BUSINESS WIRE
CINCINNATI--(BUSINESS WIRE)--Aerpio Therapeutics, a clinical‐stage biopharmaceutical company focused
on advancing innovative therapies for the treatment of diabetic eye
disease and inflammatory bowel disease, today announced positive data
from its Phase 1 trial of AKB-9778 for the treatment of diabetic macular
edema (DME). AKB-9778, a first-in-class human protein tyrosine
phosphatase beta (HPTPβ) inhibitor, works to activate Tie2, a receptor
on vascular endothelial cells that promotes vascular stability,
preventing abnormal blood vessel growth and vascular leak. The data show
AKB-9778 was well tolerated through the predicted efficacious dose
range, supporting the clinical advancement of AKB-9778.
“Considering the pivotal importance of Tie2 activation in the retinal
vasculature, we believe AKB-9778 could offer patients with diabetic
macular edema a more effective therapy either alone or in combination
with current therapies. AKB-9778 also offers the important benefit of
being self-administered, which is not possible with currently marketed
treatments,” said Kevin Peters, MD, Chief Scientific Officer and VP of
Research and Development, Aerpio. “We look forward to advancing AKB-9778
in the clinic and expect to start a Phase 1b/2a trial in the second
quarter of 2012.”
The Phase 1 study was designed to evaluate the safety, tolerability and
pharmacokinetics of single ascending doses of AKB-9778 in healthy
volunteers. The trial enrolled 48 healthy volunteers and was conducted
at Medpace, Inc. in Cincinnati, OH. AKB-9778 was well tolerated through
the predicted efficacious dose range with evidence of on-target
pharmacology. Together with preclinical data, these findings support
advancing AKB-9778 into a pilot 1b/2a study to explore the safety and
efficacy of AKB-9778 in patients with diabetic macular edema.
About AKB‐9778
AKB‐9778 works by inhibiting the Human Protein Tyrosine Phosphatase β
(HPTPβ) enzyme, which acts as a negative regulator of the Tie‐2
receptor. By inhibiting this negative regulator, Tie‐2 signaling is
restored, overcoming the effects of the Ang2‐induced vascular
destabilization. Tie‐2 activators have potential utility in a range of
important clinical indications, but Aerpio is currently focusing
development of its lead candidate, AKB‐9778, in diabetic macular edema,
with a Phase 1b/2a trial for that indication planned to start in Q2 2012.
About Diabetic Retinopathy and Diabetic Macular Edema
Diabetic retinopathy, including diabetic macular edema is the leading
cause of visual impairment and blindness in the working age population
and represents a large and growing medical need that is not adequately
addressed by current treatment approaches.
About Aerpio Therapeutics
Aerpio Therapeutics, Inc. is a clinical‐stage biopharmaceutical company
focused on advancing innovative therapies for the treatment of diabetic
eye disease and inflammatory bowel disease. Aerpio is a leader in the
development of small molecule drugs based on Tie‐2 activation and the
stabilization of Hypoxiainducible Factor 1α (HIF‐1α). The company’s lead
program, AKB‐9778, is a first‐in‐class stabilizer of the Tie‐2 pathway
and is in clinical development for diabetic macular edema. AKB‐4924, a
HIF‐1α stabilizer, is in late preclinical development for inflammatory
bowel disease. More information is available at www.aerpio.com.