Commercializing a Major Medical Discovery
BioAegis is pursuing a game-changing approach to address medical issues that have previously been seen as out of reach — that is, to prevent the damage caused by excess inflammation but to do this without suppressing the immune system, without putting patients at risk for infection.
“We are simply capitalizing on Evolutionary Wisdom with a natural protein, plasma gelsolin, which has fulfilled this role for vertebrates for millennia.” – Susan L. Levinson, CEO
A Pipeline Intent on Validating Efficacy for Multiple Indications
Initial Focus: Severe Community Acquired Pneumonia (SCAP)
Rhu-plasma gelsolin is a host-directed treatment. It is effective against pneumonia caused by many different types of bacteria, as well as severe viral influenza-caused pneumonia. We recently completed a successful 1b/2a study in hospitalized pneumonia patients. In this Phase 1b/2a blinded, randomized, placebo-controlled, dose-escalation study in sCAP, no serious adverse events or drug-related adverse events were noted in the multiple ascending dose treatment arms.
The treatment was safe and well-tolerated even at the highest doses and supraphysiological levels were maintained throughout the 24-hour dosing interval. Pharmacokinetics supported a once daily treatment regimen in this patient population.
WHY PNEUMONIA IS OUR FIRST TARGET
Facts from the American Thoracic Society
Depletion of Plasma Gelsolin Leads to Dysregulated Inflammation
$50B PIPELINE MARKET OPPORTUNITY
As a master regulator of the immune system, rhu-pGSN is a game-changing anti-inflammatory without immunosuppressive properties. In a wide range of diseases, it balances the inflammatory process to prevent the spread of excess inflammation while simultaneously enhancing antimicrobial defense; thus preventing severe consequences, and greatly improving survival.
We are pursuing multiple secondary indications with unique formulations suited to chronic therapy. Data from animal studies supports efficacious treatment via routes of administration suitable for patient-delivered therapy, including by inhalation and subcutaneous injection.
Applying Cutting Edge Manufacturing
We have partnered with a major contract manufacturer to produce GMP material for clinical and commercial use. Highly productive and efficient processes have been developed for manufacture of this recombinant protein.
Multiple GMP manufacturing runs have been completed and drug product suitable for hospital use has been produced. Long-term drug product stability has been established through 36 months.