Rhinovirus infection

LUND, Sweden, Nov. 7, 2023 /PRNewswire/ -- CEO Comment "The positive research results presented during the quarter contribute to us trusting our financial goals for 2026.. Sales in our own markets Sweden, UK and Iceland are doing very well, with a market share in Sweden that is one of the highest for several years. We are discussing constructive ways forward together with our current partners since sales outside of our own markets have been lower than expected. I am very pleased to see how the recent research findings have sparked an interest for Enzymatica and our technology from many different stakeholders around the worl," said Claus Egstrand, CEO, Enzymatica. Significant events during the quarter In August, the Medical University of Innsbruck, Austria, presented the findings from an in vitro study that explored the effect of ColdZyme on human cells infected with the influenza virus. The study shows that ColdZyme disrupts the infection cycle and restricts the spread of the virus to more cells. When ColdZyme was applied to infected cells, the viral load decreased by 99% compared with cells treated solely with saline solution. The researchers believe that ColdZyme would have a similar effect on other respiratory viruses. In September, the University of Kent (United Kingdom) presented the initial findings from an ongoing in vivo study where athletes use ColdZyme or a placebo for symptoms of upper respiratory tract infections. The results show that ColdZyme statistically significantly reduces the quantity of rhinovirus, the most common cause of the common cold. Moreover, individuals who used ColdZyme demonstrated statistically significantly fewer sore throat symptoms compared with individuals who used a placebo. The study, which is designed as a prospective, placebo-controlled, double-blind, and randomized trial, will be completed in the first half of 2024. Significant events after the quarter No significant events have been reported after the quarter. Other events during and after the quarter An abstract regarding the ongoing study at the University of Kent has been accepted for presentation at the 7th International Olympic Committee Conference on the Prevention Injury and Illness in Sport. The abstract will be also published in the British Journal of Sports Medicine. The company is engaged in discussions with its partners regarding the launch in China and Japan. In the light of the recent research findings, optimal product claims and classifications are being evaluated. The expansion of production capacity at the facility in Reykjavik has continued during the year and the facility is now ready to handle an extensive increase in capacity. Lower than expected sales outside of Enzymatica's own markets (Sweden, UK, Iceland) has prompted discussions with the current business partners to explore constructive ways forward. The full report is available on: This information is information that Enzymatica is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CET on November 7, 2023. For more information, please contact: Claus Egstrand, Chief Executive Officer, Enzymatica AB Phone: +44 7780 22 8385 | Email: [email protected] Stefan Olsson, Communication Manager, Enzymatica AB Phone: +46 708 55 11 85 | Email: [email protected] Enzymatica AB is headquartered in Lund, Sweden, and is listed on Nasdaq First North Growth Market. For more information, please visit . Enzymatica's Certified Adviser is Erik Penser Bank. The following files are available for download:

Researchers have developed a way of detecting the early onset of deadly infectious diseases using a test so ultrasensitive that it could someday revolutionize medical approaches to epidemics. The test is an electronic sensor contained within a computer chip. It employs nanoballs -- microscopic spherical clumps made of tinier particles of genetic material -- and combines that technology with advanced electronics. Rutgers researchers have developed a way of detecting the early onset of deadly infectious diseases using a test so ultrasensitive that it could someday revolutionize medical approaches to epidemics. The test, described in Science Advances, is an electronic sensor contained within a computer chip. It employs nanoballs -- microscopic spherical clumps made of tinier particles of genetic material, each of those with diameters 1,000 times smaller than the width of a human hair -- and combines that technology with advanced electronics. "During the COVID pandemic, one of the things that didn't exist but could have stemmed the spread of the virus was a low-cost diagnostic that could flag people known as the 'quiet infected' -- patients who don't know they are infected because they are not exhibiting symptoms," said Mehdi Javanmard, a professor in the Department of Electrical and Computer Engineering in the Rutgers School of Engineering and an author of the study. "In a pandemic, pinpointing an infection early with accuracy is the Holy Grail. Because once a person is showing symptoms -- sneezing and coughing -- it's too late. That person has probably infected 20 people." For the past 20 years, Javanmard has been developing biosensors -- devices that monitor and transmit information about a life process. During the COVID-19 pandemic, he became disheartened about the extent of infections and the extreme loss of life. He believed there had to be a way of using biosensors as a test to detect illness earlier. Working with Muhammad Tayyab, a Rutgers doctoral student and co-author of the study, Javanmard and research colleagues at the Karolinska Institute in Sweden and Stanford and Yale universities started brainstorming. "We thought: How is there a way where we can leverage our individual expertise to build something new?" Javanmard said. The biosensor developed by the team works through a series of steps. First, it zeroes in on a virus' characteristic sequence of nucleic acids -- naturally occurring chemical compounds that serve as the primary information-carrying molecules in a cell. Next, because it amplifies any nucleic acid sequence found in the sample, it makes many more copies, as many as 10,000. Then, it clumps those thousands of specks of nucleic acids into nanoballs that are "large" enough to be detected. The nanoballs are identified electrically when they are directed individually through minute channels containing electrodes on opposite sides. The process is akin to people walking single an airport security gate and being X-rayed one by one. "Our method involves taking the viral nucleic acid material and rolling it up into a ball of DNA that is large enough to be detected by a cell measurement device known as an electronic cytometer," Javanmard said. "As a result, we can flag the infection at its earliest stages when the concentration is still very low." The approach works in samples taken from blood and saliva and has been shown to detect early infections by several viruses, including the rhinovirus causing the common cold, and even bacterial infections such as tuberculosis. The technology, which has been miniaturized and is contained within a computer chip, is small enough to be portable and wearable. The most immediate use, once commercialized, is expected to be the test's efficacy in flagging viral infections at early stages. Ultimately, the technology also may be used to test bacteria-based illnesses as well as bacterial contamination found in food and water supplies, Javanmard said. "These pathogens can be devastating to the economy, to people's livelihoods, and to people's health," Javanmard said. "We should not stop preparing for this. We need to be creating the next generation of tools to stop them. And that's really what this technology is."

-- New $3.8 million DOD contract extension will fund non-clinical safety studies to support a three-month seasonal prophylaxis Phase 2b study in at-risk populations, comprising elderly individuals with comorbidities, including chronic lung diseases and diabetes. -- ENA Respiratory names new clinical leaders and consultants to accelerate and optimize its research and development program. SYDNEY, Australia, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Clinical-stage pharmaceutical company ENA Respiratory has been awarded an additional $3.8 million contract from the U.S. Department of Defense (DOD) to support ongoing research and development of INNA-051, a first-in-class, intranasal, innate immune modulator for the prevention of complications associated with respiratory viral infections in at-risk populations. The company also announced new clinical leadership and consultants as it plans for a seasonal prophylaxis Phase 2b study. The new funding adds to the $4.38 million initial DOD funding the company announced in January 2023, which has been used to implement INNA-051 manufacturing on a larger scale. The funds also supported the development of a dry powder formulation that is expected to provide long-term stability of at least 24 months at room temperature. The new funding will support the non-clinical toxicology and safety studies needed to enable a seasonal prophylaxis Phase 2b study to demonstrate the safety, tolerability, and efficacy of intranasal INNA-051 in preventing respiratory illness in people aged 65 or older. “Early studies validated the safety of INNA-051 and provided proof of pharmacology by accelerating virus clearance and boosting host defense responses against common respiratory viruses,” said Christophe Demaison, Ph.D., co-founder and CEO of ENA Respiratory. “We are grateful for the U.S. DOD support and look forward to continuing to study INNA-051 in preventing respiratory illnesses, especially in those at greatest risk of exposure, complications, or hospitalization.” The contract was awarded by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical in collaboration with the Defense Innovation Unit (DIU). ENA Respiratory Names Expanded Clinical Leadership The company also announced new leadership and consultants to accelerate and optimize its research and development program. Ruth Tal-Singer, Ph.D., joins as Medicine Development Leader to oversee all clinical development efforts. Previously, Dr. Tal-Singer was a Consultant and Board Member for ENA Respiratory. She is an internationally recognized scientist with extensive experience in molecular