MORRISTOWN, N.J., Aug. 07, 2019 (GLOBE NEWSWIRE) — BioAegis Therapeutics, Inc. announced the major findings from its Phase 1b/2a study of Recombinant Human Plasma Gelsolin for patients requiring hospitalization because of Community-Acquired Pneumonia.
This blinded placebo-controlled trial was a dose-escalation study with four cohorts of 8 patients randomized 3:1 to recombinant gelsolin versus placebo. The highest-dose cohort receive 3 consecutive daily doses of 24 milligrams per kilogram of body weight. As anticipated, no serious or drug-related adverse events were reported in what were the highest doses ever administered to patients. Furthermore, analysis of the pharmacokinetics demonstrated that the product half-life exceeded 12 to 16 hours which supports once-daily dosing.

See the full release here: 2019 08 06 Phase 1b 2a Results


MORRISTOWN, NJ, (BIOAEGIS THERAPEUTICS) April 30, 2019 BioAegis Therapeutics Inc., a privately held biotechnology company commercializing recombinant human plasma gelsolin (pGSN) announced today that the United States Patent Office has issued a patent for the Use of Plasma Gelsolin to Diagnose and Treat Renal Failure.

Read the full press release here: Renal Patent 2019


MORRISTOWN, NJ (March 18, 2019). BioAegis Therapeutics Inc. announced that it has completed patient enrollment in its Phase 1b/2a study of recombinant plasma gelsolin (rhu-pGSN) as adjunctive therapy for patients requiring hospitalization because of Community-Acquired Pneumonia (CAP).
A Novel Approach to Create a New Treatment Paradigm
Severe CAP is the lead indication of this clinical-stage company that addresses infectious, inflammatory and degenerative diseases with supplementation of an endogenous protein that is depressed in these disorders.
Patients were treated with recombinant human plasma gelsolin (rhu-pGSN) or a matching placebo in this blinded randomized clinical trial.

Read the full press release here: 2019 03 18 Completes Enrollment Phase 1b_2a


MORRISTOWN, NJ, (BIOAEGIS THERAPEUTICS) March 13, 2019 BioAegis Therapeutics Inc., a privately held biotechnology company commercializing plasma gelsolin (pGSN), an endogenous human protein that harnesses the innate immune system to modulate the inflammatory response as well as boost the capacity of immune cells to fight infection announced today that the European Patent Office has issued a patent for the Use of Plasma Gelsolin to Treat Infections.  This grant adds to BioAegis’ infection portfolio already covered by patents in the US, China and other territories.

Read the full press release here: European Infection Patent


MORRISTOWN, N.J., Feb. 07, 2019 (GLOBE NEWSWIRE) — BioAegis Therapeutics Inc. announced that patient enrollment is underway in a Phase 1b/2a study of recombinant plasma gelsolin (rhu-pGSN) in Community-Acquired Pneumonia (CAP) in the Republic of Georgia. The clinical-stage company is focused on a novel approach to address infectious, inflammatory and degenerative diseases through a portfolio built around the supplementation of plasma gelsolin levels. The Data Safety Monitoring Board (DSMB) met on 25 Jan 2019 to review the safety data for the 6 mg/kg multiple dose level (cohort 2). Review of the safety data did not reveal any safety concerns and accordingly the DSMB recommended to start enrollment into the 12 mg/kg multiple ascending dose level (cohort 3).

Read the full press release here: BioAegis Expands Phase 1b_2a Community-Acquired Pneumonia Study to the Republic of Georgia