Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine

The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Start Date13 Sep 2024

Sponsor / Collaborator

H. Lundbeck A/S

NCT06323928

/ RecruitingPhase 2

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 2 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Start Date01 Apr 2024

Sponsor / Collaborator

H. Lundbeck A/S

NCT05304910

/ CompletedPhase 1

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Properties of Lu AG09222 in Healthy Caucasian, Chinese and Japanese Subjects

The main goal of the study is to learn more about how the body absorbs and eliminates Lu AG09222 after a single dose is injected under the skin. Researchers will also investigate safety and tolerability effects of Lu AG09222 after administration.

Start Date18 Mar 2022

Sponsor / Collaborator

H. Lundbeck A/S

100 Clinical Results associated with ALD-1910

100 Translational Medicine associated with ALD-1910

100 Patents (Medical) associated with ALD-1910

Literatures (Medical) associated with ALD-1910

05 Sep 2024·New England Journal of Medicine

A Monoclonal Antibody to PACAP for Migraine Prevention

Article

Author: Löf, Elin ; Khodaie, Melanie ; Phul, Ravinder ; Florea, Ioana ; Ashina, Messoud

BACKGROUNDTargeting pituitary adenylate cyclase-activating polypeptide (PACAP) is a new avenue for treating migraine. The efficacy and safety of intravenous Lu AG09222, a humanized monoclonal antibody directed against the PACAP ligand, for migraine prevention are unclear.METHODSIn a phase 2, double-blind, randomized, placebo-controlled trial, we enrolled adult participants (18 to 65 years of age) with migraine for whom two to four previous preventive treatments had failed to provide a benefit. The trial included a 4-week treatment period and an 8-week follow-up period. Participants were randomly assigned in a 2:1:2 ratio to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo. The primary end point was the mean change from baseline in the number of migraine days per month, during weeks 1 through 4, in the Lu AG09222 750-mg group as compared with the placebo group.RESULTSOf 237 participants enrolled, 97 received 750 mg of Lu AG09222, 46 received 100 mg of Lu AG09222, and 94 received placebo. The mean number of baseline migraine days per month was 16.7 in the overall population, and the mean change from baseline over weeks 1 through 4 was -6.2 days in the Lu AG09222 750-mg group, as compared with -4.2 days in the placebo group (difference, -2.0 days; 95% confidence interval, -3.8 to -0.3; P = 0.02). Adverse events with a higher incidence in the Lu AG09222 750-mg group than in the placebo group during the 12-week observation period included coronavirus disease 2019 (7% vs. 3%), nasopharyngitis (7% vs. 4%), and fatigue (5% vs. 1%).CONCLUSIONSIn a phase 2 trial, a single intravenous infusion of 750 mg of Lu AG09222 showed superiority over placebo in reducing migraine frequency over the subsequent 4 weeks. (Funded by H. Lundbeck; HOPE ClinicalTrials.gov number, NCT05133323.).

02 Jan 2024·Expert Opinion on Emerging Drugs

Targeting the PACAP-38 pathway is an emerging therapeutic strategy for migraine prevention

Review

Author: Pellesi, Lanfranco ; Martelletti, Paolo ; Ashina, Messoud

INTRODUCTIONThe pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) has emerged as a key mediator of migraine pathogenesis. PACAP-38 and its receptors are predominantly distributed in arteries, sensory and parasympathetic neurons of the trigeminovascular system. Phase 2 trials have tested human monoclonal antibodies designed to bind and inhibit PACAP-38 and the pituitary adenylate cyclase-activating polypeptide type I (PAC₁) receptor for migraine prevention.AREAS COVEREDThis review focuses on the significance of the PACAP-38 pathway as a target in migraine prevention. English peer-reviewed articles were searched in PubMed, Scopus and ClinicalTrials.gov electronic databases.EXPERT OPINIONA PAC₁ receptor monoclonal antibody was not effective for preventing migraine in a proof-of-concept trial, paving the way for alternative strategies to be considered. Lu AG09222 is a humanized monoclonal antibody targeting PACAP-38 that was effective in preventing physiological responses of PACAP38 and reducing monthly migraine days in individuals with migraine. Further studies are necessary to elucidate the clinical utility, long-term safety and cost-effectiveness of therapies targeting the PACAP pathway.

19 Jun 2023·The journal of headache and pain

Correction: The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study.

Author: Ashina, Messoud ; Al-Khazali, Haidar Muhsen ; Amin, Faisal Mohammad ; Deligianni, Christina ; Karlsson, William Kristian ; Van de Casteele, Tom ; Christensen, Casper Emil ; Rasmussen, Nadja Bredo ; Granhall, Charlotte

News (Medical) associated with ALD-1910

11 Sep 2024

·synapse.patsnap.com

Monoclonal antibodies targeting PACAP peptide for the treatment of migraine

On September 4th, an article titled "A Monoclonal Antibody to PACAP for Migraine Prevention" was published in the latest issue of The New England Journal of Medicine. The article reported on Phase 2 clinical trial data for the use of the monoclonal antibody Lu AG09222ALD-1910 targeting pituitary adenylate cyclase-activating polypeptide (PACAP) in the treatment of migraine. It is reported that Lu AG09222(ALD-1910), a monoclonal antibody against PACAP, was originally developed by Lundbeck Seattle BioPharmaceuticals (LSBP). It functions by inhibiting the signaling pathways mediated by multiple G protein-coupled receptors (GPCRs) downstream of PACAP. In 2019, the Danish pharmaceutical company H. Lundbeck acquired LSBP and, consequently, took ownership of one of their products. Lundbeck continued to advance the clinical development of this product for migraine treatment. According to updated Phase 1 clinical trial data from 2023, healthy participants who received injections of Lu AG09222 + PACAP38 showed that Lu AG09222 inhibited PACAP38-induced dilation of head blood vessels and an increase in heart rate, and also reduced the associated headaches. These findings suggest that Lu AG09222 could be a potential treatment method for migraines and other PACAP-mediated diseases. In this Phase 2, double-blind, randomized, placebo-controlled trial reported by the New England Journal of Medicine (NEJM), subjects were adults aged 18 to 65 years old with migraines, who had not benefited from 2 to 4 previous preventive treatments. Participants were randomly assigned in a 2:1:2 ratio to receive a single dose infusion of 750 mg Lu AG09222, 100 mg Lu AG09222, or a placebo. The results showed that a total of 237 participants enrolled, with 97 receiving 750 mg Lu AG09222, 46 receiving 100 mg Lu AG09222, and 94 receiving the placebo. The average number of migraine days per month at baseline across the entire population was 16.7 days. In the 750 mg Lu AG09222 group, the average change from week 1 to 4 was a reduction of 6.2 days, compared to a reduction of 4.2 days in the placebo group (difference of 2.0 days; 95% confidence interval, -3.8 to -0.3; P=0.02). In terms of safety, during a 12-week observation period, the more common adverse events in the 750 mg Lu AG09222 group compared to the placebo group included COVID-19 (7% vs. 3%), nasopharyngitis (7% vs. 4%), and fatigue (5% vs. 1%). According to reports, migraine is a common chronic cerebrovascular neurological disorder that significantly impacts both individuals and society. It affects approximately one billion people worldwide and is characterized by recurrent, highly disabling episodes accompanied by severe headaches, nausea, vomiting, extreme sensitivity to light and sound, and various other physical, mental, and psychological signs and symptoms. Traditionally, the pathway involving CGRP (Calcitonin Gene-Related Peptide) and its receptors is considered one of the key pathways for migraine treatment, with several drugs already approved for marketing. In addition to this, targets like 5-HTR (5-Hydroxytryptamine Receptors) and COX (Cyclooxygenase) are also potential targets for clinical drug development. The article mentions PACAP (Pituitary Adenylate Cyclase-Activating Polypeptide) as an emerging potential target for migraine treatment. Besides the monoclonal antibodies mentioned in the article currently in Phase II clinical trials, Eli Lilly's development of Vipalanebart is also in Phase II clinical study stage. The differences in treating migraine with PACAP and CGRP are highlighted. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

04 Sep 2024

·www.drugs.com

Monoclonal Antibody Tops Placebo for Reducing Migraine Frequency

WEDNESDAY, Sept. 4, 2024 -- The humanized monoclonal antibody directed against the pituitary adenylate cyclase-activating polypeptide (PACAP) ligand, Lu AG09222, is better than placebo for reducing migraine frequency over four weeks, according to a study published in the Sept. 5 issue of the New England Journal of Medicine . Messoud Ashina, M.D., from Copenhagen University Hospital in Denmark, and colleagues conducted a phase 2, double-blind trial involving adults with migraine for whom two to four previous preventive treatments had failed to provide a benefit. The trial included a four-week treatment period and eight-week follow-up period. Participants were randomly assigned to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo (97, 46, and 94 individuals, respectively). The researchers found that in the overall population, the mean number of migraine days per month was 16.7, and the mean change from baseline over weeks 1 through 4 was −6.2 and −4.2 days in the Lu AG09222 750-mg group and placebo group, respectively (difference, −2.0 days). During the 12-week observation period, adverse events with a higher incidence in the Lu AG09222 750-mg group versus the placebo group included COVID-19 (7 versus 3 percent), nasopharyngitis (7 versus 4 percent), and fatigue (5 versus 1 percent). "This finding establishes proof of concept, supporting the notion that inhibition of PACAP signaling by Lu AG09222 represents a potentially effective mechanism for migraine prevention," the authors write. The study was partially funded by H. Lundbeck, which is developing Lu AG09222.

Phase 2Clinical Result

15 Jun 2022

·www.prnewswire.com

Migraine Market to Progress at a CAGR of 10.96% by 2032 | DelveInsight

The migraine market is expected to surge due to the increasing prevalence of the disease along with increasing awareness during the forecast period. Furthermore, the launch of various multiple-stage pipeline products will significantly revolutionize the migraine market dynamics. LAS VEGAS, June 15, 2022 /PRNewswire/ -- DelveInsight's Migraine Market Insights report includes a comprehensive understanding of current treatment practices, Migraine emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan. Key Takeaways from the Migraine Market Report As per DelveInsight analysis, the migraine market size in the 7MM was approximately USD 6.9 billion in 2021. As per the estimates, the total Migraine prevalent cases in the 7MM was approximately 118 million in 2021. Leading Migraine companies such as Lundbeck Seattle BioPharmaceutical, Eli Lilly and Company, Amgen, Novartis, Teva Pharmaceuticals, Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, Impel NeuroPharma, Zosano Pharma, Axsome Therapeutics, Aeon Biopharma Inc., Ionis Pharmaceuticals, Inc., Charleston Laboratories , and others are developing novel migraine drugs which can be available in the migraine market in the upcoming years. The migraine therapies in the pipeline include BHV-3500 (Zavegepant), Atogepant, INP104, Zolmitriptan transdermal, AXS-07, Lu AG09222, ABP-450, IONIS-PKKRx, Oral CL- H1T, LY-3451838, and others. The increased number of migraine cases and the emerging treatment are likely to contribute directly to the migraine market growth during the forecast period. Discover more about therapies set to grab major migraine market share @ Migraine Market Landscape Migraine Overview Migraine is the seventh most debilitating disease in the world (responsible for 2.9% of all years of life lost to disability/YLDs) and the leading cause of impairment among all neurological disorders. Migraine is classed as chronic or episodic based on the type of the attack and its frequency. Episodic migraine is defined as having 0–14 headache days per month, and chronic migraine is defined as having 15 or more headache days per month. Although migraine symptoms usually include severe throbbing recurring pain on one side of the head, one-third of migraine attacks are found to be affected on both sides. Among the most common migraine causes include stress, physical factors, food additives, and others. MRI and CT scans are mainly used for migraine diagnosis. Migraine Epidemiology Segmentation As per DelveInsight, there were approx 118 million Migraine prevalent cases in the 7MM in 2021. Among the EU5 countries, Germany had the highest migraine prevalence in 2021. The Migraine market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalence of Migraine Prevalent Cases of Migraine by severity Gender-specific Prevalence of Migraine Diagnosed Cases of Episodic and Chronic Migraine Download the report to understand which factors are driving migraine epidemiology trends @ Migraine Epidemiological Insights Migraine Treatment Market The key revenue-generating components of the acute migraine treatment market can be roughly characterized as triptans, NSAIDs, analgesics/opioids, and DHE (dihydroergotamine) or ergot alkaloids. Triptans continue to dominate the entire acute therapy landscape in terms of revenue generation. Some of the major migraine drugs (generics/branded) belonging to this class are eletriptan, almotriptan, sumatriptan, rizatriptan, zolmitriptan, and others. Moreover, preventive/prophylactic treatment is used to minimize the frequency, intensity, and duration of migraine attacks. Preventive migraine medicines approved by the FDA include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (botox), and topiramate; other drugs have demonstrated effectiveness but need FDA clearance. Apart from these, the other FDA approved drugs used for migraine treatment are Vyepti (Eptinezumab) (Lundbeck Seattle BioPharmaceutical), Emgality (Galcanezumab-gnlm) (Eli Lilly and Company), Aimovig (Amgen/Novartis), Ajovy (Teva Pharmaceuticals), Ubrelvy (Allergan), Rimegepant (Nurtec ODT) (Biohaven Pharmaceuticals), and others. To know more about migraine treatment, visit @ Migraine Medications Migraine Pipeline Therapies and Key Companies BHV-3500 (Zavegepant): Biohaven Pharmaceuticals Atogepant: AbbVie INP104: Impel NeuroPharma Zolmitriptan transdermal: Zosano Pharma AXS-07: Axsome Therapeutics Lu AG09222: Lundbeck ABP-450: Aeon Biopharma IONIS-PKKRx: Ionis Pharmaceuticals Oral CL- H1T: Charleston Laboratories LY-3451838: Eli Lilly and Company Learn more about the migraine medicine in clinical trials @ Migraine Treatment Migraine Market Dynamics The migraine treatment market looks promising as the market is emerging with newer treatments that have recently been approved by the FDA and are anticipated for approval in the coming years. A large number of clinical phase trials are being done to examine and evaluate promising investigational therapies and their much-awaited launch owing to a robust therapeutic treatment market and bolstering the treatment response as a whole. Moreover, the increasing disease prevalence and awareness will fuel the migraine market during the forecast period. However, some factors are hindering the growth of the migraine market. Despite the availability of standard treatment guidelines across regions and the well-entrenched presence of an array of available, mostly inexpensive options, current abortive and prophylactics, lack of biomarkers, and lack of therapies for pediatric patients exist as a high unmet need which is contrary to the popular perception. The therapies addressed in recent are not effective in all patients, have contraindications related to cardiovascular conditions in some patients, and are nonspecific or poorly tolerated in others. In addition, the undiagnosed, unreported cases and the unawareness about the disease remain the primary aspects that strive for the migraine market growth. Scope of the Migraine Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Migraine Companies: Lundbeck Seattle BioPharmaceutical, Eli Lilly and Company, Amgen, Novartis, Teva Pharmaceuticals, Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, Impel NeuroPharma, Zosano Pharma, Axsome Therapeutics, Aeon Biopharma Inc., Ionis Pharmaceuticals, Inc., Charleston Laboratories, and others Key Migraine Therapies: BHV-3500 (Zavegepant), Atogepant, INP104, Zolmitriptan transdermal, AXS-07, Lu AG09222, ABP-450, IONIS-PKKRx, Oral CL- H1T, LY-3451838, and others Therapeutic Assessment: Migraine current marketed and emerging therapies Migraine Market Dynamics: Migraine market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Migraine Market Access and Reimbursement Discover more about migraine drugs in development @ Migraine Clinical Trials Table of Contents Get in touch with our Business executive @ Healthcare Due Diligence Services Related Reports Migraine Epidemiology Migraine Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted Migraine epidemiology in the 7MM. Migraine Pipeline Migraine Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Migraine companies including Allergan, Biohaven Pharmaceuticals, Dr. Reddy's Labs, AbbVie, among others. Cluster Headache Market Cluster Headache Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cluster Headache companies including Eli Lilly and Company, Teva Pharmaceuticals, Novartis, among others. Cluster Headache Epidemiology Cluster Headache Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted Cluster Headache epidemiology in the 7MM. Cluster Headache Pipeline Cluster Headache Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cluster Headache companies including Eli Lilly and Company, Teva Pharmaceuticals, Novartis, among others. Other Trending Reports Glomerulonephritis Market | Lymphedema Market | Audiology Devices Market | Campylobacter Infections Market | Varicose Veins Market | Nasolabial Fold Market | Reactive Airway Disease Market | Scleritis Market | Contrast-Induced Nephropathy Market | Mucinous cystic neoplasms Market | Metastatic Uveal Melanoma Market | ICOS-Next Generation Immunotherapy Market | Herpes Simplex Market | Hepatitis C Market | Guillain-Barre Syndrome Market | Graft Versus Host Disease Market | Goitre Market Related Healthcare Blogs Neuromodulation Devices in Migraine Migraine Treatment Market Migraine Market Outlook About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Generic DrugImmunotherapy

100 Deals associated with ALD-1910

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Migraine Disorders	Phase 2	Czechia	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Denmark	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Slovakia	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Georgia	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	Poland	H. Lundbeck A/S	11 Nov 2021
Migraine Disorders	Phase 2	United States	H. Lundbeck A/S	11 Nov 2021
Rhinitis, Allergic, Seasonal	Phase 1	United Kingdom	H. Lundbeck A/S	01 Nov 2021
Headache	Phase 1	Denmark	H. Lundbeck A/S	15 Jul 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05133323 (Literature \| Pubmed \| N Engl J Med) Manual	Phase 2	Migraine Disorders	237	Lu AG09222 750 mg	(itnpaxmihk) = btskbqgdmt qnsxawifjc (stlxshwdlk ) View more	Positive	04 Sep 2024
				Lu AG09222 100 mg	-
NCT05133323 (CTgov)	Phase 2	Migraine Disorders	237	Lu AG09222 (Lu AG09222 High Dose)	wcgqotgqtd(vhvyabawrs) = sfycscubnc kpyyxrkhpq (piolczjnfq, gmvtsjzsub - vipqgsoayp) View more	-	08 Feb 2024
				Lu AG09222 (Lu AG09222 Low Dose)	wcgqotgqtd(vhvyabawrs) = sxvvbczoqp kpyyxrkhpq (piolczjnfq, hkyirajcje - mxmrvbhteg) View more
NCT04976309 (Pubmed \| J Headache Pain) Manual	Phase 1	Migraine Disorders	25	Lu AG09222 + PACAP38 + VIP	(fkcbukktjc) = qkpfcsdpyc pfgpbhhwww (egoddsvlcs, 3.96)	Positive	25 May 2023
				placebo + PACAP38 + VIP	(fkcbukktjc) = hrtgncuzsf pfgpbhhwww (egoddsvlcs, 13.0)
IAS2017	Not Applicable	-	-	VIP	mzmvpjkqpu(hsjnhqdvcm) = jrltbqvlkl jkitxkpgjj (qlydozzmpn )	-	01 Jan 2017
				PACAP	mzmvpjkqpu(hsjnhqdvcm) = jsciglchde jkitxkpgjj (qlydozzmpn )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis