Aerpio Therapeutics Reports Peer-Reviewed Publication of Positive Clinical Results from the Phase 2a Study of Lead Candidate, AKB-9778, in Diabetic Macular Edema (DME): The TIME-2 Trial

CINCINNATI–(BUSINESS WIRE)–Aerpio Therapeutics, Inc., a biopharmaceutical company focused on
advancing first-in-class treatments for the eye, today announced that
clinical data from the company’s Phase 2a study of its lead candidate,
AKB-9778, for the treatment of patients with DME, have been published in
an article titled “Enhanced Benefit in Diabetic Macular Edema from
AKB-9778 Tie2 Activation Combined with Vascular Endothelial Growth
Factor Suppression,” which is currently available
online in the peer-reviewed journal Ophthalmology. As
previously announced in an oral presentation at the most recent American
Academy of Ophthalmology Annual Meeting (November, 2015), the
combination of AKB-9778 (dosed at 15 mg BID subcutaneously) and
Lucentis® (ranibizumab injection dosed at 0.3 mg intravitreally)
provided a clinically significant benefit in reduction of macular edema,
as measured by central subfield thickness (CST), compared to Lucentis®
alone at month 2 (p=0.02) and at end of treatment at month 3 (p=0.008).
In association with the improvement in CST, the combination therapy
showed a trend towards improved visual acuity (proportion of patients
achieving improvement of at least 3 lines in visual acuity) when
compared to Lucentis® alone.
Further, data from the TIME-2 study demonstrated the ability of
systemically administered AKB-9778 monotherapy to improve underlying
diabetic retinopathy by 2 or more steps in both study and fellow eyes
without the need for intraocular injections . In regard to the safety
profile, there were no clinically significant differences in the
percentage of patients that experienced ocular or non-ocular adverse
events across the three study arms.
“The TIME-2 study has provided broad mechanistic support for the
potential use of AKB-9778 in promoting the stabilization of vascular
beds,” commented Dr. Steve Pakola, Aerpio’s Chief Medical Officer. Dr.
Pakola continued, “Based on these promising results, we are continuing
our preparations to advance AKB-9778 into late stage clinical studies in
DR and DME. As previously reported, we anticipate targeting additional
ophthalmic indications as well, including wet age-related macular
degeneration (wAMD).”
About the TIME-2 Study
TIME-2 was a Phase 2a, randomized, double-masked, placebo-controlled,
proof-of-concept study in DR patients with DME. The TIME-2 study
evaluated 144 patients randomized equally (1:1:1) to AKB-9778 as
monotherapy or in combination with Lucentis® compared with Lucentis®
alone for a treatment period of 3 months, followed by a 2-month
observation period. The study’s primary endpoint measure was mean change
from baseline in CST at 3 months. Secondary endpoint measures included
visual acuity and safety outcomes.
About AKB-9778
AKB-9778 is a first-in-class small molecule that inhibits the enzyme,
vascular endothelial protein tyrosine phosphatase (VE-PTP), which acts
as a negative regulator of the Tie2 receptor. By inhibiting this
negative regulator, Tie2 signaling is restored, overcoming the effects
of vascular destabilization. Aerpio is initially focusing development of
AKB-9778 in DR and DME, with potential for development in other vascular
retinal disorders, including wAMD.
About Aerpio Therapeutics
Aerpio Therapeutics, Inc. is a clinical-stage biopharmaceutical company
focused on the development of novel therapeutics for the treatment of
vascular disorders with an emphasis on diseases of the eye. Aerpio is a
leader in the development of therapeutics based on Tie2 activation. The
Company’s lead program, AKB‐9778, is a first‐in‐class small molecule
stabilizer of the Tie2 pathway and is in clinical development for DR and
DME. More information is available at www.aerpio.com.
Lucentis® is a registered trademark of Genentech, Inc.