Lundbeck Halts Subcutaneous Migraine Drug Development, Shifts Focus to IV Formulation

Danish pharmaceutical company Lundbeck has announced a significant change in its migraine drug development program, discontinuing work on a subcutaneous formulation of its anti-PACAP antibody, Lu AG09222, and redirecting efforts towards an intravenous (IV) delivery method. This strategic pivot comes in the wake of a prespecified interim futility analysis that revealed suboptimal efficacy for the subcutaneous administration route.

Phase 2b Trial Restructuring

The decision to halt the subcutaneous cohort stems from a comprehensive review of the phase 2b trial data. Lundbeck had initially designed the study to evaluate multiple administration routes for Lu AG09222, with the flexibility to add an optional intravenous cohort if necessary. The interim analysis, conducted after enrolling 75% of the targeted patients, indicated that the subcutaneous formulation "was not demonstrating the desired treatment effect," according to analysts at Leerink Partners.

As a result of this development, Lundbeck is now pivoting to focus exclusively on the intravenous formulation of Lu AG09222. The company plans to enroll and dose patients in a new intravenous cohort, which will extend the study's completion timeline to the first half of next year. Pending positive results, Lundbeck aims to advance to phase 3 trials in the latter half of 2026.

Industry Context and Challenges

The setback for Lundbeck's subcutaneous formulation adds to a series of challenges faced by anti-PACAP antibody programs in the migraine treatment space. Competitors Amgen and Eli Lilly have previously encountered obstacles with their respective PACAP-targeted therapies. Amgen reported no benefit over placebo for its candidate, while Eli Lilly discontinued development after phase 2 trials.

Despite these industry-wide difficulties, Lundbeck remains optimistic about the potential of Lu AG09222, particularly in its intravenous form. Johan Luthman, Executive Vice President and Head of R&D at Lundbeck, highlighted in a February earnings call that the company's existing intravenous migraine prevention drug is "doing extremely well," suggesting a favorable outlook for the IV administration route.

Market Implications and Future Prospects

The shift to an IV-only development path for Lu AG09222 has raised questions among industry analysts about the drug's market potential. Leerink Partners analysts noted that while Lundbeck may be able to leverage its existing Vyepti clinical infusion infrastructure for Lu AG09222, "the larger opportunity is subq dosing and that opportunity appears to be truncated somewhat."

This development underscores the ongoing challenges in migraine drug development and the pharmaceutical industry's continued efforts to find more effective and convenient treatment options for patients. As Lundbeck progresses with the intravenous formulation of Lu AG09222, the outcome of this revised approach will be closely watched by investors, healthcare providers, and patients alike.