Rhinitis, Allergic, Seasonal

NIH findings may lead to insights on pregnancy complications, adult health BETHESDA, Md., May 2, 2025 /PRNewswire-HISPANIC PR WIRE/ -- What: The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy. Researchers analyzed male and female placental samples from a larger study for differences in their methylation patterns, and found differences in gene activity between male and female placentas that may play a role in birthweight and adult diseases. The study identified 2,497 previously unreported DNA sites that had different methylation patterns for males and females. Of these and more than 2,500 sites that had also been identified by previous studies, 66.9% of large increases in methylation occurred in DNA from male placentas and 33.1% from female placentas. Increases in methylation in male placentas was linked with greater neonatal size whereas those in females was linked with greater placental size. Some increases in methylation found in male placentas were located near the CCDC6 gene. Lower activation of CCDC6 has been linked with preterm birth in previous studies. Higher methylation near the FNDC5 gene was associated with lower expression of the gene in male placentas but not in female placentas. FNDC5 is involved with the manufacture of irisin, which protects the placenta from damage by reactive oxygen molecules and insulin resistance (cells' difficulty in using insulin to lower blood sugar.) Lower irisin levels have been associated with the pregnancy-related high blood pressure disorder, known as preeclampsia. Variations in the genes ATP5MG and FAM83A, expressed in female placentas, have been associated with asthma, hay fever, eczema (dry, itchy, inflamed skin) and higher risk for breast cancer later in life. Genetic factors influence the health differences between males and females, from before birth to later in life. Male fetuses grow faster than female fetuses and their pregnancies are more likely to be complicated by such conditions as preeclampsia (a hypertensive disorder of pregnancy), failure to grow at an adequate rate, and preterm birth. They also are more likely to die in the year after birth. Dysfunction of the placenta underlies many pregnancy complications and is thought to set the stage for male and female health differences that occur later in life. Variations in methylation patterns are thought to underlie many of these differences. The study was conducted by Fasil Tekola-Ayele, Ph.D., of the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and colleagues at other institutions. It appears in Nature Communications. Who: Fasil Tekola-Ayele, Ph.D., is available for comment on this study. Reference Tekola-Ayele F, et al. Sex-differentiated placental methylation and gene expression regulation has implications for neonatal traits and adult diseases. Nature Communications. DOI: 10.1038/s41467-025-58128-3 (2025) SOURCE Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institutes of Health (NIH) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ALK (ALKB.DC / OMX: ALK B) today announced that its European regulatory filing for ITULAZAX® (tree pollen sublingual allergy immunotherapy tablet) for treatment of young children and adolescents aged five to 17 has been approved by the health authorities in 17 EU countries via a type II variation procedure. First market introductions are expected to follow in the coming months ahead of the 2025/2026 initiation season for new patients starting treatment on pollen allergy tablets. Executive Vice President of R&D, Henriette Mersebach (MD), says: “We are very pleased with the European health authorities' approval which allows us to provide this important treatment option to children and adolescents whose lives are impaired by uncontrolled tree pollen-induced respiratory allergy. Today’s approval marks another significant milestone in our continuous efforts to make our respiratory tablets available to all age groups in all relevant markets". ALK’s regulatory filing was based on data from the TT-06 clinical trial. TT-06 was a randomised, placebo-controlled Phase 3 trial involving 952 children and adolescents aged five to 17 with a clinical history of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch trees and other trees in the birch homologous group. The trial confirmed that the treatment was well tolerated and had a favourable safety profile. The peer-reviewed results were published in 2024 in the European Journal of Allergy and Clinical Immunology. The tree tablet, branded ITULAZAX® in Europe and ITULATEK® in Canada, has, until now, been approved by 22 countries for adult patients aged 18 to 65. Corresponding paediatric regulatory reviews are currently ongoing in Canada, Switzerland, and the UK. These reviews are expected to complete in 2025. The approval of ITULAZAX® for paediatric use marks the completion of ALK's decade-long development efforts, ensuring that five of the most common respiratory allergies (grass pollen, house dust mite, ragweed pollen, Japanese cedar pollen, and now tree pollen) are all covered by allergy immunotherapy tablets approved for children, adolescents, and adults in relevant markets. The approval is not expected to affect ALK’s financial outlook for 2025. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. ALK manufactures and markets allergy immunotherapy (‘AIT’) treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment Company release_08_25UK_230425_Itulazax_approval_children

CHENGDU, China, April 5, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") today announced that the prestigious medical journal Nature Medicine has published the results from the Phase III trial of its independently developed IL-4Rα antibody stapokibart, for the treatment of moderate-to-severe seasonal allergic rhinitis (SAR). The study, led by Professor Luo Zhang of Beijing Tongren Hospital, Capital Medical University, represents the world's first clinical report on an IL-4Rα-targeted biologic for SAR, underscoring Chinese scientists' pioneering role in allergic rhinitis innovation. The study demonstrated that stapokibart significantly alleviates clinical symptoms and improves quality of life in patients with moderate-to-severe SAR who remained inadequately controlled despite standard therapies. This breakthrough offers a transformative solution to a global health challenge, ushering in a new era of biologic treatments for allergic rhinitis and providing hope to hundreds of millions of patients worldwide. Rapid, potent and sustained control of nasal symptoms: Rapid relief of nasal obstruction：Compared to placebo group, patients in stapokibart group achieved significantly greater improvement in nasal congestion symptom at Day 2. By Day 7, 72% of patients reported clear nasal breathing, with the cumulative response rate rising to 86% at Week 2 and 94% at Week 4. Potent and sustained control of nasal symptoms：Stapokibart demonstrated a 2.7-point reduction in daily reflective total nasal symptom score (rTNSS) from baseline by Day 4, significantly greater than the improvement in the placebo group. Over the 2-week treatment period, stapokibart achieved a 3.6-point reduction in daily rTNSS from baseline, with a least squares (LS) mean difference of -1.3 points vs. placebo (the primary efficacy endpoint). Additionally, 62% of patients achieved mild or no symptom (defined as rTNSS ≤1 point for each symptom); Over the 4-week treatment period, the stapokibart group showed a 4.9-point reduction in daily rTNSS from baseline, with an LS mean difference of -1.7 points vs. placebo. The proportion of patients achieving mild or no nasal symptoms reached 84%. Sustained and significant improvement of ocular symptoms: Stapokibart demonstrated clinically significant reductions in the daily reflective Total Ocular Symptom Score (rTOSS) from baseline, with improvements of 2.6 points at week 2 and 3.7 points at week 4 respectively, both significantly superior to placebo. By Week 2, 62% of patients achieved mild or no ocular symptoms (defined as rTOSS ≤1 point for each symptom), increasing to 94% by Week 4. Significant reduction in levels of type 2 inflammatory biomarkers During the 4-week treatment period, the stapokibart group demonstrated significant reductions in total serum IgE levels and allergen-specific IgE (sIgE) levels against pollen allergens. Additionally, stapokibart reduced type 2 inflammatory biomarker levels in nasal secretions, including cystatin SN (CST1) and eotaxin-3, demonstrating its dual mechanism of action: targeting both the underlying etiology (type 2 inflammation) and symptomatic manifestations of allergic rhinitis. Safety Stapokibart demonstrated a favorable safety profile in patients with seasonal allergic rhinitis. The incidence of treatment-emergent adverse events (TEAEs) was comparable to placebo, and no serious adverse events (SAEs) were reported during the trial. The PHECDA trial pioneered targeted biologic therapy for allergic rhinitis. The results supported the approval of stapokibart—the world's first and only IL-4Rα monoclonal antibody for seasonal allergic rhinitis (SAR)— by China's National Medical Products Administration (NMPA) on February 7, 2025. This breakthrough provides a novel therapeutic option for patients with moderate-to-severe refractory SAR, solidifying Chinese clinical scientists' global leadership in allergic rhinitis research and setting a precedent for future clinical development. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED