Innovation

Amorphical develops and manufactures amorphous calcium carbonate (ACC) in a variety of pharmaceutical forms: tablets, powders, suspensions, and more. As of today, we are marketing several ACC-based calcium supplements.

Our extensive research and observations, as well as our customer reports, give us substantial ground to claim that ACC can be used in the future as a treatment for various medical conditions, from conditions related directly to calcium to diseases such as cancer, hypoparathyroidism and inflammatory diseases.

Amorphical has completed a series of pre-clinical and clinical trials on various medical conditions, including:

1. Metabolic bone disease (BMD): Pre-clinical studies performed by Amorphical prove the superiority of ACC over CCC (crystalline calcium carbonate, of which most calcium supplements available worldwide are made) in terms of solubility, pH (acidity) regulation in biological environments, bioavailability and efficiency in delivering calcium directly into the bones. In addition, Amorphical successfully used ACC to treat bone cysts and fractures in horses–conditions that are virtually incurable with the standard treatments.

2. Improved calcium absorption: Preclinical studies followed by a clinical study in postmenopausal women have shown that fractional absorption (FCA) of calcium from ACC tablets is twice or more the FCA from CCC tablets. Preclinical studies using a model for osteoporosis have shown that ACC helps reduce the rate of bone loss and even increase bone mass.

3. Hypoparathyroidism: In this rare disorder, the body is not producing the hormone that regulates calcium absorption and use. Thus, suffering patients must take daily calcium supplement in doses of up to 10 g. In an initial clinical study conducted by Amorphical, every patient who received ACC instead of their standard calcium supplement daily intake, at calcium doses reduced by half while maintaining normal blood calcium levels. Based on this study, Amorphical received the FDA’s approval to continue to Phase 2 study with an extension to Phase 3.

4. Cancer: Amorphical has performed a series of pre-clinical studies on cells and cancerous tumors treated with ACC versus control and found shifts toward anti-cancer activity and activation of immune response. In addition, we performed 2 initial clinical studies involving terminal (stage 4) cancer patients who had exhausted every available treatment option and had an estimated life expectancy of 3 months or less. The number of such patients who have survived for over a year or two thanks to the experimental treatment or palliative care is gradually increasing.

5. RA and MS: Amorphical’s successful pre-clinical trials on several chronic inflammatory diseases, such as rheumatoid arthritis (RA) and multiple sclerosis (MS), have shown that ACC reduces the activity of Cathepsins (protein degrading enzymes) associated with exacerbation of these conditions. The MS trial also showed improvement in the motor abilities of the animals treated with ACC.

6. Muscular dystrophy: Amorphical has conducted a few pre-clinical studies on muscle cells with Duchenne muscular dystrophy (DMD). ACC helped improve the muscle activity, contraction, morphology and physical ability.

7. Fertility: Pre-clinical studies with ACC have shown improvement in sperm motility, capacitation and count.