Amorphical Completes Full Enrollment in Phase 2 Trial of AMOR-1 for Hypoparathyroidism, Data Readout Expected Q4 2026
核心洞察
Amorphical (搜索) announced full patient enrollment in its Phase 2 FDA clinical trial evaluating AMOR-1, a nano-amorphous calcium carbonate (搜索) therapy for hypocalcemia (搜索) in adults with hypoparathyroidism (搜索).
The double-blind, randomized study enrolled 50 participants across multiple countries, with patients in the AMOR-1 arm receiving a 50% reduction in elemental calcium intake compared to baseline.
AMOR-1's proprietary nano-amorphous platform aims to deliver superior calcium bioavailability, potentially breaking the cycle of high-dose calcium toxicity associated with conventional crystalline supplements.
Amorphical (搜索), a biotechnology company based in Nes Ziona, Israel, announced on July 28, 2026, the completion of patient enrollment in its Phase 2 FDA clinical trial evaluating AMOR-1, an investigational nano-amorphous calcium carbonate (搜索) (ACC) therapy for the treatment of hypocalcemia (搜索) in adults with hypoparathyroidism (搜索). The prospective, multinational, multicenter, double-blind, randomized study has successfully enrolled its target cohort, with final primary completion and data readout expected in the fourth quarter of 2026.
Hypoparathyroidism (搜索) is a rare endocrine disorder characterized by a deficiency of parathyroid hormone, leading to severe hypocalcemia (搜索). The current standard of care relies heavily on lifelong, high-dose daily crystalline calcium supplementation combined with active vitamin D. However, long-term consumption of high-dose conventional calcium is associated with severe adverse effects, including renal calcification, kidney stones, and progressive kidney damage. While recent innovation has focused on developing synthetic hormone replacement drugs, patients continue to require crystalline calcium supplementation, and these drugs carry their own side effects and high costs.
Trial Design and Endpoints
The Phase 2 trial, identified as NCT06547151, enrolled 50 adult participants randomized in a 2:1 ratio to receive either AMOR-1 or a control consisting of conventional crystalline calcium carbonate supplements. The study is structured in two phases: an initial 2-to-4-week replacement phase, during which patients' baseline calcium supplements are gradually substituted, followed by a 10-to-12-week dose maintenance phase. 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. Throughout the maintenance phase, patients are routinely monitored for core safety and efficacy metrics, including comprehensive blood and urine calcium levels.
A Novel Platform Addressing Unmet Need
AMOR-1 utilizes Amorphical (搜索)'s proprietary nano-amorphous calcium carbonate (搜索) technology, which offers significantly higher calcium absorption and bioavailability compared to traditional crystalline formulations. This enhanced bioavailability may allow patients to maintain safe serum calcium levels while substantially reducing their overall elemental calcium intake, potentially mitigating the long-term renal complications associated with conventional high-dose calcium therapy.
"Managing hypoparathyroidism (搜索) has always been a delicate balancing act between treating acute hypocalcemia (搜索) and avoiding the long-term, devastating renal complications caused by massive daily calcium doses," said Prof. Ilan Shimon, Director of the Institute of Endocrinology and Metabolism at Beilinson Hospital, Rabin Medical Center, and the study's lead investigator. "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."
Strategic Outlook
Eden Ben, Chief Executive Officer of Amorphical (搜索), described the enrollment milestone as a major step toward redefining the standard of care for hypoparathyroidism (搜索). "By leveraging the superior bioavailability of our novel nano-amorphous platform, AMOR-1 is designed to break the cycle of high-dose calcium toxicity," Ben said. "We look forward to analyzing the unblinded data later this year as we continue to advance our regulatory timeline and evaluate strategic commercialization opportunities."
Amorphical (搜索) enters this clinical development phase with more than a decade of real-world exposure through early access and compassionate use programs, providing valuable safety and tolerability insights to guide its regulatory pathway. Beyond hypoparathyroidism (搜索), the company is advancing clinical programs in pancreatic cancer, Crohn's disease, and osteoporotic fractures. Its technology platform is protected by more than 190 patents worldwide, supported by a GMP-certified manufacturing infrastructure.