BioAegis Therapeutics announced that the FDA has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN), for the treatment of decompression sickness (DCS). The company is currently conducting a Phase 2 study of rhu-pGSN for decompression sickness under a contract awarded by the U.S. Navy’s Office of Naval Research to the University of Maryland School of Medicine (UMSOM). This work is the culmination of an extended collaboration with Dr. Stephen Thom, Professor of Emergency Medicine at UMSOM.
BioAegis’ portfolio is built around plasma gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function.
“Fast Track status is granted for products that are addressing areas of strong unmet need with novel, innovative approaches. Dr. Thom’s findings of the role of the NLRP3 inflammasome in this condition in divers is a powerful opportunity for BioAegis to demonstrate the benefits of our platform product which is clearly differentiated from other anti-inflammatory agents. This is just a first step in expansion of BioAegis’ portfolio to the range of challenging diseases driven by inflammasome activation,” states Susan Levinson, PhD., CEO of BioAegis Therapeutics.
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