Anti-PACAP antibodies(Cephalon)

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).