Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases.

Global Phase 2b clinical trial underway evaluating rhu-pGSN for the treatment of moderate to severe ARDS.

BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN) for the treatment of acute respiratory distress syndrome (ARDS). The company’s portfolio is built around gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function.

What Fast Track Designation Means to BioAegis and Patients
The FDA Fast Track program is designed to facilitate the development of new therapies for serious conditions with high unmet medical needs. Fast Track status enables more frequent interactions with the FDA, including rolling review of the marketing application, and eligibility for priority review, which can significantly accelerate time to market. For BioAegis, this designation highlights the therapeutic promise of rhu-pGSN and provides a clear regulatory pathway to expedite its development as a treatment for ARDS.

ARDS is a life-threatening condition marked by severe pulmonary inflammation and fluid accumulation in the lungs. Even with aggressive medical management, 40% of ARDS patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life.

In the U.S. alone, ARDS affects over 500,000 patients per year, or roughly 10% of all ICU admissions. With no effective pharmacological therapies currently available for ARDS and its high mortality rate driven by excessive inflammation, there is an urgent need for innovative treatments in this field. BioAegis is currently enrolling patients in a 600-patient global Phase 2b trial to evaluate the efficacy and safety of rhu-pGSN in moderate to severe ARDS (NCT05947955).

As part of the Fast Track designation, rhu-pGSN may also be made available to patients through the FDA’s Expanded Access or Compassionate Use program, offering a potential treatment option for those who are not eligible for clinical trials and have no alternative therapies.

“Receiving FDA Fast Track designation is a critical milestone for BioAegis and further validates the potential of gelsolin to address the urgent and unmet needs of ARDS patients. Despite the high mortality of ARDS and its major strain on our healthcare system, no approved treatments currently exist. Fast Track status brings us closer to delivering an effective therapy for this devastating condition,” states Susan Levinson, PhD., CEO of BioAegis Therapeutics.

Gelsolin: A Multitasking Protein for Complex Inflammatory Conditions
Gelsolin holds immense promise as a therapeutic intervention for serious acute and chronic conditions due to its multifaceted mechanism of action.  In critical illness, gelsolin levels collapse, causing adverse outcomes. Supplementing gelsolin addresses this deficit directly—restoring immune balance while preserving host defense—and has been shown in both animals and humans to:

• Modulate the activation of the NLRP3 inflammasome.
• Enhance uptake and killing of microbial pathogens by innate immune cells.
• Bind to and remove harmful inflammatory mediators and toxic actin released from damaged cells.
• Regulate macrophage phenotype to modulate inflammation.

Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated many inflammatory diseases without suppressing immune function.