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Bioelectronic medicine researchers at the Feinstein Institutes for Medical Research, in collaboration with GE Research, publish a paper in the journal Brain Stimulation MANHASSET, N.Y.--(BUSINESS WIRE)-- We’ve all seen ultrasound images from glowing moms-to-be; now, researchers at The Feinstein Institutes for Medical Research, in collaboration with GE Research, have harnessed ultrasound technology to non-invasively reduce inflammation in the body. Results from human studies published in the journal Brain Stimulation point to the possibility of using bioelectronic medicine and neuromodulation to treat inflammatory diseases traditionally treated only with drugs. This press release features multimedia. View the full release here: Drs. Sangeeta Chavan (left) and Stavros Zanos (right) helped lead the new study which published in the journal Brain Stimulation. (Credit: Feinstein Institutes) Led by Feinstein Institutes’ Sangeeta S. Chavan, PhD, and Stavros Zanos, MD, PhD, along with GE Research’s Christopher Puleo, PhD, senior principal engineer and Jeff Ashe, MS, principal engineer in biomedical electronics, delivered spleen-focused ultrasound stimulation (FUS) or sham stimulation, to 70 healthy participants. Through careful blood analyses and measurements, they investigated the levels of endotoxin-induced tumor necrosis factor (TNF), an inflammatory protein that is released by white blood cells and circulates in the bloodstream. They found that spleen FUS has an anti-inflammatory effect, lowering TNF production from blood cells for more than 2 hours, with TNF returning to baseline levels by 24 hours after stimulation; sham stimulation has no effect on TNF production. “From diabetes and obesity to cardiovascular diseases and cancer, inflammation is a major pathogenic mechanism in many diseases,” said Dr. Zanos, associate professor at the Feinstein Institutes’ Institute of Bioelectronic Medicine. “These first-in-human results are exciting because they demonstrate the potential ultrasound stimulation therapy holds to treat diseases, non-invasively, with existing technology.” Preclinical research previously conducted by the Feinstein Institutes and others has shown that FUS targeting the spleen activates anti-inflammatory responses; this new study demonstrates these effects for the first time in humans. In 2021, the Feinstein Institutes and GE Research team showed the anti-inflammatory effects of liver-focused ultrasound on obesity in preclinical models. In 2022, Drs. Chavan and Zanos, along with GE Research and other collaborators, showed the ability of ultrasound to reverse diabetes in preclinical studies. “The idea that we can use non-invasive ultrasound stimulation rather than drugs to treat inflammatory diseases is exciting,” said Dr. Chavan, professor at the Institute of Bioelectronic Medicine at the Feinstein Institutes. “Building off decades of research, these results in humans help set the stage for more clinical studies that may one day lead to additional therapies for patients in need of care, beyond traditional pharmaceuticals.” Our body’s immune response to infection and disease is controlled through neural mechanisms mediated via the vagus nerve. Discovered in the lab of Kevin J. Tracey, MD, the Feinstein Institutes’ president and CEO, they dubbed this communication pathway the “inflammatory reflex,” which helped create the field of bioelectronic medicine. “We are at a tipping point because it is increasingly becoming clear that new technology, new devices and new stimulation can treat inflammatory diseases,” said Dr. Tracey, Karches Family Distinguished Chair in Medical Research. “Drs. Chavan and Zanos’ work with GE Research is a major advance in the field of bioelectronic medicine.” The Feinstein Institutes is the global scientific home of bioelectronic medicine, which combines molecular medicine, neuroscience and biomedical engineering. At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury. Built on years of research in molecular mechanisms of disease and the link between the nervous and immune systems, Feinstein Institutes researchers discover neural targets that can be activated or inhibited with neuromodulation devices, like vagus nerve implants or ultrasound technologies, to control the body's immune response and inflammation. If inflammation is successfully controlled, diseases – such as arthritis, pulmonary hypertension, Crohn’s disease, inflammatory bowel diseases, diabetes, cancer and autoimmune diseases – can be treated more effectively. About the Feinstein Institutes The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit and follow us on LinkedIn.

