Company To Sponsor Phase 2 Trials in Community-Acquired Pneumonia in Europe

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – November 10, 2014) BioAegis Therapeutics reports that its clinical program was well-­received by two EU regulatory authorities, the MHRA in the United Kingdom and the MPA in Sweden. After completion of required preparatory work the company intends to file a Clinical Trial Application (CTA) and initiate a phase 2a trial in severe community-acquired pneumonia in the EU.


Company to enter Full-Scale cGMP Production for Clinical Trials

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – March 4, 2013) BioAegis Therapeutics announced today it has completed its engineering manufacturing run and is preparing to launch its manufacture of clinical supplies. The campaign to produce recombinant protein in E. coli was successful and generated higher than expected yields. Plasma gelsolin has also been discovered to be an important component of innate immunity that boosts the body’s response to pathogens. Repletion in numerous animal models has been shown to safely prevent morbidity and mortality.


Company to Manufacture Clinical-Grade Supplies for Forthcoming Clinical Trial in Community-Acquired Pneumonia

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – November 26, 2013) BioAegis Therapeutics announced that it has engaged Debra Barngrover Ph.D. to oversee the company’s recombinant manufacturing of plasma gelsolin. Dr. Barngrover is a pharmaceutical process development expert with extensive experience in protein development. She provides regulatory advice and prepares and reviews the Chemistry, Manufacturing and Controls (CMC) sections of regulatory filings. Most recently, she was Vice President, Technology Development, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in more than 40 countries.


Company to Evaluate Orphan Diseases as Secondary Indications

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – July 28, 2013) BioAegis Therapeutics announced that the FDA has transferred Orphan Designations for cystic fibrosis and bronchiectasis to the company. The FDA Office of Orphan Products Development (OOPD) provides support and incentives for sponsors to develop products for rare diseases. For example, The OOPD administers extramural grant programs such as The Orphan Products Clinical Trials Grants Program which provides funding for clinical research. Cystic fibrosis is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States and an additional 70,000 worldwide. Bronchiectasis is a chronic condition where the walls of the bronchi are thickened from inflammation and infection with approximately 110,000 known cases in the US.


BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – July 26, 2013) BioAegis Therapeutics announced today that a patent has been granted in Japan that that covers the diagnostic claims of the therapeutic and diagnostic application. Further Japanese applications for therapeutic claims in inflammation are pending.