Lu AG09222 / Lundbeck - LARVOL DELTA

PROCEED: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - P2 | N=898 | Recruiting | Sponsor: H. Lundbeck A/S | N=498 ➔ 898 | Trial completion date: Sep 2025 ➔ Apr 2026 | Trial primary completion date: Jul 2025 ➔ Feb 2026

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Following a planned interim analysis in the PROCEED trial Lundbeck expands the dose finding to intravenous administration of Lu AG09222 in migraine prevention (PharmiWeb) - "Lundbeck A/S (Lundbeck) is announcing reaching 75% recruitment target in the SC dose-finding part (Part A) in the phase IIb PROCEED trial, that explores dose and route of administration of the anti-PACAP mAb Lu AG09222....The PROCEED trial is expected to be completed in the first half of 2026 with planned pivotal phase III initiation in second half of 2026."

Enrollment status • New P3 trial • Trial completion date • Migraine

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: H. Lundbeck A/S | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

A Monoclonal Antibody to PACAP for Migraine Prevention. (PubMed, N Engl J Med) - P2 | "In 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.)."

Clinical • Journal • CNS Disorders • Fatigue • Infectious Disease • Migraine • Novel Coronavirus Disease • Pain • Respiratory Diseases • ADCYAP1

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: H. Lundbeck A/S

New P1 trial • CNS Disorders • Migraine • Pain

PROCEED: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - P2 | N=498 | Recruiting | Sponsor: H. Lundbeck A/S | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

PROCEED: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - P2 | N=498 | Not yet recruiting | Sponsor: H. Lundbeck A/S

New P2 trial • CNS Disorders • Migraine • Pain

Lundbeck’s progresses first-in-class therapy for migraine prevention (The Pharma Letter) - "Danish CNS specialist Lundbeck...today announced the advancement of the clinical development of for migraine prevention with the initiation of PROCEED, a randomized, double-blind, Phase IIb, dose-finding trial to assess efficacy and safety of multiple subcutaneously administered doses. The PROCEED trial builds on the positive results of the HOPE Phase IIa proof-of-concept trial demonstrating efficacy of intravenously administered Lu AG09222..."

New P3 trial • CNS Disorders • Migraine • Pain

Targeting the PACAP-38 pathway is an emerging therapeutic strategy for migraine prevention. (PubMed, Expert Opin Emerg Drugs) - "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."

Journal • Review • CNS Disorders • Migraine • Pain • ADCYAP1

From CGRP to PACAP, VIP, and Beyond: Unraveling the Next Chapters in Migraine Treatment. (PubMed, Cells) - "Clinical studies have demonstrated the significance of PACAP in migraine pathophysiology; however, a few clinical trials remain inconclusive: the pituitary adenylate cyclase-activating peptide 1 receptor mAb, AMG 301 showed no benefit for migraine prevention, while the PACAP ligand mAb, Lu AG09222 significantly reduced the number of monthly migraine days over placebo in a phase 2 clinical trial. In light of recent advances in PACAP research, we emphasize the potential of PACAP as a promising target for migraine treatment, highlighting the significance of exploring PACAP as a member of the antimigraine armamentarium, especially for patients who do not respond to or contraindicated to anti-CGRP therapies. By updating our knowledge of PACAP and its unique contribution to migraine pathophysiology, we can pave the way for reinforcing PACAP and other secretin peptides, including VIP, as a novel treatment option for migraines."

Journal • Review • CNS Disorders • Migraine • Pain • ADCYAP1

Lundbeck presents clinical advances in migraine prevention with positive trial results at international headache congress (Cision) - P2 | N=237 | NCT05133323 | Sponsor: H. Lundbeck A/S | "H. Lundbeck A/S...announces new clinical data supporting the efficacy and tolerability of Lu AG09222 for the preventive treatment of migraine at the International Headache Congress (IHC) 2023 in Seoul, Korea. The presentations also include additional data from a proof-of-mechanism study showing that Lu AG09222 can halt PACAP38-triggered vasodilation and headaches....This trial met the primary endpoint; the difference from placebo in mean change in MMDs from baseline over weeks 1-4 was significant with the Lu AG09222 high dose (-2.0 [90%CI -3.5; -0.6]; one-sided p=0.01). The change from baseline in mean MMDs was -6.2 (standard error [SE] 0.66) with Lu AG09222 high dose and -4.2 (SE 0.67) with placebo. Lu AG09222 was generally well tolerated."

P2 data • CNS Disorders • Migraine • 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. (PubMed, J Headache Pain) - No abstract available

Clinical • Pain

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. (PubMed, J Headache Pain) - P1 | "This proof-of-mechanism study demonstrated that Lu AG09222 inhibited PACAP38-induced cephalic vasodilation and increases in heart rate, and reduced concomitant headache. Lu AG09222 may be a potential therapy against migraine and other PACAP-mediated diseases."

Clinical • Journal • CNS Disorders • Giant Cell Arteritis • Migraine • Pain • ADCYAP1

Lundbeck announces positive phase II Proof of Concept results with Lu AG09222 in migraine prevention (Cision) - P2 | N=237 | HOPE (NCT05133323) | Sponsor: H. Lundbeck A/S | "H. Lundbeck A/S...announced positive results of the HOPE trial, a clinical proof of concept trial of Lu AG09222 as a potential treatment for the prevention of migraine (NCT05133323). The primary analysis concluded that there was a statistically significant difference (p=0.01) between Lu AG09222 and placebo in the mean change from baseline in the number of monthly migraine days over weeks 1 to 4....Lu AG09222 represents a potential new therapeutic option, targeting a pathway in migraine that is distinct from the recently available calcitonin gene-related peptide (CGRP) migraine treatment drug class."

P2 data • CNS Disorders • Migraine • Pain

A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - P2 | N=237 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine

A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - P2 | N=230 | Active, not recruiting | Sponsor: H. Lundbeck A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine

A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: H. Lundbeck A/S | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine

A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: H. Lundbeck A/S | Recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Allergy • Immunology • Inflammation

A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: H. Lundbeck A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine

A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: H. Lundbeck A/S

New P1 trial • CNS Disorders • Migraine

A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: H. Lundbeck A/S; Active, not recruiting ➔ Completed

Clinical • Trial completion • Pain

A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (clinicaltrials.gov) - P2; N=230; Recruiting; Sponsor: H. Lundbeck A/S

Clinical • New P2 trial • CNS Disorders • Migraine

Lundbeck announced the start of a phase II clinical study to assess Lu AG09222 for migraine prevention (Lundbeck Press Release) - "H. Lundbeck A/S (Lundbeck) announced that it has expanded its clinical mid-stage pipeline with the initiation of the HOPE study, a randomized, double-blind, phase II, proof of concept, study to assess efficacy, safety, and tolerability of Lu AG09222 as a treatment for the prevention of migraine....The HOPE study, a phase II double-blind, placebo-controlled study of Lu AG09222, is planned to enroll approximately 230 patients and will assess the efficacy, safety, and tolerability of Lu AG09222 at two doses. Study completion is expected in 2023."

Trial status • CNS Disorders • Migraine • Pain

A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: H. Lundbeck A/S

Clinical • New P1 trial • Allergic Rhinitis • Allergy • Immunology

A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects (clinicaltrials.gov) - P1; N=25; Active, not recruiting; Sponsor: H. Lundbeck A/S; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Pain