Eptinezumab-JJMR

The results come from the multiple IV dosing portion of the trial, coded Proceed.\n After Lundbeck scrapped one portion of its trial, the company\'s intravenous monoclonal antibody has met the main goal of a phase 2b migraine prevention study, with multiple doses of the experimental treatment tied to a change in monthly migraine days.While the pharma didn’t share the data behind the result, the company said the dose-finding trial demonstrated a statistically significant difference compared to placebo in the number of monthly migraine days (MMDs) reported over 12 weeks among 431 patients who hadn’t responded to past preventative treatments.The investigational antibody was also well tolerated, according to Lundbeck. The pharma plans to share data behind the results at an upcoming conference.Based on the findings, the Danish pharma plans on discussing phase 3 design options with regulators. “These data underline Lundbeck’s ambition to deliver the first PACAP targeting option in migraine prevention,” Johan Luthman, Ph.D., EVP and head of R&D at Lundbeck, said in a Feb. 12 release.“With its novel mechanism of action, it has the potential to become an important addition to the migraine treatment paradigm, furthering Lundbeck’s mission to improve outcomes for people living with severe migraine,” Luthman said.The results come from the multiple IV dosing portion of the trial, coded Proceed. The study was also examining multiple doses of bocunebart via injection, but Lundbeck stopped development in the delivery method last year after reviewing the study data. The company launched the trial in 2024, in part to determine the best route of administration for bocunebart (also known as Lu AG09222), an anti-PACAP antibody. The success of single IV administration for bocunebart had prompted Lundbeck to assess whether subcutaneous delivery was viable, but a prespecified interim futility analysis of the subcutaneous data put an end to that assessment.The subcutaneous method in migraines has proven challenging for other players, as well.A few years ago, Amgen reported no benefit over placebo for its monoclonal antibody targeting the PAC1 receptor, while Eli Lilly stopped development of its anti-PACAP antibody after phase 2.Elsewhere in the migraine prevention field, Lundbeck markets the infused drug Vyepti in the crowded CGRP inhibitor space. The drug, which is administered every three months, hit the scene in 2020 to challenge subcutaneous big pharma rivals in Amgen\'s Aimovig, Eli Lilly\'s Emgality and Teva\'s Ajovy.Last year, Vyepti pulled down $710 million worldwide, a 59% increase from 2024, according to a recent earnings report (PDF).

New six-month results from the Vyepti® (eptinezumab) 12-month, real-world INFUSE study presented at the 2026 Headache Cooperative of the Pacific (HCOP) Annual Conference, Ojai, California1 The INFUSE study includes adults with migraine who had failed at least one preventive anti-calcitonin gene–related peptide (aCGRP) treatment1 Clinically meaningful improvements reported across migraine frequency, responder rates and other patient-reported outcomes in adults switching to eptinezumab1 Jan. 30, 2026 -- H. Lundbeck A/S (Lundbeck) today announced six-month data from the 12-month, real-world INFUSE study, evaluating the effectiveness of Vyepti® (eptinezumab) in adults with migraine who had failed at least one preventive anti-calcitonin gene–related peptide (aCGRP) treatment, at any time point previously. The findings, presented at the 2026 Headache Cooperative of the Pacific (HCOP) Annual Conference in California, USA (30–31 January), show improvements across multiple patient-reported outcomes in patients switching to intravenous (IV) eptinezumab, despite high disease burden.1 Migraine is the third most prevalent disease globally, and although multiple preventive treatment options are available, many patients continue to experience high disease burden due to insufficient efficacy or tolerability issues. Literature to date indicates that switching between subcutaneous (SC) aCGRP preventive therapies results in modest and variable improvement,2-7 while evidence on the benefit of switching from SC or oral therapies to IV eptinezumab remains limited. "These real-world data strengthen our confidence in eptinezumab's ability to deliver meaningful improvements in migraine burden, not only in clinical trials, but in everyday clinical practice," said Johan Luthman, EVP and Head of Research & Development at Lundbeck. "INFUSE demonstrates that patients receiving eptinezumab report consistent reductions in migraine frequency and improvements in everyday functioning, even in participants who previously experienced limited benefit from preventive aCGRPs." The INFUSE study is an ongoing observational, prospective study in which people with migraine were recruited through two Vyepti® Infusion Network partners in the US. This study includes adults in whom ≥1 preventive aCGRP had failed due to a lack of effectiveness or side effects, with no specific time frame between treatments required, according to protocol. This analysis reports the findings in participants who successfully completed a full six months of treatment with eptinezumab (n=111).1 Safety data was not collected in the study, however reported via standard safety reporting channels. After two infusions of eptinezumab, 75.7% of participants reported an improvement (any level) in migraine status (95% CI: 66.9%, 82.7%), as measured by the Patient Global Impression of Change Scale (PGIC) with 44.1% reporting "much improved," or "very much improved" (95% CI: 35.3%-53.4%). 44.1% of participants (95% CI: 35.3%-53.4%) reported a ≥50% reduction in monthly headache days (MHDs), with a mean reduction of 6.8 MHDs (95% CI: 5.2-8.3) from a baseline of 20.0 MHDs. Additionally, 26.1% of participants achieved >75% reduction in MHD at Month 6 (95% CI: 18.9%-35.0%). Patients also reported an average increase of 6.3 additional "good days" per month (95% CI: 4.7-7.9) compared with baseline (10.0 days/month). Together these findings reflect notable reductions in migraine frequency and improvements in day-to-day functioning, suggesting a potential clinical benefit in considering eptinezumab earlier in the treatment pathway.1 Eptinezumab has been shown to be well tolerated across multiple clinical trials. The safety of eptinezumab has been evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. During the registrational trials, PROMISE-1 and PROMISE-2, the most common adverse reactions were nasopharyngitis and hypersensitivity. The INFUSE study is part of Lundbeck's broader real-world evidence program in migraine. Lundbeck is committed to raising the bar within migraine care, working tirelessly to advance the understanding and management of migraine, a complex and progressive neurological disease that continues to impose a substantial burden on millions of people worldwide. Across our portfolio, we strive to develop innovative therapies, generate meaningful real-world evidence and support healthcare professionals in delivering effective, patient-centered care. Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. Not only is headache painful, but migraine also imposes both a social and financial burden. Migraine has a profound impact on patient functioning including relationships with family/friends, leisure activities, household production and worker productivity.Migraine is one of the most prevalent neurological diseases for which medical treatment is sought and is considered the leading cause of disability for people under the age of 50 and the 2nd leading cause of disability worldwide.8,9 Repeated migraine attacks, and often the constant fear of the next one, damage family life, social life and work life. Furthermore, increased use of acute headache medication may lead to central sensitization and decreased effectiveness of acute medication. This results in a vicious cycle of increased number of headache days requiring further increased amounts of acute headache medication. Without proper preventive migraine management, this process results in worsening and chronification of migraine.10 The INFUSE study is a 12-month, prospective, observational study in the US, assessing real-world effectiveness of intravenous (IV) eptinezumab (100 mg or 300 mg) in adults with migraine who previously failed at least one preventive anti-CGRP. Data were collected digitally at baseline, Day 7, and Months 3, 6, 9 and 12 through participant-reported surveys. The primary outcome was percent of patients with "much" or "very much" improved on the 7-point PGIC scale ("very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse"). Secondary outcomes included monthly headache days and ≥50% reduction in monthly headache days (MIDAS-derived) and number of patient-defined "good days".1 Recruitment occurred via two eptinezumab Infusion Network partners, including ≥100 infusion centers, capturing outcomes during the course of routine clinical practice with minimal site involvement. Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was intentionally designed for IV administration. The efficacy and safety of eptinezumab was evaluated in two Phase 3 clinical trials (PROMISE-1 in episodic migraine11 and PROMISE-2 in chronic migraine),12 where eptinezumab met its primary endpoint of decrease in monthly migraine days (MMDs) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both 100 mg and 300 mg doses of eptinezumab as early as Day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. VYEPTI (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in more than 30 markets worldwide. Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn. References: Starling A et al. Poster Presentation: HCOP Annual Conference 2025 Jaimes A et al. Headache 2025; 65:619–630. Iannone LF et al. Cephalalgia 2023;43:3331024231160519 Overeem LH et al. Cephalalgia:3331024211048765 Romozzi M et al. Headache, 2025;65:342–352 Hong JB et al. J Headache Pain,2024; 25:90 Straube A et al. J Headache Pain, 2023;24:59 Steiner TJ, et al. J Headache Pain. 2018;19(1):17 Leonardi M, et al. J Headache Pain. 2005; 6(6):429– 440 Lipton RB, et al. J Neurol. 2023;270(12);5692–5710 Ashina M, et al. Cephalalgia. 2020;40(3):241-254 Lipton RB, et al. Neurology. 2020;94(13):e1365-e1377 The content above comes from the network. if any infringement, please contact us to modify.