Kalytera Announces Data Demonstrating that R-107 Preserves Organ Function in a Murine Study Mimicking COVID-19 Lung Disease

SAN FRANCISCO, May 29, 2020 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTC: KALTF) (the "Company" or "Kalytera") today announced new proof-of-concept data demonstrating that R-107 reduces tissue damage and preserves organ function in a lethal rodent model of sepsis that resembles the circulatory shock seen with COVID-19 associated lung disease.

Kalytera announced on May 19, 2020 that it has entered into a binding Letter of Intent to acquire Salzman Group, Inc., a privately held company located in West Tisbury, MA (“Salzman Group”).  Salzman Group is the owner of R-107, a proprietary drug with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea.

Data from Rodent Study are Strongly Positive
Salzman Group studied the effectiveness of R-107 in a rodent model that is very severe, and is designed to mimic life-threatening COVID-19 infection. It is characterized by a 90% mortality rate within 7 days, with development of tissue injury in the lung, kidney, pancreas, intestine, and liver. This model correlates closely with the human clinical presentation of circulatory shock and multiple organ failure, and thus has served for many decades as a key benchmark in the initial assessment of novel candidate therapeutics for treatment of human sepsis and circulatory shock.

Results from this study were strongly positive, with the active moiety of R-107 demonstrating increased survival from 10% to 90% in septic mice over a week of follow-up. This extraordinary improvement in survival was reflected in the results of blood tests and microscopy showing full tissue protection in all the organs examined, including the liver, lung, and small intestine.

The study was conducted by Professor Salvatore Cuzzocrea, President of the University of Messina, and former President of the European Shock Society.  A sepsis-like syndrome was created in mice by inoculation with bacterial endotoxin, thereby producing a massive release of pro-inflammatory signaling molecules (“cytokines”) such as interleukin-1 beta and tumor necrosis factor alpha, which together are able to trigger the full hemodynamic, hematologic, and immunologic manifestations typical of the lethal human circulatory shock caused by COVID-19 infection.