Amorphical is currently conducting a Phase-2 prospective, randomized, placebo-controlled study to assess the Safety, Tolerability, and Efficacy of Amorphous Calcium Carbonate (ACC). In this study, AMOR18—the drug containing the ACC is administered sublingually and by inhalation, concomitantly with Best Available Treatment (BAT), compared to placebo and BAT for treating moderate-to-severe COVID-19 patients.
The Phase-2 study is conducted at five Israeli hospitals. The study was originally designed to include 100 patients in total, with one-on-one randomization (active + BAT vs. placebo + BAT). In December 2021, Amorphical decided to conduct an interim analysis of the study on all 37 patients participating in one of the study institutions. The initial analysis focused on the ratio of admitting the hospitalized patients to the Intensive Care Unit (ICU) and death. Six (6) out of 19 (32%) patients, who were treated with a placebo concomitantly with BAT were transferred to the ICU, two of whom died. None of the hospitalized patients actively treated with AMOR18 were transferred to the ICU or died. Further analysis is underway. More information about the analysis will be added soon.
ACC has already been studied in five other clinical trials and has proven to be safe in treating various diseases. Amorphical’s current multi-site study for treating COVID-19 patients follows the same basic treatment plan as its implementation into the care for late-stage cancer patients, which demonstrates no severe adverse events.
ACC has been found to modulate acidic pH around cells and organs that are associated with numerous diseases and potential stressors on the body. These acidic conditions have been reported to increase the ability of SARS-CoV-2 to attach, penetrate, and replicate inside the host cells, accelerating the spread of the virus. Acidic conditions are also associated with the resulting respiratory inflammation syndromes seen in severe COVID-19 cases.
This simple and straightforward study has the potential to create a new and safe treatment option for COVID-19 and other coronavirus patients. It will hopefully increase recovery rates and prevent deterioration into life-threatening conditions.