Amorphical, a leading Israeli biotechnology company, is proudly announcing the start of patient recruitment for a Phase 2 clinical trial approved by the U.S. Food and Drug Administration (FDA). This trial represents a significant step toward obtaining regulatory approval for AMOR-1, an innovative drug based on groundbreaking nano-amorphous technology.

Hypoparathyroidism, a complex medical condition caused by a deficiency of parathyroid hormone (PTH), which regulates calcium levels in the body, is often the result of thyroid gland removal or genetic and autoimmune diseases. It requires ongoing treatment with high doses of calcium supplements.

The trial, to be conducted at seven leading medical centers in Israel and involving 81 participants, will evaluate the safety and efficacy of AMOR-1, aiming to reduce the need for high calcium supplement doses, maintain normal calcium levels in the blood, and significantly improve patients’ quality of life.

The trial is designed to meet the stringent requirements set by the FDA, with the clear goal of obtaining approval to market AMOR-1 as an official treatment for hypoparathyroidism. Amorphous calcium carbonate, the foundation of Amorphical’s technology, excels in high bioavailability—twice that of traditional crystalline calcium supplements. This bioavailability enables faster and more efficient absorption, reducing the need for high doses and minimizing the side effects associated with traditional calcium supplements.

Furthermore, the unique structure of amorphous calcium ensures stable calcium levels in the blood without the extreme fluctuations that can lead to complications.

The development of AMOR-1, based on Amorphical’s exclusive technology, represents a revolution in the treatment of hypoparathyroidism, offering an innovative and effective alternative for patients who face daily challenges related to their condition.

Amorphical continues to lead the change in the medical world and invites patients and the scientific community to be part of this groundbreaking journey. Together, we will set new standards in the treatment of hypoparathyroidism!