Amorphical performed study aimed to establish the safety, tolerability, and efficacy of ACC,
named AMOR-18, for treating hospitalized patients with moderate-to severe SARS-CoV-2,
administered as a combination of sublingual powder and inhaled suspensions alongside the
best available treatment (BAT).
After a successful safety study with six patients in Stage 1, the double-blind study was
performed on sixty patients that were randomized to the active and placebo arms with
similar DOS severity. The most significant outcome was the prevention of ICU transfer and
death (0%) in the active arm compared to seven ICU transfers and three deaths in the
placebo arm (23%; Fisher’s P=0.011). The patient improvement rate was significantly higher
in the ACC (93%; 90% CI=82- 98%) compared to the placebo arm (73%; 59-84) in the
intention-to-treat sets. All patients in the active arm were discharged within 10 days from
treatment initiation, and only one related adverse effect (constipation) was reported. There
were no significant differences in responses by age, gender, comorbidities, and vaccination
status.
https://youtu.be/USnVkzHs85M?si=cP-LBXZzJfGfs9XZ
“Sublingual and Inhaled Amorphous Calcium Carbonate for Hospitalized Patients with
SARS-CoV-2: A Phase 1/2 Clinical Study”
Nashet Abu Saleh1 , Yigal Dov Blum2* , Albert El-Roeiy2 , Yafit Stark2 , Kamal Abu Jabal1 , Frederic
Deutch3 1Ziv Medical Center, Tzfat, Israel; 2Amorphical LTD, Nes-Ziona, Israel; 3Biostat, Statistical
Consulting LTD, Nahal Sorek St 15, Modi’in-Maccabim-Re’ut, Israel