PPTA Europe’s Post

We have selected host-directed therapeutic candidates from Edesa Biotech, Inc. and InflaRx N.V. for inclusion in a phase 2 platform clinical trial to address acute respiratory distress syndrome (ARDS). There are currently no approved therapeutics available to treat ARDS. ARDS is a life-threatening lung condition with multiple causes, including sepsis and severe pneumonia due to known or unknown health security threats such as pandemic influenza and COVID-19. Through the phase 2 study, BARDA will build a strong platform capability to investigate potential therapeutics that could address ARDS. Learn more: https://ow.ly/lSF250SnBFU

We are proud to announce that InflaRx N.V., a member of the Medical Countermeasures Coalition, has been awarded by the Biomedical Advanced Research and Development Authority (BARDA) inclusion in a phase 2 platform trial advancing therapeutics for Acute Respiratory Distress Syndrome (ARDS). This trial represents a significant milestone in developing life-saving treatments for ARDS. InflaRx's dedication to advancing medical countermeasures is evident as they continue work on vilobelimab, a first-in-class, anti-C5a monoclonal antibody that addresses severe inflammatory responses associated with ARDS. This study will provide crucial insights and pave the way for new therapeutic strategies in partnership with BARDA. #MedicalResearch #ARDS #InflaRx #ClinicalTrials #HealthcareInnovation #MedicalCountermeasures

Congratulations to these 2 companies! The specifics about the investigational antibody product candidates are here: Edesa Biotech, Inc.: Paridiprubart, an anti-TLR4 monoclonal antibody being developed as a treatment for hospitalized COVID-19 patients with ARDS. Paridiprubart targets the dysregulated innate immune response that can lead to an uncontrollable inflammatory response known as a cytokine storm. The therapeutic received a fast-track designation for the treatment of hospitalized COVID-19 patients from the FDA. InflaRx N.V.: GOHIBIC (vilobelimab), an anti-C5a monoclonal antibody authorized under FDA Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). The drug inhibits the tissue-damaging effects caused by the overactivation of neutrophils and other immune cells which can lead to disease progression to severe COVID-19.

Integrated Genomic and Social Network Analyses of Severe Acute Respiratory Syndrome Coronavirus 2 Transmission in the Healthcare Setting https://lnkd.in/e2YZ4RE9

Living with celiac disease? Explore your options. Participating in a research study offers numerous benefits beyond having access to investigative treatments, including getting actively involved in your own healthcare and helping others who also live with the condition. Right now, the ILLUMINATE-062 Study, a phase 2 clinical research study, is looking for adults ages 18+ with biopsy-confirmed celiac disease to evaluate an investigational drug designed to break down gluten in the stomach and improve control of celiac disease for people on a gluten-free diet. If you are still experiencing celiac disease symptoms, such as bloating, nausea, diarrhea, or abdominal pain, this study may be a fit for you. To participate, you must have been on a gluten-free diet for at least the past 12 months. Compensation and travel reimbursement may be available. To learn more, visit illuminatecd-cdf2.com.

Today the EMA rejects #Biogen/#Eisai application for the commercialization of Lecanemab for #Alzheimer's disease in Europe because they argue that the risks overweight the potential benefits. Right or wrong, this decision highlights the desperate need for #precisionmedicine in this field. Acknowledging the biological heterogeneity in AD is the key to unlock patient stratification and reach significant benefits with minimal risk.

Integrated Genomic and Social Network Analyses of Severe Acute Respiratory Syndrome Coronavirus 2 Transmission in the Healthcare Setting https://lnkd.in/e2YZ4RE9

Integrated Genomic and Social Network Analyses of Severe Acute Respiratory Syndrome Coronavirus 2 Transmission in the Healthcare Setting https://lnkd.in/e2YZ4RE9

Recently, the FDA unveiled the Rare Disease Innovation Hub – a new model that aims to foster collaboration and advance outcomes for patients with rare diseases. We're grateful for the FDA’s commitment to this area and with our like-minded vision to improve the patient journey, we recognize the critical need to break down barriers and co-create solutions to increase equitable care for all patients – no matter who they are or where they live. Working to enhance patient outcomes is at the core of what we do and why we are committed to activating meaningful change and empowering innovation across the rare disease care paradigm. The establishment of the Innovation Hub signifies a step forward toward optimizing care for patients, and ultimately creating a brighter future for the rare disease community. Read the FDA’s full statement: https://lnkd.in/eT3ZEEge

“We understand chronic HBV profoundly impacts the quality of life for people living with the disease, and we are excited to share our ongoing research efforts with the overall goal of working towards a functional cure.” For #HCPs: It’s an important year for #TeamBarinthus at the EASL | The Home of Hepatology 2024 Congress, as we prepare to present two clinical data updates on our lead #hepatitisB asset, VTP-300. These data underscore our commitment to improving outcomes for people with #HepB, providing hope for a potential functional cure. Read more details about our poster and oral sessions here: https://lnkd.in/eVgQrZ8s #EASL2024 #liverdisease #HBV #innovation