Latest news with #phase3
Medscape
4 days ago
- General
- Medscape
Eptinezumab for Episodic Cluster Headache Prevention
Compared with placebo, eptinezumab failed to significantly reduce the number of episodic cluster headache (ECH) attacks but showed higher responder rates and improved quality-of-life measures. METHODOLOGY: Eptinezumab, an anti–calcitonin gene-related peptide monoclonal antibody, was evaluated for the treatment of ECH. This phase 3, double-blind, placebo-controlled trial (ALLEVIATE) was conducted across 64 sites in 18 countries from December 2020 to October 2023 and screened 628 adults with ECH. A total of 231 adults (aged 18-75 years; mean age, 44 years; 78% men) meeting the criteria (a history of ECH for 1 or more years and seven or more CH attacks during screening) were randomly assigned to receive either eptinezumab 400 mg (n = 113) or placebo (n = 118) via intravenous infusion. After the 4-week placebo-controlled phase, participants who received placebo transitioned to delayed-start active treatment for an additional 4 weeks, followed by 12 weeks of observation and an 8-week safety follow-up. The primary outcome was the change from baseline in the number of weekly attacks (weeks 1-2), assessed via a daily electronic diary; secondary outcomes included responder rates of 50% or greater/75% or greater; pain severity; change in disease status, assessed using the Patient Global Impression of Change (PGIC); quality of life, assessed using the Sleep Impact Scale; participant well-being, assessed using the EQ-5D-5L; and self-rated productivity, assessed using the Work Productivity and Activity Impairment. TAKEAWAY: No significant reduction in the number of weekly attacks were observed with eptinezumab vs placebo during weeks 1 and 2 (least-square mean difference, 0.7; P = .50). = .50). A higher proportion of eptinezumab-treated participants achieved 50% or greater response than placebo-treated participants over week 2 (50.9% vs 37.3%; odds ratio [OR], 1.77; P = .04), week 3 (62.5% vs 43.8%; OR, 2.26; P = .004), and week 4 (66.7% vs 50.5%; OR, 2.14; P = .009). = .04), week 3 (62.5% vs 43.8%; OR, 2.26; = .004), and week 4 (66.7% vs 50.5%; OR, 2.14; = .009). Compared with placebo, eptinezumab demonstrated improvements for 75% or greater responder rates by week 4 (35.5% vs 52.0%; OR, 1.98; P = .02). = .02). Numerically greater improvements were observed with eptinezumab than with placebo in terms of PGIC scores, EQ-5D-5L visual analog scale scores (mean difference, 7.8 points; P = .02), and sleep/activity metrics. = .02), and sleep/activity metrics. Treatment-emergent adverse events were similar between eptinezumab and placebo (25.0% and 26.5%, respectively), confirming tolerability. IN PRACTICE: "Among adults with episodic cluster headache, eptinezumab did not significantly reduce the number of attacks vs placebo, although it was associated with numerically higher responder rates and improvements in average daily pain and patient-reported outcomes. Eptinezumab was generally well tolerated," the authors of the study wrote. SOURCE: This study was led by Rigmor H. Jensen, Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark. It was published online on May 19 in JAMA Neurology . LIMITATIONS: T he study's generalisability may be limited due to the predominantly male (78%) and European population. Early termination due to futility reduced the sample size, although the cohort remained sufficient for the primary analysis. The 4-week placebo-controlled period was too brief to assess the long-term efficacy, unlike the 12-week regimens used for migraine prevention. DISCLOSURES: This trial was sponsored and funded by H. Lundbeck A/S, including medical writing support. Jensen reported receiving grants from Københavns Universitet, Lundbeck Pharma, Novo Nordisk, and Lundbeck Foundation paid to the institution during the conduct of the study. Additional disclosures are noted in the original article.
