Molecular Partners, Allergan to file abicipar BLA in USA in the first half of 2019April 2, 2019
Allergan and Molecular Partners revealed Tuesday the topline safety results from MAPLE, study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process, which showed lower incidence and type of IOI.
In this single arm study, treatment naïve or prior anti-VEGF treated patients received three monthly 2mg abicipar injections followed by 2mg injections every 8 weeks for up to a total of five injections through week 28.
Raj Maturi, Midwest Eye Institute & Associate Professor Ophthalmology, Indiana University School of Medicine, said: “In the Phase 3 trials previously reported, abicipar demonstrated potential that could transform the way physicians manage nAMD with anti-VEGF therapy. Abicipar could be the first fixed 12- week anti-VEGF treatment that improves visual outcomes in a real world setting for a large number of AMD patients.”
“The results of this open-label study enabled us to assess improvements to the manufacturing process for abicipar. The safety profile demonstrated in MAPLE gives us confidence to proceed and scale up manufacturing,” said David Nicholson, Chief Research and Development Officer, Allergan.
He added that the company plans to submit the abicipar BLA and continue to seek manufacturing process improvements.
“Abicipar is our first DARPin candidate on track for BLA submission with the aim to become the first fixed 12-week anti VEGF drug in all patients with nAMD,” said Michael T. Stumpp, COO of Molecular Partners. He added:
Allergan said in the press release it expects to file the abicipar Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2019. Additional data from the MAPLE study will be presented at a scientific conference later in 2019.