Type: Liquid prodrug of nitric oxide, administered via a single intramuscular injection.
Status: Kalytera said July 16 it was granted an exclusive, worldwide license to develop and commercialize R-107 for the treatment of coronavirus and COVID-19 infection by Salzman Group.
The agreement—whose value was not disclosed—is the first step in a larger transaction through which Kalytera plans to acquire Salzman for an undisclosed price. The deal, also of undisclosed value, was announced in May and is expected to close later this year, subject to customary conditions including TSX Venture Exchange and shareholder approvals.
Kalytera said it plans to submit an IND application to the Australian Therapeutic Goods Administration (TGA) and the FDA for a first-in-human Phase I clinical safety and pharmacokinetic trial, designed to assess R-107 in 32 healthy middle-aged volunteers at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia. The study will be initiated during the third quarter, and is expected to be completed during the fourth quarter. Salzman Group agreed to fund all costs for the Phase I study.
Because R-107 is given via a single intramuscular injection, Kalytera says it is easier and less expensive to administer, and offers more sustained and effective delivery, than nitric oxide, which is approved by the FDA for administration to patients via inhalation therapy requiring a special type of delivery device, and administration by trained respiratory therapists.
R-107 has 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. In addition to coronavirus and COVID-19 infection, Salzman Group is also developing R-107 for treatment of chlorine inhalation lung injury, and pulmonary arterial hypertension.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: