Adamis Pharmaceuticals Announces IND Submission to FDA for Tempol for the Treatment of COVID-19
SAN DIEGO, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol
for the treatment of Coronavirus (COVID-19). The submission of the IND to FDA followed a Pre-IND meeting with FDA in which FDA gave specific recommendations on Chemistry, Manufacturing and Controls
(CMC) and Clinical aspects to be included in the IND. The Company plans to seek government and/or non-government funding to study the treatment and prevention of COVID-19 with Tempol.
Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients. Numerous published articles describing animal models of ARDS show Tempol to cause a decrease in lung inflammation and preserve lung pathology associated with acute and chronic lung injury. To this end, Tempol has been shown to decrease the genes (HIF-la and HIF-2a) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19.
Dr. Dennis J. Carlo, President and CEO of Adamis commented: “With over 23 million COVID-19 infections in the US and over 394,000 deaths in the US (according to the CDC), additional treatments are urgently warranted. We believe that Tempol could play a pivotal role not only in the treatment of COVID-19, but actually in preventing hospitalization. With new mutations occurring in the virus, it is apparent there is an ongoing need for new therapies. The South African and other variants could very well evade the protection of antibody treatments and also bring up concerns about the efficacy of the current COVID-19 vaccines. Mutations can possibly render these vaccines less potent and could require them to be updated as with influenza vaccines.”