Kalytera Provides Data Demonstrating that Prodrug R-107 Provides Sustained Release of Nitric Oxide

SAN FRANCISCO, June 05, 2020 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTC: KALTF) (the "Company" or "Kalytera") today announced new in vivo data demonstrating that R-107 exhibits rapid conversion to its active payload R-100 in rats, followed by sustained release of nitric oxide from R-100.

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.

R-107 is a Nitric Oxide Prodrug
R-107 is a liquid prodrug of nitric oxide that can be administered by injection, unlike nitric oxide gas, which requires a special type of delivery device, and complex administration by trained respiratory therapists. When administered by injection, R-107 is slowly hydrolyzed, releasing its active moiety, R-100, which in turn steadily and slowly releases nitric oxide into the lung tissue.

Put simply, following injection, R-107 is metabolized, and releases R-100, which in turn releases nitric oxide into the tissues of the lung.  R-100 is the pharmaceutically active payload of R-107.

Pharmacokinetic data are Indicative of Rapid Conversion of R-107 to Active Therapeutic Payload
Salzman Group studied the pharmacokinetic characteristics of R-107 when administered at a dose of 10 milligrams per kilogram to rats via an intravenous injection. The purpose of this study was to measure the levels of R-107, and its payload R-100 and the metabolite HMP (generated after release of nitric oxide from R-100), in the plasma of rats following injection. This study is a requirement for an Investigational New Drug (“IND”) application that the Company intends to submit in Q2 2020 to the U.S. Food and Drug Administration (FDA) in support of a first-in-human Phase 1a clinical trial. The Company is planning to carry out a Phase 1a safety and pharmacokinetic study of intramuscular R-107 using a single dose escalation design in healthy middle-aged volunteers at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia.