Company directs clinical effort of its breakthrough therapy to Acute Respiratory Distress Syndrome, for which there are no currently approved treatments.
NORTH BRUNSWICK, N.J., Jan. 06, 2023 (GLOBE NEWSWIRE) — BioAegis Therapeutics, Inc., a clinical-stage company developing therapies for inflammatory diseases through a portfolio built around plasma gelsolin, a highly conserved and abundant endogenous human immune regulatory protein, reports 2022 highlights.
Completed Major Funding: BioAegis completed a $22 million institutional sale of equity in a non-brokered transaction.
Broadened Clinical Approach: BioAegis broadened its clinical approach to target Acute Respiratory Distress Syndrome (ARDS) including all infectious causes. A Phase 2 clinical trial to supplement depleting systemic levels of gelsolin with BioAegis’ recombinant protein, rhu-pGSN is planned for 2023. It is estimated that in the US alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions with a mortality rate of ~40%.
Expanded Collaborations: BioAegis engaged in multiple collaborations to rapidly develop human proof of concept in an array of infectious and non-infectious inflammatory conditions.
The Company also initiated a collaboration to further explore plasma gelsolin’s ability to interrupt the pervasive inflammatory mechanism of the NLRP3 Inflammasome. The NLRP3 inflammasome is implicated in numerous inflammatory conditions.
In 2022, BioAegis completed multiple deliverables in its DRIVe Solving Sepsis contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services. The contract supports ongoing regulatory and manufacturing activities of gelsolin to treat sepsis. The Company was also selected as an inaugural member of the Sepsis Innovation Collaborative, a multi-stakeholder public/private collaborative with the common mission to address the unmet needs related to infection management and sepsis prevention, detection, and treatment.
Scaled-up Drug Manufacturing: BioAegis completed a manufacturing campaign of drug substance and lyophilized drug product. The Company also initiated a new manufacturing campaign with Fujifilm Diosynth to further scale up production to secure additional supplies in support of its ARDS clinical program, its expansion into secondary indications, and to begin preparations for commercialization.
Expanded Patent Protection: Additional patents were issued to BioAegis, expanding its portfolio to 44 patents for coverage in inflammatory disease, infection, renal failure and neurologic disease.
Appointed New Board Members and Clinical Advisors: BioAegis appointed Dr. Kerry Maguire and Kris Vinckier, to the Corporate Board to add to its financial, strategic and global health expertise. The Company also appointed three new clinical advisors who are internationally recognized key opinion leaders in ARDS to guide its clinical efforts and facilitate its progress toward commercialization.
Susan Levinson, Ph.D., Chief Executive Officer of BioAegis stated, “I am proud of our significant progress this past year. Our plan is to accelerate the development of gelsolin to provide an essential tool to address diseases which currently have no effective treatment.”
BioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection.
BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens, but normal levels are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form, rhu-pGSN, helps immune cells fight infection and controls inflammation so it does not spread and cause damage. Rhu-pGSN is a non-antibiotic, host-directed, non-immunosuppressive treatment for inflammation due to both infectious and non-infectious causes.
BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, and neurologic disease. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need.
This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.