Amorphical Announces Full Patient Enrollment in Phase 2 FDA Clinical Trial of AMOR-1 for the Treatment of Hypoparathyroidism

Novel Nano-Amorphous Calcium Carbonate Technology Platform Aims to Maintain Optimal Serum Calcium Levels Using Half the Elemental Calcium Dose of Conventional Treatments

NES ZIONA, Israel, July 28, 2026 /PRNewswire/ -- Amorphical, a developer of nano-amorphous mineral-based pharmacologic agents, today announced the completion of patient enrollment in its Phase 2 FDA clinical trial evaluating its investigational therapy, AMOR-1, for the treatment of hypocalcemia in adults with hypoparathyroidism. The prospective, multinational, multicenter, double-blind, randomized study has successfully enrolled its target cohort, with final primary completion and data readout expected in Q4 2026.

Hypoparathyroidism is a rare endocrine disorder characterized by a deficiency of parathyroid hormone, leading to severe hypocalcemia (low blood calcium levels). The current standard of care relies heavily on lifelong, high-dose daily crystalline calcium supplementation combined with active vitamin D. Long-term consumption of high-dose conventional calcium is associated with severe adverse effects, including renal calcification, kidney stones, and progressive kidney damage. Recent innovation has focused on developing synthetic hormone replacement drugs. However, patients continue to require crystalline calcium supplementation, and the drugs have side effects and are expensive.

Amorphical's AMOR-1 utilizes proprietary nano-amorphous calcium carbonate (ACC) technology, which offers significantly higher calcium absorption and bioavailability compared to traditional crystalline formulations, potentially allowing patients to maintain safe serum calcium levels while substantially reducing their overall elemental calcium intake.

"Achieving full enrollment in our Phase 2 FDA trial is a major milestone for Amorphical and brings us one step closer to redefining the standard of care for hypoparathyroidism," said Eden Ben, Chief Executive Officer of Amorphical. "By leveraging the superior bioavailability of our novel nano-amorphous platform, AMOR-1 is designed to break the cycle of high-dose calcium toxicity. We look forward to analyzing the unblinded data later this year as we continue to advance our regulatory timeline and evaluate strategic commercialization opportunities."

The Phase 2 trial (NCT06547151) evaluates 50 adult participants randomized in a 2:1 ratio to receive either AMOR-1 or a control consisting of conventional crystalline calcium carbonate supplements. During an initial 2-to-4-week replacement phase, patients' baseline calcium supplements are gradually substituted. Participants in the AMOR-1 arm have their total elemental calcium intake safely reduced by 50% compared to their initial baseline intake, while those in the control arm maintain 100% of their initial elemental calcium intake. Following this, patients enter a 10-to-12-week dose maintenance phase, throughout which they are routinely monitored for core safety and efficacy metrics, including comprehensive blood and urine calcium levels.

"Managing hypoparathyroidism has always been a delicate balancing act between treating acute hypocalcemia and avoiding the long-term, devastating renal complications caused by massive daily calcium doses," said the study's lead investigator, Prof. Ilan Shimon, Director of the Institute of Endocrinology and Metabolism at Beilinson Hospital, Rabin Medical Center. "The ability of AMOR-1's nano-amorphous platform to deliver targeted, highly bioavailable calcium means we may finally be able to maintain desired serum calcium levels with half the amount of elemental calcium compared to conventional therapies. If the data confirms these findings, it will be a major step forward for patients suffering from this chronic condition."

With more than a decade of real-world exposure through early access and compassionate use programs, Amorphical enters clinical development with valuable safety and tolerability insights to guide its regulatory pathway. In addition to hypoparathyroidism, the company is advancing clinical programs in pancreatic cancer, Crohn's disease, and osteoporotic fractures. The company's technology is protected by more than 190 patents worldwide.

About Amorphical
Amorphical is a biotechnology company advancing a new class of nano-amorphous mineral pharmacologic agents. Leveraging a proprietary, nature-inspired platform, Amorphical aims to address unmet needs in areas like pancreatic cancer, inflammatory diseases and metabolic disorders by enhancing bioavailability and optimizing pH balance at the cellular level. Supported by nearly 200 patents, extensive real-world exposure, and a GMP-certified manufacturing infrastructure, Amorphical is committed to bringing scientifically validated, disease-modifying mineral therapies to patients.

Learn more at www.amorphical.com and follow Amorphical on LinkedIn.

FINN Partners for Amorphical
Ellie Hanson
[email protected]

SOURCE Amorphical