POLB 001 LPS human challenge clinical trial successfully completed No serious adverse events reported Results of full data analysis expected in Q2 2023 LONDON, UK / ACCESSWIRE / December 12, 2022 / Poolbeg Pharma (AIM:POLB)(OTCQB:POLBF) 'Poolbeg' or the 'Company'), a leading infectious disease focused biopharmaceutical company, announces that, further to its announcement in July 2022, it has now received the initial results having completed the Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a viral strain agnostic, small molecule immunomodulator being developed to address the unmet medical need for severe influenza. Key highlights from the study: · No further clinical activity is required to complete the objectives of the trial, bringing the recruitment and clinical phase to a close on schedule · No serious adverse events reported. POLB 001 was found to be safe and well tolerated · Data analysis has commenced and full data read-out is expected in Q2 2023 · The comprehensive dataset is expected to facilitate progression of the product to the next clinical phase for potential partners This LPS challenge trial was designed to evaluate the effect of POLB 001 on inflammatory responses in 36 healthy volunteers between 18 and 55 years of age following an intradermal and an intravenous LPS challenge. LPS acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases. POLB 001 is a unique potential treatment for viruses such as severe influenza as it is strain agnostic, unlike other flu treatments and prophylactics. This means that it can be effective regardless of which strain of influenza is dominant in any particular season or geography. As a shelf-stable, oral drug it could also be ideal as a stockpiling candidate for both seasonal outbreaks and pandemic preparedness. Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: "We have completed our first trial on schedule, achieving a key milestone for Poolbeg, thanks to the committed efforts of the team. We are actively planning the next steps for POLB 001 and are engaging with industry on potential partnering opportunities. "The threat of influenza shouldn't be underestimated. Cases are on the rise - the WHO estimates that there are 3-5 million severe influenza cases globally per year, with real pandemic potential. Severe influenza can also lead to other major complications such as pneumonia and stroke. There is a significant unmet need for severe influenza treatments, so we eagerly anticipate the full results of this study next year." Matthijs Moerland, PhD, Principal Investigator at CHDR, said: "LPS human challenge trials are a highly reliable way of measuring the efficacy of anti-inflammatory drugs and these initial data are an important first step. We are pleased to be involved in the development of a potential treatment for such an unmet need as severe influenza and we look forward to the vital insights that the full analysis will bring." -Ends- Enquiries Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O'Connell, CFO +44 (0) 207 183 1499 finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM) +44 (0) 207 220 0500 Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher +44 (0) 207 496 3000 J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist +353 (0) 1 679 6363 Optimum Strategic Communications Mary Clark, Nick Bastin, Manel Mateus, Vici Rabbetts +44 (0) 208 078 4357 poolbeg@optimumcomms.com About Poolbeg Pharma Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in prevalent and emerging infectious diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal. The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025. With its initial assets from hVIVO plc (formerly Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has completed its LPS human challenge trial with full data read-out expected in Q2 2023; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an Oral Vaccine Platform and is progressing two Artificial Intelligence (AI) Programmes to accelerate the power of its human challenge model data and biobank, with results from the first programme expected by year end. For more information, please go to or follow us on Twitter and LinkedIn @PoolbegPharma. Further detail on POLB 001 This trial is a randomised, double-blind, placebo-controlled, multiple dose, LPS human challenge trial in 36 healthy volunteers to assess the potential efficacy of POLB 001 in treating the hyperinflammatory responses associated with severe influenza. As part of the trial, researchers stimulated the immune systems of healthy volunteers with LPS across three cohorts. LPS triggers a robust immune response and acts as a surrogate for the hyperinflammatory effects associated with severe influenza infection, as well as other diseases. Each cohort received escalating doses of POLB 001 to evaluate its effectiveness in suppressing the body's harmful inflammatory response to both intradermal (a shallow injection) and intravenous (an injection in a vein) administered LPS, which will produce a broad-ranging dataset. Given POLB 001's mode of action, it is viral strain agnostic as it treats the body's reaction to infection rather than targeting the virus directly and, as such, POLB 001 is unaffected by the seasonal variants of influenza that arise each year which is a significant advantage over influenza treatments available on the market. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment. POLB 001 has patent protection until 2038 and is a shelf-stable oral drug which makes it ideal as a stockpiling candidate for both seasonal outbreaks and pandemic preparedness. POLB 001 also has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation (cytokine storm). This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage which is linked with many diseases. POLB 001 has the potential to block this by interrupting the positive feedback loop of inflammatory mediators. Poolbeg is currently investigating new potential uses and in due course hopes to expand its IP around this asset to cover new disease areas thereby increasing the value of the asset. The data collected in the previous Phase I study demonstrated that POLB 001 administration produces a potent and long-lasting inhibition of p38 MAP Kinase activity in humans. The study showed that after administration of single doses up to 600 mg and repeated doses up to 150 mg there were neither serious nor limiting adverse events to POLB 001, and that after a twice daily dose of 150mg an inhibition of LPS-induced TNFα of between 70% and 90% was achieved. About Influenza Influenza is a viral pathogen that infects approximately one-eighth of the world's population each year, an estimated 1 billion people infected globally, attacking the respiratory system leading to between 5 and 10 million hospitalisations and as many as 500,000 influenza related deaths. Survivors of severe influenza can suffer organ damage, leading to chronic and life-changing injuries. Complications include a 6-fold increased risk of heart attack, an 8-fold increased risk of Pneumonia, and an 8-fold increased risk of stroke. This leads to an enormous compound cost of treatment - influenza contributes to an estimated economic burden of $11.2bn every year in the US alone. This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: Poolbeg Pharma PLC View source version on accesswire.com: