Date: 2016-10-15
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Academy of Ophthalmology Annual Meeting (AAO) 2016 in Chicago
Company: Molecular Partners (Switzerland) Allergan (Ireland)
Product: abicipar pegol (anti-VEGF DARPin - AGN-150998/MP0112)
Action
mechanism:
- protein/DARPIN. Abicipar pegol (MP0112) is a DARPin-based, small therapeutic protein, which inhibits all relevant forms of vascular endothelial growth factor A (VEGF-A) with high potency and selectivity. The molecule is under development for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Abicipar was exclusively licensed to Allergan/Actavis from Molecular Partners in May 2011.
Disease: diabetic macular edema
Therapeutic
area: Ophtalmological diseases - Metabolic diseases
Country: USA
Trial
details:
- 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. (NCT02186119)
Latest
news:
- • On October 15, 2016, Molecular Partners 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 at the American Academy of Ophthalmology Annual Meeting (AAO) 2016 in Chicago.
A total of 151 patients with diabetic macular edema (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 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. 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.
Is
general: Yes