Medscape
22-05-2025
- Health
- Medscape
Secukinumab Cuts Chronic Pain in Hidradenitis Suppurativa
Compared with placebo, secukinumab demonstrated superior pain reduction in moderate to severe hidradenitis suppurativa in two phase 3 trials. Improvements in pain were sustained through week 52 and were associated with better quality of life outcomes. METHODOLOGY: Researchers analysed 1084 patients with moderate to severe hidradenitis suppurativa from two phase 3 trials (SUNSHINE and SUNRISE) and randomly assigned them to receive secukinumab 300 mg subcutaneously every 2 weeks (SECQ2W) or every 4 weeks (SECQ4W) or placebo until week 16. At week 16, patients randomly assigned to receive placebo switched to receive SECQ2W (placebo-SECQ2W) or SECQ4W (placebo-SECQ4W) until week 52, whereas those originally randomly assigned to receive SECQ2W or SECQ4W continued this treatment until week 52. Pain was assessed using the Patient's Global Assessment of Skin Pain on a continuous numeric rating scale (NRS) through week 52; the severity of pain was categorised into quartiles on the basis of baseline scores (NRS ≤ 3.3, NRS > 3.3 to ≤ 5.4, NRS > 5.4 to ≤ 7.2, and NRS > 7.2). This post hoc analysis of pooled data from the two trials evaluated the effect of secukinumab on multiple aspects of pain and in different subgroups of patients with hidradenitis suppurativa. TAKEAWAY: At week 16, a greater mean absolute change from baseline in skin pain was observed with secukinumab treatment (SECQ2W: mean difference, −1.35; SECQ4W: mean difference, −1.05) than with placebo (mean difference, −0.47). Reductions in skin pain in the secukinumab groups at week 16 were sustained, with a trend for improvement through week 52. Similar improvements were observed in placebo-SECQ2W and placebo-SECQ4W groups. Among patients with severe baseline pain (NRS > 7.2), 20.0% in the SECQ2W group and 12.7% in the SECQ4W group achieved significant pain reduction (NRS ≤ 3.3) at week 16. Patients achieving lower pain scores (NRS ≤ 3.3) experienced better quality of life outcomes. In the secukinumab groups, the proportion of patients requiring pain medication decreased at weeks 16 and 52 compared with baseline. IN PRACTICE: "This post hoc analysis of the SUNSHINE and SUNRISE phase 3 trials highlights the benefits of secukinumab in reducing skin pain in patients with moderate to severe HS [hidradenitis suppurativa], seen within a few weeks of treatment initiation, and sustained, with a trend for improvement, through week 52," the authors wrote. "Importantly, improvements in disease-related pain were associated with improvements in QoL [quality of life] of patients, as well as a decrease in the proportion of patients taking pain medication," they added. SOURCE: This study was led by John R. Ingram, Department of Dermatology & Academic Wound Healing, Division of Infection and Immunity, Cardiff University, Cardiff, Wales. It was published online on May 15, 2025, in Dermatology and Therapy . LIMITATIONS: Changes in skin pain observed may have been influenced by the use of concomitant medications and cannot be fully attributed to the study treatment alone. The cutoffs used for assessing skin pain categories were based on baseline NRS quartiles due to the absence of validated cutoffs for the hidradenitis suppurativa population. Additionally, the study population predominantly consisted of self-reported White participants, with a relatively low proportion of Black patients potentially limiting the generalisability of the findings to the broader global population. DISCLOSURES: This study was funded by Novartis Pharma AG, Basel, Switzerland. One author declared being an employee and stockholder at Novartis Ireland Limited, Dublin, Ireland. Four authors declared being employees of Novartis Pharma AG, Basel, Switzerland. One author declared being an employee of Novartis Pharmaceuticals, East Hanover, New Jersey, United States, at the time of the study. Several authors reported receiving consulting fees and having other ties with various sources.
