Molecular Partners AG: Abicipar Pegol PALM Study Phase 2 Data in Diabetic Macular Edema (DME); Presented at 2016 AAO Annual Meeting Samstag, 15. Oktober 2016 - 18:30
MEDIA RELEASE
Abicipar Pegol PALM Study Phase 2 Data in Diabetic Macular Edema (DME)
Presented at 2016 AAO Annual Meeting
- Abicipar meets its study end points
- Safety profile of abicipar acceptable
- Data supports progression to phase 3
Zurich-Schlieren, October 15, 2016. Molecular Partners AG (SIX: MOLN) today announced that Tarek S. Hassan, MD, Professor of Ophthalmology at Oakland University William Beaumont School of Medicine and Senior Partner and Director of the Vitreoretinal Fellowship Training Program at Associated Retinal Consultants in Royal Oak, Michigan, presented the data of PALM, A Multicenter, Double Masked Phase 2 Clinical Trial Evaluating Abicipar Pegol (abicipar) for Diabetic Macular Edema (DME) at the American Academy of Ophthalmology Annual Meeting (AAO) 2016 in Chicago.
A total of 151 patients with DME (BCVA ≤75 and ≥24 letters) were enrolled. The efficacy of abicipar was demonstrated in all treatment groups. Abicipar 2 mg (Q8weeks and Q12weeks, following three monthly loading doses) demonstrated functional (BCVA) and anatomical (CRT) effects comparable with monthly ranibizumab, and with fewer injections over a 28 week period. The most common ocular adverse events were vitreous floaters and conjunctival hemorrhage in the abicipar arms. Intraocular inflammation occurred in 7, 5 and 4 patients treated with abicipar 1Q8, 2Q8 and 2Q12 groups, respectively and none with ranibizumab. These adverse events were mostly mild to moderate in severity, and resolved with treatment. These data support progression to phase 3.
Allergan is currently enrolling patients in a phase 3 trial for AMD using an updated formulation of abicipar. Enrollment is progressing well and topline results are expected in 2018.
Christian Zahnd, CEO of Molecular Partners, commented: “We are very pleased to see that abicipar may help certain patients suffering from DME. We look forward to Allergan initiating the phase 3 study in DME.”
The objective of the PALM study was to assess the safety, efficacy, systemic pharmacokinetics, and immunogenicity profile of abicipar in patients with decreased vision due to centrally-involved DME compared to standard of care, ranibizumab. In the double‐masked trial, a total of 151 patients were randomized to abicipar 1mgQ8 (n=43), abicipar 2mgQ8 (n=42), abicipar 2mgQ12 (n=45) or ranibizumab 0.5mgQ4 (n=21) and were followed for 28 weeks. All patients received doses at the start of the trial and at 4 and 8 weeks. Patients who were treated with abicipar received sham injections at 12, 16, 20 and 24 weeks, as applicable. Patients in all arms of the study were well matched at baseline.
The analysis of the primary endpoint showed that after 28 weeks the mean change in BCVA from baseline was 7.2 letters for abicipar 2mgQ12, 7.1 letters for abicipar 2mgQ8, 4.9 letters for abicipar 1mgQ8, and 9.6 letters for ranibizumab. The mean change in BCVA for abicipar includes all patients irrespective of adverse events. The mean change in CRT from baseline, which was the secondary endpoint of the study, was -159.4 mm for abicipar 2mgQ12, -162.0 mm for abicipar 2mgQ8, - 176.4 mm for abicipar 1mgQ8, and -158.8 mm for ranibizumab. The study was not powered to show statistically significant differences between treatment groups.
Additional details on the study are available on the website of the American Academy of Ophthalmology Annual Meeting 2016.
