PITTSBURGH–(BUSINESS WIRE)–CytoAgents, a clinical-stage biotechnology company, announced today that enrollment has started for its Phase 1 clinical trial with lead drug candidate, GP1681, for treatment of COVID-19 “cytokine storm,” clinically known as hypercytokinemia.

A randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GP1681 in healthy adults, the Phase 1 Trial, is being conducted in partnership with contract research organization, Novotech, and clinical trial unit, CMAX Clinical Research, in Australia. The company anticipates trial completion with results early in 2021, which will support the initiation of a Phase 2 Trial immediately thereafter.

“We are pleased to announce the start of a new clinical trial designed to evaluate the use of GP1681 as a potential new medicine to treat the severe immune response to COVID-19,” said Teresa Whalen, RPh, CEO of CytoAgents. “The world has an urgent need for new treatments to address the present and future viral epidemics, including those marked by hypercytokinemia and its associated morbidity and link to mortality. We are building a powerful treatment platform for respiratory illness that ultimately creates a powerful, lasting solution for cytokine storm and for any respiratory epidemic.”

Scientific consensus is building that severe illness caused by influenza, COVID-19 and other infectious diseases is triggered by hypercytokinemia, an excessive immune response that attacks the body. GP1681 is a small molecule inhibitor of cytokine release in activated human immune cells that addresses an unmet need for therapeutic treatment. It has been shown to safely modulate the natural immune response by tamping down various cytokines and addresses the underlying cause of life-threatening symptoms associated with “cytokine storm,” which can cause more harm than the virus itself. GP1681 differentiates itself from other immunotherapy solutions as it will be an affordable, oral therapeutic that targets the optimal range of cytokines as an important component of a multi-faceted treatment plan.

“CMAX is excited to be part of this innovative trial of a potential new medicine to treat the severe immune reaction that can result from COVID-19 and other infectious viruses,” said Dr. Angel Molga, principal investigator at CMAX Clinical Research. “We welcome the study and are excited to already be enrolling participants.”

CytoAgents has previously received a Phase II SBIR grant of $1.6 million in non-dilutive funding from the National Institute of Allergy and Infectious Diseases of the NIH, under Award Number 1R44AI152726-01, to advance the research of GP1681, as well as recent funding from the Richard King Mellon Foundation’s Pandemic Solutions Package to jump-start COVID-19 response strategies.

About CytoAgents
CytoAgents is a privately held biotechnology company focused on the development of innovative pharmaceutical products for the treatment of COVID-19, influenza, viral infectious diseases, and conditions that cause acute respiratory distress. Using a novel, host-directed approach, our lead compound, GP1681, targets the underlying cause of life-threatening respiratory distress, cytokine release syndrome, by modulating the body’s natural immune response to sickness or disease. We are committed to developing first-in-class, best-in-class products that meet a major medical need now and into the future.

About Novotech
Established in 1996 and headquartered in Sydney, Novotech is focused on the Asia Pacific region, running clinical trials in all key regional markets including China, India, Australia, Taiwan and South Korea, Hong Kong and New Zealand. Novotech also has worldwide reach through the company’s network of strategic partners. Novotech, described by Frost & Sullivan as the best in its industry class for biotech-focused CROs, brings its global reputation for high quality service and regional expertise to the high-growth Asia Pacific area.

About CMAX
CMAX is one of Australia’s largest and most experienced Phase 1-11 clinical trial units. Operating for more than two decades, CMAX conducts successful, world-leading research for local and international clients, specializing in a range of early-phase trials and first-in-human studies.