biology, immunology, and application of digital technology and in vivo disease models in clinical development. Most recently, she served as President and CEO of the COPD Foundation, where she launched the Foundation’s digital health, medical devices, and therapeutics development accelerator network, COPD360Net®, and championed its partnership with ENA Respiratory. Her efforts to ensure the patient voice is central to lung disease therapeutics development continue in her volunteer role as Chief Scientific Officer of the Global Allergy and Airways Patient Platform (GAAPP). Earlier in her career, she served in senior leadership roles at GSK R&D. Courtney Crim, M.D., joins as Clinical Consultant and acting Chief Medical Officer. He also serves as Clinical Associate Professor of Medicine in the Division of Pulmonary and Critical Care Medicine at the University of North Carolina in Chapel Hill. Previously, he was Group Director in Clinical Development in Respiratory Clinical Sciences at GSK, designing Phase 2-4 clinical trials. He has also served on the FDA Pulmonary and Allergy Drug Advisory Committee and presented drug approval submissions to U.S., European, and other regulatory agencies. Bruce Miller, Ph.D., joins as a Clinical Consultant with more than 30 years of experience developing therapies for COPD and other inflammatory-driven diseases. He has previously served in senior scientific roles at GSK, Johnson & Johnson, Rhone-Poulenc Rorer, and Sterling Winthrop Pharmaceuticals. Active in the industry, he previously served as co-chair of the COPD Foundation’s COPD Biomarker Qualification Consortium’s Fibrinogen Working Group, which was instrumental in gaining regulatory qualification for a biomarker as a drug development tool in COPD trials. “Our accomplished team brings decades of experience leading clinical research programs for respiratory diseases and successfully submitting new therapies for regulatory approvals in the U.S., Europe, and other regions,” said Dr. Demaison. “With these additions to our team, we are well-positioned to continue the clinical development of INNA-051 in the context of natural respiratory tract infections in individuals with increased risk of severe illness or exposure.” Effort sponsored by the U.S. Government under Other Transaction number HQ0845-23-9-0003 between ENA Respiratory Pty Ltd and the U.S. Government. The U.S. Government is authorized to reproduce and distribute reprints for Governmental purposes, notwithstanding any copyright notation thereon. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government. Notes to Editors If you would like to arrange an interview, please contact: Glenn Silver, FINN Partners, +1 973 818 8198, glenn.silver@finnpartners.com About ENA Respiratory ENA Respiratory is aiming to transform the prevention of complications associated with respiratory viral infections in populations at-risk of complications. The company is based in Melbourne and Sydney, Australia, and it has secured a Series A investment from Brandon Capital Partners’ managed funds, the Minderoo Foundation, and Uniseed. In 2022, ENA Respiratory partnered with the US-based COPD Foundation to accelerate the clinical development of INNA-051 in COPD through its access to patients, a global network of accredited centres, scientific expertise, and patient investigators. That year, the company was also the first in the Asia Pacific region to be selected to join BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and U.S. BARDA. In 2023, the company was additionally awarded a USD $4.38 million contract from the U.S. Department of Defense to support ongoing development of INNA-051. About INNA-051 INNA-051 is a potent innate immune TLR2/6 agonist. It is being developed for intranasal delivery to target the primary entry site of viral respiratory infections as most respiratory viruses, including SARS-CoV-2, Human Rhinovirus, RSV, and influenza, initially infect and replicate in nasal mucosa epithelial cells. By targeting protective host defense mechanisms that are virus agnostic and through its simple route of administration, INNA-051 has the potential to address a major unmet need in at-risk populations. It also has the potential to be rapidly deployed and complement vaccine and direct-acting antiviral efforts in the battle against current and future respiratory virus outbreaks, including COVID-19. In a Phase IIa influenza-challenge study, INNA-051 was found to accelerate virus clearance and boost host responses against influenza virus, including interferon responses. The human data confirmed pre-clinical data in human airway epithelial cells as well as rhinovirus, influenza, and COVID-19 animal infection models. INNA-051 is well-tolerated in humans at single and repeat doses. Key features of INNA-051 intranasal administration include minimal systemic bioavailability, durable immune response (supporting weekly administration), and compatibility with available vaccines and corticosteroids. Importantly, INNA-051 activity is not significantly affected by senescence (inflammaging), and its safety profile supports prophylaxis use. For more information, please visit https://enarespiratory.com