BioAegis Therapeutics Expands Phase 2 COVID-19 Treatment Clinical Trial in EU for Inflammation Regulator
No drug-related safety signals identified by the independent Data and Safety Monitoring Board.
BioAegis’ Phase 2 clinical trial of recombinant human plasma gelsolin (rhu-pGSN) for the treatment of severe COVID-19 was initiated in August in Spain where COVID-19 cases were spiking. The study assesses rhu-pGSN, and its ability to regulate the overactive inflammatory response often responsible for causing lung damage and death in COVID-19 patients. Rhu-pGSN does not compromise the immune response as compared to other immune suppressive anti-inflammatory agents (e.g. dexamethasone). Low levels of this human plasma protein are associated with severe illness, organ failure and mortality in COVID-19 patients.
Expanding the Clinical Footprint within Spain and into Romania
The company also received approval from the Romania National Agency for Medicines and Medical Devices (NMMD) to extend the trial into Romania. Recruitment for this third site has begun.
The randomized, double-blind, placebo-controlled, proof-of-concept trial of rhu-pGSN is added to standard of care of patients with severe pneumonia due to COVID-19. The study will assess the efficacy (survival without organ failure on Day 14 without mechanical ventilation, vasopressors or dialysis) of three doses of rhu-pGSN administered intrvenously to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5 or 6 on the World Health Organization (WHO) 9-point severity scale. It will also measure the safety and tolerability of treatment along with secondary outcomes.
According to Susan Levinson, PhD, CEO of BioAegis, "The independent Data Safety Monitoring Board has reviewed data from the initial patients and recommends that we continue the study as planned. With enrollment numbers growing, we look forward to further data including clinically meaningful endpoints in these severely ill COVID-19 patients once the study is completed.”
Details of the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04358406
Gelsolin is a Key Component of the Body’s Immune System
Supplementing depleted systemic levels of gelsolin has enormous potential to prevent debilitating and potentially lethal ravages of inflammation, without compromising its essential function to fight infection and promote repair. Its unique qualities are:
BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of infection, inflammatory disease, renal failure, multiple sclerosis and other neurologic diseases. BioAegis has US biologics exclusivity and has recently filed new IP.
This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.
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