Korea Herald
30-04-2025
- Automotive
- Korea Herald
LG Energy Solution Releases 2025 First-Quarter Financial Results
SEOUL, South Korea, April 30, 2025 /PRNewswire/ -- LG Energy Solution (KRX: 373220) today announced its first-quarter earnings for 2025, turning a profit through rigorous cost-cutting efforts. The company posted consolidated revenue of KRW 6.3 trillion, a 2.9 percent decrease quarter-on-quarter and 2.2 percent increase year-on-year. The operating profit was KRW 375 billion with an EBITDA [1] margin of 20 percent, marking a turn around to profitability. The operating profit includes the IRA tax credit amount of KRW 458 billion. "In the first quarter, we demonstrated solid shipments to North America and for newly launched EV models. However, as automakers continued their conservative approach to inventory management, our quarterly revenue declined compared to the last quarter," said Chang Sil Lee, CFO of LG Energy Solution. "Nevertheless, we successfully returned to profitability in the first quarter as our efforts to reduce material costs and enhance cost efficiency came to fruition, with one-off items reflected in the previous quarter no longer playing base effect into Q1 profit," Lee added. In the first quarter, LG Energy Solution has reallocated its production capacity in North America to better respond to market demands and address ongoing uncertainties. Namely, the company put the construction of its ESS battery plant in Arizona on hold and instead decided to first utilize the existing production capacity at its plant in Michigan, aiming to start producing LFP (lithium, iron, phosphate) batteries for ESS this year, a year earlier than planned. Also, the company is in the process of acquiring the GM JV phase 3 in Michigan, which would significantly expand its footprint in North America. This move will also maximize the utilization of investments already undertaken by minimizing the facility's downtime. Alongside this strategic adjustment, LG Energy Solution continued to make notable achievements in both the EV and ESS businesses based on its strong product competitiveness. The company successfully expanded its customer portfolio for 46-Series cylindrical batteries to legacy automakers by securing a new 10GWh (annual) order from an established automaker in North America. It also won contracts from Polska Grupa Energetyczna (PGE) for grid-scale ESS batteries in Europe and Delta Electronics for residential ESS batteries (4GWh) in the U.S. The company also ventured into new applications, including solar EVs and offshore wind farms, as well as establishing its first European battery recycling joint venture facility with Derichebourg in France, which will establish 20,000 tons of annual preprocessing capacity to meet the EU's battery recycling regulations and secure a metal supply chain. Moving forward, as regulatory transitions such as U.S. tariffs and the EU's industrial action plan for the automotive sector are expected to affect the battery industry broadly, LG Energy Solution will concentrate on streamlining operations and reducing costs this year, while actively pursuing strategic business opportunities. It will focus on indispensable investments and proactively adjust the scale and speed of capacity expansion in response to changing market demands. It will also take a cautious approach to managing inventory for EV batteries, while accelerating the revenue expansion in its ESS business, which holds relatively higher growth potential. At the same time, LG Energy Solution will continue to cultivate strategic business opportunities by continuing to secure future demands from its key customers with new products, including 46-Series cylindrical batteries. Simultaneously, it will proactively discover new applications for its cylindrical batteries, such as humanoid robots and drones. To mitigate the impact of tariffs, the company will promote the local production of raw materials by collaborating with material companies entering North America. It will also accelerate the development and adoption of new technologies, such as dry electrodes, to lower production costs. # # # About LG Energy Solution LG Energy Solution (KRX: 373220), a split-off from LG Chem, is a leading global manufacturer of lithium-ion batteries for electric vehicles, mobility, IT, and energy storage systems. With 30 years of experience in revolutionary battery technology and extensive research and development (R&D), the company is the top battery-related patent holder in the world with over 69,600 patents. Its robust global network, which spans North America, Europe, and Asia, includes battery manufacturing facilities established through joint ventures with major automakers. Committed to building sustainable battery ecosystem, LG Energy Solution aims to achieve carbon neutrality across its value chain by 2050, while embodying the value of shared growth and promoting diverse and inclusive corporate culture. To learn more about LG Energy Solution's ideas and innovations, visit
