Eptinezumab-JJMR

Lundbeck said its next-generation migraine prevention drug cleared the bar in a Phase 2b study, setting the company up for late-stage trials that could start this year. The Danish drugmaker said the IV-delivered medicine, bocunebart (Lu AG09222), was better than placebo at reducing the number of monthly migraine days that patients experienced during a 12-week review. The results were statistically significant. To be included in the trial, dubbed PROCEED , patients had to have failed one to four migraine prevention drugs over the past 10 years. The company didn’t share details such as the scope of the migraine reductions or exactly how the drug and placebo performed relative to each other. It said the drug was “generally well-tolerated” and plans to share more details later. A spokesperson for Lundbeck declined to comment on exactly when the company aims to begin Phase 3 testing of bocunebart. Last March, the company set the second half of 2026 as its goal. Lundbeck hopes bocunebart can open up a new class of migraine prevention drugs. It already markets the migraine medicine Vyepti, which targets CGRP and brought in 4.47 billion DKK ($711 million) last year. The company is competing with multiple other migraine drugs such as Aimovig, Ajovy, Emgality and Nurtec. Bocunebart belongs to a class targeting pituitary adenylate cyclase-activating peptides, or PACAPs, and the company thinks it could address a “broader spectrum of migraine biology” than other treatments for the condition, EVP of R&D Johan Luthman said on an earnings call last November. Abnormal signaling for PACAP can influence pain sensation, neurogenic inflammation and help stoke migraines, Lundbeck has said in presentations. If successful, it could be the first anti-PACAP migraine prevention drug. Eli Lilly dumped a monoclonal antibody targeting that pathway in 2022. Other migraine mechanisms are on the horizon. In December, New York-based Kallyope said its TRPM8 antagonist elismetrep hit the mark in a Phase 2b migraine trial. That drug is entering Phase 3 and could be sent to regulators for review in 2028, CEO Jay Galeota told Endpoints News in December. If bocunebart eventually succeeds, it likely won’t get to market in time to immediately help offset Lundbeck’s looming patent cliffs. About 60% of Lundbeck’s 2025 revenues will run into generic competition between 2026 and 2029, according to a note earlier this month from Jefferies. “The issues at the company are straightforward, not new, and very typical of many other large pharma companies these days, as managements race to build credible pipelines to replace sales from key LOE assets,” Leerink analyst Marc Goodman wrote in a Feb. 4 note to clients. Some of Lundbeck’s earlier-stage medicines could have critical readouts later this year, including experimental medicines for Parkinson’s disease, thyroid eye disease and other indications.

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).