Omni Bio Pharmaceutical Announces Presentation Of Phase 1/2 Clinical Data For AAT At American Heart Association Scientific Sessions

FORT COLLINS, CO--(Marketwired - November 19, 2014) - Omni Bio Pharmaceutical, Inc. (PINKSHEETS: OMBP) (“Omni Bio”), an emerging biopharmaceutical company focused on revolutionizing the treatment of immune-mediated inflammatory diseases, announced today the presentation of Phase 1/2 clinical data for plasma-derived alpha-1 antitrypsin (“p-AAT”), demonstrating its ability to inhibit the inflammatory response in patients with acute ST-elevation myocardial infarction (“STEMI”), the most severe type of heart attack. The data were presented yesterday in a poster at the American Heart Association Scientific Sessions 2014, in Chicago. Importantly, these latest clinical findings further highlight the potential value of Omni Bio’s first-in-class recombinant AAT candidate, AAT-Fc.

STEMI patients are at particularly high risk for developing heart failure due to tissue damage caused by the intense inflammatory response that occurs following acute myocardial infarction. It is well-known that the degree of inflammation at the time of a heart attack is predictive of adverse outcomes including unfavorable cardiac remodeling, heart failure and cardiac death. In the current study, principal investigator Antonio Abbate, M.D., Ph.D., and colleagues at The Virginia Commonwealth University concluded that a single administration of p-AAT significantly inhibited the acute inflammatory response following STEMI, and was associated with a decreased incidence of heart failure over a 12-week follow up period.

Charles Dinarello, M.D., Chief Scientific Officer of Omni Bio and co-author of the poster presentation, stated, “There is a need to develop new treatments to prevent heart failure after acute myocardial infarction. More than 20% of STEMI survivors are diagnosed with heart failure within 30 days of their original injury, leading in many cases to death. Our approach is to control the inflammatory response such that it promotes healing within the heart tissue without causing further damage that leads to heart failure. We are very pleased with the clinical results, which demonstrate p-AAT may prove to be a safe and potentially effective intervention for this high-need indication.”

Bruce Schneider, Ph.D., Chief Executive Officer of Omni Bio, added, “Clinical studies of p-AAT with outcomes such as these continue to demonstrate the anti-inflammatory and tissue-protective attributes of AAT, and in doing so accelerate and de-risk the development pathway for our recombinant AAT-Fc program. Presentation of this peer-reviewed poster further validates the potential for our AAT-Fc product candidate, which has demonstrated superior potency and longer half-life compared to plasma-derived products in a variety of animal models, as well as the potential for improved safety, easy-to-administer subcutaneous dosing, and significantly enhanced manufacturing scalability.”

Omni Bio controls intellectual property related to the use of both p-AAT and Fc-AAT for the treatment of a wide variety of immune-related inflammatory diseases including, but not limited to, post myocardial infarction remodeling, diabetes and graft versus host disease.

About the Phase 1/2 Study(1)
Ten adult patients were treated with a 60 mg/kg dose of p-AAT within 12 hours of hospital admission for STEMI. The infusion of p-AAT was tolerated by all patients without any in-hospital adverse events, and a significant 36% increase in plasma AAT was confirmed 72 hours after dosing (p=0.005). Levels of high-sensitivity C-reactive protein (“CRP”), which typically increases in response to inflammation, were significantly lower between admission and the 72-hour time point for patients treated with p-AAT compared to historical placebo controls (p=0.007). No patients in the treatment arm had recurrent MI or new onset heart failure during the 12-week follow up period, compared to 15% and 30% of patients, respectively, in the historical control group.

About Omni Bio Pharmaceutical, Inc.
Omni Bio Pharmaceutical, Inc. (“Omni Bio”) is an emerging biopharmaceutical company focused on revolutionizing the treatment of immune-mediated inflammatory disease. The Company’s technology platform, AAT-Fc, is a recombinant version of plasma-derived alpha-1 antitrypsin (p-AAT), a naturally occurring human protein that is currently commercialized as an intravenous supplementation therapy for AAT-deficient individuals. Omni Bio seeks to capitalize on emerging scientific evidence of AAT’s fundamental role in mediating multiple anti-inflammatory and tissue protective pathways by developing first-in-class therapeutics to address a broad array of new clinical opportunities.

Omni Bio’s recombinant AAT-Fc can offer several potential advantages over current p-AAT products, including superior potency, longer half-life, improved safety and easy-to-administer subcutaneous dosing, as well as significantly enhanced manufacturing scalability. Omni Bio intends to exploit AAT-Fc’s enhanced product potential to address multiple, high-value immune-mediated inflammatory disease indications, such as Type 1 diabetes, graft versus host disease and chronic gout. The Company holds broad intellectual property covering both recombinant and plasma-derived AAT for these and other indications.

For more information, please visit http://www.omnibiopharma.com.

(1)Alpha-1 antitrypsin (AAT) to quench the acute inflammatory response in ST-segment elevation acute myocardial infarction. ClinicalTrials.gov identifier: NCT01936896

Forward-Looking Statements
This press release contains forward-looking statements that reflect the Company’s current expectations as of the date of this press release, and involve certain risks and uncertainties that could cause actual results to differ materially from those anticipated in these forward-looking statements. Factors that could cause future results to materially differ from forward-looking statements include the risks described in Omni Bio Pharmaceutical, Inc.'s Form 10-K for the fiscal year ended March 31, 2014 and other reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements. The Company’s further development is highly dependent on raising capital to support its activities, future medical and research developments and market acceptance, and other risks that are outside of the Company’s control.