— U.S. Phase 2 Trial Met Primary Endpoint with Statistical
Significance
— 48% of Patients in the Risuteganib Arm Gained ≥ 8 Letters of
Vision from Baseline
SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–#DME—Allegro
Ophthalmics, LLC, a privately held biopharmaceutical company focused
on the development of novel anti-integrin therapies for the treatment of
ocular diseases, today announced positive topline results of its U.S.
Phase 2 study of risuteganib (Luminate®) for the treatment of
intermediate nonexudative age-related macular degeneration (dry AMD).
The clinical trial met its primary endpoint with 48 percent of patients
in the risuteganib arm gaining ≥ 8 letters of vision at week 28 compared
to baseline.
The primary endpoint of the Phase 2 study was the proportion of subjects
with a ≥ 8 letters of vision gain with two risuteganib injections versus
one sham treatment. The trial was a prospective, randomized,
double-masked, placebo-controlled, multi-center U.S. study that
evaluated the safety and efficacy of risuteganib in patients with
intermediate dry AMD. At baseline, 40 patients were randomized to
receive either intravitreal 1.0mg risuteganib or sham injection. At week
16, patients in the risuteganib arm received a second dose of 1.0mg
risuteganib, and patients in the sham arm crossed over and received a
single dose of 1.0mg risuteganib. The primary endpoint was the
percentage of the population with ≥ 8 letters ETDRS BCVA gain from
baseline to week 28 in the 1.0mg risuteganib arm versus from baseline to
week 12 in the sham arm. The primary endpoint was prespecified as ≥ 8
letters to account for the variability in visual acuity measurements
among patients with intermediate dry AMD.
The primary endpoint was met with 48 percent of patients in the
risuteganib arm at week 28 and 7 percent of patients in the sham group
at week 12 gaining ≥ 8 letters from baseline (p=0.013). Risuteganib was
found to be safe with no reported drug related serious adverse events
(SAEs). Secondary outcomes, including microperimetry, color vision, and
low luminance visual acuity, are currently being evaluated; results of
which will be released in the upcoming weeks.
“Allegro’s anti-integrin portfolio continues to show great progress,”
said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics,
LLC. “This progress is supported by recent findings released last month
establishing that our ALG-1007 drug candidate for dry eye disease
performed well in an ex-U.S. proof-of-concept clinical trial and now by
these positive topline U.S. Phase 2 results of risuteganib for
intermediate dry AMD. It is very encouraging to see such robust visual
acuity gains in patients with dry AMD, a sight-threatening disease for
which there is currently no available treatment. It is also exciting to
see that these initial clinical findings in dry AMD confirm our
extensive preclinical findings and earlier clinical studies that
suggested risuteganib could restore visual function.”
“I’ve always believed in the potential of integrin inhibition as an
alternative target pathway for the treatment of retinal diseases. This
Phase 2 data is very promising and suggests what we have always hoped to
see: a potential therapy for intermediate dry, nonexudative AMD,” said
Peter K. Kaiser, M.D., Professor of Ophthalmology at the Cleveland
Clinic Lerner College of Medicine and staff surgeon in the Vitreoretinal
Department at the Cole Eye Institute, Cleveland Clinic. “If we could add
a treatment to our armamentarium that can improve vision in this
population of patients that currently is untreatable, this would be
significant. I am hopeful for the future of this drug candidate based on
the consistency of the data that I have seen across different endpoints.”
The full study results, including primary and secondary outcomes, will
be presented by Dr. Kaiser at the American Society of Retina Specialists
(ASRS) Annual Meeting 2019 in Chicago, IL on Saturday, July 27th.
About Allegro Ophthalmics, LLC
Allegro
Ophthalmics, LLC is a privately held biopharmaceutical company
focused on the development of novel anti-integrin therapies for the
treatment of ocular diseases. Allegro’s lead investigational drug
risuteganib (Luminate®) successfully completed two Phase 2 diabetic
macular edema studies and also has successfully completed a U.S. Phase 2
intermediate dry AMD study. Expanding its anti-integrin portfolio,
Allegro has developed ALG-1007, an anti-integrin drug candidate for
topical use in dry eye disease. ALG-1007 has successfully completed an
ex-U.S. proof-of-concept study in humans, and is currently being
evaluated in a larger ex-U.S. Phase 2 study. For more information, visit www.allegroeye.com.
Risuteganib (Luminate®) and ALG-1007 are investigational drugs and
are not approved for commercial sale.
Luminate® is a registered trademark of Allegro Ophthalmics, LLC.
Contacts
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Gray Communications, LLC
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449-9250
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