high mortality of ARDS and its major strain on our healthcare system, no approved treatments currently exist. Fast Track status brings us closer to delivering an effective therapy for this devastating condition,' states Susan Levinson, PhD., CEO of BioAegis Therapeutics. Gelsolin: A Multitasking Protein for Complex Inflammatory Conditions Gelsolin holds immense promise as a therapeutic intervention for serious acute and chronic conditions due to its multifaceted mechanism of action. In critical illness, gelsolin levels collapse, causing adverse outcomes. Supplementing gelsolin addresses this deficit directly—restoring immune balance while preserving host defense—and has been shown in both animals and humans to: Modulate the activation of the NLRP3 inflammasome. Enhance uptake and killing of microbial pathogens by innate immune cells. Bind to and remove harmful inflammatory mediators and toxic actin released from damaged cells. Regulate macrophage phenotype to modulate inflammation. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated many inflammatory diseases without suppressing immune function. About BioAegisBioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key regulatory component of the body's immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation. 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, neurologic disease, and frailty. BioAegis will also have U.S. biologics exclusivity and has recently filed new IP in areas of unmet need. BioAegis' lead product, rhu-pGSN, is currently being studied in a 600-patient global Phase 2 trial for patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). 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. Investor Inquiries:Steven Cordovano203-952-6373scordovano@ Media Inquiries:Christine Laganaclagana@ 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 Sie sich an, um Ihr Portfolio aufzurufen.
Associated Press
10-06-2025
- Health
- Associated Press
BioAegis Therapeutics Announces US Navy Contract to Support Phase 2 Study of Recombinant Human Gelsolin, for Inflammasome-Driven Decompression Sickness (DCS)
NORTH BRUNSWICK, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for acute and chronic inflammatory diseases, announces that it will conduct a Phase 2 study of rhu-pGSN for decompression sickness (DCS) under a contract awarded by the U.S. Navy's Office of Naval Research to the University of Maryland School of Medicine (UMSOM). This work is the culmination of an extended collaboration with Dr. Stephen Thom, Professor of Emergency Medicine at UMSOM. The Company's portfolio is built around gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function. Phase 2 Clinical Trial of Rhu-pGSN The study, 'Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers,' NCT06216366 is being conducted under a contract with the Office of Naval Research with the University of Maryland. It will investigate the use of rhu-pGSN as a pre- or post-exposure intervention in healthy trained SCUBA divers exposed to controlled hyperbaric conditions. The study is designed to assess the impact of rhu-pGSN on key inflammatory responses and microparticle production associated with decompression. Decompression sickness occurs when inert gas bubbles form in the bloodstream and tissues due to rapid pressure changes, triggering an inflammatory cascade. Previous studies have shown that individuals with DCS exhibit depleted levels of plasma gelsolin and elevated levels of microparticles that contain inflammatory cytokines. In animal models, supplementation with rhu-pGSN both prevented and mitigated DCS-related complications. This randomized, double-blind, placebo-controlled study will enroll healthy trained SCUBA divers at a single site and expose them to a standardized hyperbaric protocol (30 meters of seawater for 35 minutes). Participants will be randomized into three groups to receive either pre-exposure or post-exposure rhu-pGSN, or placebo. The study will assess a broad range of outcomes including plasma gelsolin levels, inflammatory markers like IL-1β, gas bubble formation, and well-being metrics. Dr. Thom states, 'If successful, this study could transform the way we manage decompression sickness by providing a portable, field-deployable treatment option. Reducing our reliance on hyperbaric chambers would greatly expand our ability to treat DCS in remote or operational environments, improving outcomes and readiness, a key goal for the Navy.' BioAegis and University of Maryland are co-applicants on a patent filing listing Dr. Thom as an inventor. Gelsolin: A Multitasking Protein for Complex Inflammatory Conditions Rhu-pGSN holds immense promise as a therapeutic intervention for serious acute and chronic conditions due to its multifaceted mechanism of action. In critical illness, gelsolin levels collapse, causing adverse outcomes. Supplementing gelsolin addresses this deficit directly, restoring immune balance while preserving host defense and rhu-pGSN has been shown in animal studies to: Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated many inflammatory diseases without suppressing immune function. About BioAegis BioAegis Therapeutics Inc. is a NJ-based clinical-stage private company whose mission is to capitalize on a key regulatory component of the body's immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation. 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, neurologic disease, and frailty. BioAegis will also have U.S. biologics exclusivity and has recently filed new IP in areas of unmet need. BioAegis' lead product, rhu-pGSN, is currently being studied in a 600-patient global Phase 2 trial for patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). 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. NCT05947955 Investor Inquiries: Steven Cordovano 203-952-6373 [email protected] Media Inquiries: Christine Lagana [email protected]
Yahoo
07-05-2025
- Business
- Yahoo
BioAegis Therapeutics Announces Site Activation and Patient Recruitment Underway in 13 Countries in Phase 2b Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Dis
BioAegis Therapeutics 600-patient study to assess efficacy of rhu-pGSN, an immune system regulator that interrupts the NLRP3 inflammasome and boosts macrophage clearance of pathogens. Results from this landmark study expected to inform therapeutic strategies beyond ARDS, positioning rhu-pGSN as a promising intervention across a spectrum of acute and chronic inflammatory diseases. NORTH BRUNSWICK, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for acute and chronic inflammatory diseases, announces that patient recruiting is underway across all 13 targeted countries for its Phase 2 study of rhu-pGSN for the treatment of ARDS. (NCT05947955). The Company's portfolio is built around gelsolin (GSN), a highly conserved and critical immune regulatory protein which controls dysfunctional inflammation without suppressing immune function. Large Global Phase 2 Clinical Trial of rhu-pGSN Underway The randomized, double-blind, placebo-controlled trial of rhu-pGSN added to standard of care will evaluate the efficacy (survival without organ failure on Day 28) of six doses of rhu-pGSN administered intravenously to hospitalized moderate-to-severe ARDS subjects (P/F ratio ≤150) caused by infection. It will also measure the safety and tolerability of treatment along with secondary outcomes. Sites are recruiting patients in 13 countries including US, Canada, UK and the EU (Belgium, France, Italy, Germany, Netherlands, Spain, and others). Enrollment is targeted for 600 subjects. 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. "We are excited with our significant progress in this important study. Focusing this study on the moderate to severe patient who will have severely depleted plasma gelsolin levels promises to address ARDS with a novel approach employing the protein whose role in the body is to balance the inflammation-healing axis,' stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis. Effectively Treating ARDS Will Alleviate Massive Healthcare Burden 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.
