Molecular Partners AG: Abicipar phase 3 data presented at AAO Conference in Chicago: Potential to be the first fixed 12-week anti-VEGF therapeutic Montag, 29. Oktober 2018 - 07:00
MEDIA RELEASE
Abicipar phase 3 data presented at AAO Conference in Chicago: Potential to be the first fixed 12-week anti-VEGF therapeutic
Zurich-Schlieren, October 29, 2018. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin® therapeutics* to treat serious diseases, today announced that the phase 3 safety and efficacy data of abicipar in patients with neovascular Age-related Macular Degeneration (nAMD) were presented at the American Academy of Ophthalmology (AAO) conference in Chicago.
In two global phase 3 studies, called SEQUOIA and CEDAR, a total of more than 1,800 patients with nAMD were treated with a fixed treatment regimen of either 2 mg abicipar every 12 weeks (2q12) or every 8 weeks (2q8) following three loading doses, or the comparator, monthly ranibizumab (Lucentis®).
The data show that both abicipar regimens met the pre-specified criteria for non-inferiority to monthly ranibizumab for the primary endpoint (defined as stable vision at week 52) in both SEQUOIA and CEDAR. Additionally, the initial vision gains for abicipar fixed 2q12 and fixed 2q8 were maintained throughout week 52.
The anatomical data (OCT) on abicipar-treated patients showed reductions of central retinal thickness (CRT) in all arms in both studies in the same range as for ranibizumab. Overall, the efficacy endpoints at week 52 showed comparable efficacy with 6-8 injections of abicipar vs. 13 injections of ranibizumab.
The overall incidence of treatment emergent adverse events was comparable among all three treatment groups. Abicipar-treated patients had a higher risk of developing intraocular inflammation (IOI) compared to ranibizumab-treated patients. The majority of IOI were mild to moderate and were treated with topical corticosteroids.
“The data presented at AAO represent another significant milestone for Molecular Partners, as our first DARPin® candidate has generated positive Phase 3 data,” commented Dr. Patrick Amstutz, Chief Executive Officer of Molecular Partners.
“We are very impressed by the vision and anatomical data presented,” added Dr. Michael Stumpp, Chief Operating Officer of the company. “These data underline that abicipar has the potential to become the first fixed 12-week anti-VEGF therapeutic.”
Allergan plans to file abicipar with the FDA in H1 2019 pending a pre-BLA (biologics license application) meeting with the FDA. Additionally, Allergan expects to share results from the MAPLE trial, using a further optimized formulation of abicipar, in H1 2019.
Financial Calendar
November 1, 2018 | Q3 2018 Management Statement |
December 6, 2018 | R&D Day in New York |
February 7, 2019 | Publication of Full-year Results 2018 (unaudited) |
March 15, 2019 | Expected Publication of Annual Report 2018 |
April 16, 2019 | Annual General Meeting |
http://investors.molecularpartners.com/financial-calendar-and-events/
