Ongoing Clinical Researches

Amorphous calcium carbonate (ACC) is a special unstable form of calcium carbonate found
in nature. It protects aquatic life and covers a significant portion of the Earth’s crust. 

It can help with calcium deficiencies and regulate pH in biological systems when stabilized.
ACC treatment is expected to help patients with Inflammatory Bowel Diseases (IBD) in
several ways:

1. It can help balance acidity in the body, which is linked to immune problems seen in
    IBD.

2. Time-release capsules of ACC can deliver it directly to the affected parts of the
     intestines, reducing inflammation and symptoms.

3. Previous studies have shown that ACC has anti-inflammatory and immune-
    modulating effects, which could benefit IBD patients by regulating their immune
    response.

Amorphous calcium carbonate (ACC) nanoparticles, smaller than 100 nm, can penetrate
membranes in the body, reaching the blood and interstitial fluids. This unique capability
contributes to ACC’s superior biomedical effects compared to other calcium supplements.
Once inside the body, ACC nanoparticles dissolve under certain conditions, releasing calcium
and carbonate ions. This dissolution and ACC’s nanometric structure lead to various
therapeutic effects, including cancer treatment, inflammation suppression, pain reduction,
muscle improvement, and bone health enhancement. These effects are linked to
neutralizing acidic environments in the body. Studies have shown ACC’s effectiveness when
administered through different routes, including injection, sublingual, and inhalation,
indicating its systemic nature.

Amorphical is embarking on an exciting journey with a prospective, randomized, parallel,
placebo-controlled study to investigate the potential of PH Gastrilex in treating adults with
moderate to severe Crohn’s Disease (CD). Participants will either receive ACC “PH Gastrilex”
or a placebo alongside their current treatment for 24 weeks.
In the first 12 weeks, one group will receive PH Gastrilex while the other will receive a
placebo. Then, in the next 12 weeks, those initially receiving the placebo will switch to active
treatment, while the first group continues with PH Gastrilex.

Throughout the trial, participants will undergo various assessments, including physical
exams, vital sign checks, and laboratory tests. Urine and stool samples will be collected, and
colonoscopies will be performed at the beginning and end of the trial. Adverse events and
medication use will be closely monitored, with regular check-ins and reminders to keep
participants engaged.

This study promises to shed light on the safety, tolerability, and efficacy of PH Gastrilex in
managing Crohn’s Disease, offering hope for improved treatment outcomes for those
affected.