Commercializing a Major Medical Discovery
Inflammation drives some of the world’s most challenging diseases and is closely linked to aging. While the top biologic anti-inflammatory therapies generate $25–30 billion annually, they come with major drawbacks—they suppress the immune system, leaving patients vulnerable to infection.
BioAegis is pioneering a breakthrough approach to address medical issues that have previously been seen as out of reach — that is, to prevent the damage caused by excess inflammation and to do this without suppressing the immune system… without putting patients at risk for infection.
Replenishing Plasma Gelsolin:
A Platform Approach to Inflammation-Driven Disease
$50B PIPELINE MARKET OPPORTUNITY
As a master/critical regulator of the immune system, rhu-pGSN is a game-changing anti-inflammatory that does not suppress immunity. Across a wide range of diseases, it balances the inflammatory process to prevent the spread of excess inflammation while preserving and strengthening antimicrobial defense. This unique mode of action enables improved survival and reduced morbidity.
We are pursuing multiple indications with unique formulations suited to chronic therapy. Data from animal studies support efficacious treatment via routes of administration suitable for patient-delivered therapy, including by inhalation and subcutaneous injection, enabling ease of use and long-term treatment potential.
Dysregulated inflammation leads to tissue damage and organ failure in many diseases.
Respiratory
Metabolic
Cardiovascular
Neurologic
Autoimmune
Degenerative
A Pipeline Intent on Validating Efficacy for Chronic and Acute Indications
TARGET OUTCOME
INDICATION
PRE CLINICAL
PHASE I
PHASE II
ACUTE
Organ Dysfunction and Mortality
ARDS
Severe Pneumonia
Neuroinflammation
Decompression Sickness
CHRONIC
Inflammation
Inflammatory Arthritis
Undisclosed
Autoimmune
Systemic Lupus (SLE)
Autoinflammatory
Learn more about our active trials with FDA Fast Track designation.
600-Patient Global Study: Infection-Driven Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome (ARDS) has severe consequences for patients. Today there are NO current therapies to treat the condition other than supportive care. In the US alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions. The mortality rate for severe ARDS is ~40%. This mortality as well as damage to organs such as the lung is driven by excess inflammation.
Plasma gelsolin, a normal human protein which regulates the inflammatory process, is critically depleted in ARDS patients and has been shown to address both injurious and infectious inflammation in multiple studies. Treating patients with recombinant human plasma gelsolin (rhu-pGSN) holds much promise for addressing the over exuberant inflammatory response that can lead to ARDS and the subsequent high mortality levels. We are currently conducting a global phase 2 clinical trial for patients with moderate to severe ARDS due to pneumonia or other infections.
We are collaborating with the BARDA DRIVe Solving Sepsis program, to further develop plasma gelsolin for ARDS. BARDA is a division of Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS)..
US Navy Supported Trial: Decompression Sickness, an Inflammatory Condition
BioAegis has advanced recombinant human plasma gelsolin (rhu-pGSN) into a Phase 2 clinical study specifically targeting inflammasome-driven decompression sickness (DCS). The program is being supported by the U.S. Navy’s Office of Naval Research and has received US Fast Track designation from the U.S. FDA, validating the strategic importance of this indication. This study will have major implications across other inflammatory conditions.
DCS, also known as ‘the bends’ in scuba divers is an inflammatory reaction to high-pressure exposure followed by a relatively rapid decrease in pressure which can cause nitrogen gas that had been dissolved in blood and tissues to form gas bubbles in the circulation. Localized deep pain, ranging in severity from mild to excruciating occurs in DCS. The bubbles formed in DCS can interfere with blood flow to tissues and lead to ischemic consequences which can result in severe complications including brain and spinal cord infarction, causing numbness, paralysis, impaired coordination and disorders of higher cerebral function, and may even lead to death. Importantly, these consequences can persist despite hyperbaric chamber treatment.
Rhu-pGSN modulates the inflammatory cascade, including inflammasome activation which is central to DCS pathology. By targeting this underlying immune response rather than just managing symptoms, rhu-pGSN offers a novel therapeutic approach to prevent organ damage triggered by bubble-induced endothelial injury.