LOUISVILLE, CO, USA I August 07, 2017 I AntriaBio, Inc. (“AntriaBio”) (OTCQB:ANTB) and ActiveSite Pharmaceuticals (“ActiveSite”) today announced that AntriaBio has exclusively licensed ActiveSite’s oral plasma kallikrein inhibitor portfolio (“Portfolio”) for use in human and animal health, including targeting the treatment of diabetic macular edema and other plasma kallikrein-mediated diseases such as hereditary angioedema.

“The in-licensing of the Portfolio complements our existing clinical and preclinical pipeline, and extends our mission to develop novel therapies for unmet needs in diabetes and other serious diseases,” said Brian Roberts, M.D., Vice President of Clinical Development at AntriaBio. “ActiveSite has generated compelling proof-of-concept for their orally-administered plasma kallikrein inhibitors in clinically-relevant animal models of macular edema, and we are looking forward to leveraging that data to complete IND-enabling toxicology studies and prepare for human clinical trials.”

Under the terms of the agreement, AntriaBio is receiving worldwide rights to the Portfolio and will assume global development, regulatory, manufacturing and commercial responsibilities for product candidates. In turn, ActiveSite will receive an upfront payment and will also be eligible for future payments based upon the achievement of specified development, regulatory and sales milestones, as well as for royalty payments on sales of any commercialized products resulting from the collaboration.

“We are delighted to enter into a strategic relationship with a dynamic and innovative company such as AntriaBio,” noted ActiveSite Pharmaceuticals co-founders, Sukanto Sinha, Ph.D. (CEO) and Tamie Chilcote, Ph.D. (COO). “In particular, we are excited to continue to develop potentially superior therapies for diabetic macular edema and other plasma kallikrein-mediated diseases.”

Diabetic macular edema is the primary cause of vision loss in working-age adults globally. It results from a breakdown of the blood-retinal barrier and an increase in Retinal Vascular Permeability (RVP) caused by a diverse group of conditions, including diabetes. An estimated 750,000 individuals in the U.S. and another six to nine million worldwide have diabetic macular edema. These numbers are expected to grow as the incidence of diabetes increases globally. Current treatment approaches in the U.S. directly target the VEGF pathway and are dominated by anti-VEGF agents such as ranibizumab, bevacizumab and aflibercept, which must be injected into the eye by retinal specialists on a monthly or bimonthly basis. The extent of therapeutic benefit received from these agents directly correlates with adherence to this administration route and regimen, which is a significant burden for both patients and their healthcare providers, leading to high rates of non-adherence to treatment regimens and ultimately, sub-optimal therapeutic outcomes. 

Plasma kallikrein has been shown to be a mediator of increased RVP in animal models of diabetes and hypertension. VEGF-induced RVP and retinal edema in rodents can be significantly reduced by pharmacologic inhibition or genetic knockout of plasma kallikrein. ActiveSite’s lead development candidate is an orally-administered small molecule plasma kallikrein inhibitor, which has been shown to normalize RVP in clinically-relevant animal models of macular edema as effectively as an anti-VEGF agent, thereby supporting its potential as stand-alone therapy for macular edema resulting from diabetes and other causes.

About AntriaBio, Inc. 
AntriaBio is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with diabetes and metabolic diseases. AntriaBio’s lead product candidate is AB101, an injectable once-weekly basal insulin for type 1 and type 2 diabetes that addresses a >$10 billion market where the current standard of care is a once-daily basal insulin injection. For more information, visit: www.antriabio.com.

About ActiveSite Pharmaceuticals
ActiveSite Pharmaceuticals utilizes proprietary lead discovery technology to discover new small molecule drug candidates by targeting proteases, a class of enzymes involved in several human diseases with unmet medical need. ActiveSite’s initial efforts focused on developing novel, innovative treatments for the major vision-threatening complication of diabetes, diabetic macular edema and the genetic disease, hereditary angioedema, by targeting the vascular protease plasma kallikrein. For more information, visit: www.activesitepharma.com.

ActiveSite’s plasma kallikrein inhibitor program was supported by the National Eye Institute of the National Institutes of Health under award number R44EY019629. The content of this announcement is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

SOURCE: AntriaBio