|[July 01, 2014]
Stage 3 Phase 2 study of DARPin abicipar pegol (previously MP0112) supports progressing to phase III development program
ZÜRICH-SCHLIEREN, Switzerland --(Business Wire)--
Molecular Partners AG announced today results from the
Allergan-sponsored, double-masked stage 3 phase 2 study of the DARPin
abicipar pegol, for wet age-related macular degeneration (AMD (News - Alert)). The
results demonstrate that abicipar pegol provides equal or potentially
higher vision gains compared to ranibizumab (Lucentis®) with fewer
injections. Further, Allergan announced that full phase III development
is anticipated to start in Q2 of 2015.
Abicipar pegol (previously AGN (News - Alert)-150998 or MP0112) is a long-acting potent
antagonist of vascular endothelial growth factor (VEGF), which is based
on the DARPin® technology. Abicipar pegol was licensed to Allergan from
Molecular Partners in May 2011.
Christian Zahnd, CEO of Molecular Partners commented: "We are very
pleased to see our previous findings confirmed that this DARPin has the
potential to bring substantial patient value by potentially providing
equal or better efficacy with a more patient-friendly dosing regimen as
compared to standard of care. This is a great showcase for our DARPin
platform which has potential to deliver differentiated programs not only
in ophthalmology, but also in other indications such as oncology. Also,
we are very happy to see Allergan's high commitment to advance the
DARPin through an impressive clinical development program."
Michael Stumpp, CSO of Molecular Partners further added: "We are very
happy to have supported Allergan in the development of Abicipar,
especially on the manufacturing process. For patients with wet AMD,
maximizing vision gain and minimizing the frequency of treatments remain
the most important needs. We look forward to sharing these important
data with the scientific community at one of the retina meetings later
Further details of the REACH phase 2 stdy (stage 3):
In stage 3 of the phase 2 study, the safety, efficacy and duration of
action of abicipar pegol was investigated compared to the standard of
care for wet AMD, ranibizumab. In the double-masked trial, a total of 64
patients were randomized to abicipar pegol 1mg (n=25), abicipar pegol
2mg (n=23) or ranibizumab 0.5mg (n=16) and were followed for 20 weeks.
All patients received doses at the start of the trial and at 4 and 8
weeks. Patients in the ranibizumab arm of the study received additional
doses at 12 and 16 weeks. Patients who were treated with either dose of
abicipar pegol received sham injections at 12 and 16 weeks. Patients in
all arms of the study were well matched for demographics and baseline
The analysis of the topline data showed that after 16 weeks, mean visual
acuity improvement from baseline was 8.2 letters for abicipar pegol 2mg,
6.3 letters for abicipar pegol 1mg, and 5.3 letters for ranibizumab.
After 20 weeks (12 weeks after the last abicipar injection and 4 weeks
after the last ranibizumab injection), mean visual acuity improvement
from baseline was 9.0 letters for abicipar pegol 2mg, 7.1 letters for
abicipar pegol 1mg, and 4.7 letters for ranibizumab. In addition,
Optical Coherence Tomography (OCT) data was supportive of the visual
acuity data. Although the study was not powered to show statistically
significant differences between treatment groups, these data suggest
that the DARPin at the 2 mg dose is at least as effective as monthly
ranibizumab, with a longer duration of action of the DARPin.
There were no serious adverse events reported in any study group. Two
patients in the abicipar pegol 2mg arm and three patients in the
abicipar pegol 1mg group experienced ocular inflammation adverse events.
Allergan and Molecular Partners have been working to enhance the
manufacturing process for abicipar pegol and Allergan announced that it
plans to initiate Phase 3 studies in the second quarter of 2015, when
material from the new manufacturing process is available.
Notes to editors:
About Molecular Partners AG
Molecular Partners is a privately-owned biotech company focusing on the
research, development and commercialization of a novel class of
biological drugs known as DARPins. The company is committed to create
medicines for diseases with unmet medical need and to dramatically
improve existing therapies. DARPins combine the high specificity,
selectivity and safety of monoclonal antibodies with many advantages of
small molecules, including high stability and low-cost production.
Molecular Partners has established a strong DARPin pipeline which is
well differentiated from standard therapeutic approaches. Next to
ophthalmology, Molecular Partners is focusing on DARPin drugs in
oncology, immunology and other disease areas. The internal pipeline is
expanded by partnered programs with leading pharmaceutical companies.
Molecular Partners has established alliances with Allergan, Hoffmann-La
Roche, Janssen and other pharmaceutical companies. The company is backed
by a strong syndicate of investors and holds a strong patent estate
covering all DARPin applications. For more information regarding to
Molecular Partners, go to: www.molecularpartners.com.
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