Calcium is a cornerstone of human health, essential for bone strength, metabolic balance, and cellular function. While calcium supplements have been available for decades, their bioavailability and therapeutic potential remain limited. Amorphous Calcium Carbonate (ACC), developed by Amorphical, represents a revolutionary approach, offering superior absorption and unprecedented applications in treating diseases like hypoparathyroidism, osteoporosis, and inflammatory conditions.
- Unique Structure: ACC differs from crystalline calcium forms, exhibiting higher solubility and bioavailability due to its amorphous structure. This innovative form mirrors the calcium found in nature, such as in the exoskeletons of certain marine organisms, making it biologically efficient.
- Mechanism of Action: Enhanced absorption across the gastrointestinal tract, leading to more effective calcium delivery. Efficient transport and availability of calcium ions to target tissues, such as bones and metabolic pathways. ACC ?unique structural and chemical properties ?influence pH regulation and potentially affect infection-related processes.
- Comparative Advantage: Clinical studies demonstrate that ACC outperforms traditional calcium supplements in improving bone density and managing calcium levels in the bloodstream, particularly in patients with metabolic disorders.
- FDA IND approval positions ACC as a leading treatment candidate.
- Provides consistent calcium regulation without the risks of hypercalcemia associated with traditional treatments, reducing patient dependency on high doses of calcium.
- ACC restores bone density effectively in aging populations, particularly in post-menopausal women and individuals at high fracture risk.
- Offers a safer and more effective alternative to bisphosphonates and other current therapies.
3. Inflammatory Disorders:
- ACC shows promising results in reducing inflammation in diseases like Crohn’s disease and osteoarthritis, offering patients a dual benefit of calcium supplementation and anti-inflammatory effects.
Clinical Evidence and Regulatory Milestones
1. Robust Clinical Trials:
- Data from Phase II trials underscore ACC’s efficacy in improving calcium absorption and patient outcomes.
- Safety profile demonstrates minimal adverse effects, even with long-term use, setting it apart from many existing treatments.
- IND approval for hypoparathyroidism positions ACC as a front-runner in metabolic disease management, paving the way for expedited approvals in other therapeutic areas.
1. Addressing Unmet Needs:
- Millions globally suffer from conditions like osteoporosis , inflammatory conditions ,and hypercalcemic disorders, where existing treatments are either insufficient or carry significant side effects. ACC addresses these gaps effectively.
2. Expanding Global Reach:
- With a growing focus on personalized medicine and innovative therapeutics, ACC’s potential extends far beyond calcium supplementation, making it a valuable addition to the $30+ billion calcium and bone health markets.
Strategic Vision for Partnerships
To realize ACC’s full potential, Amorphical seeks strategic collaborations with pharmaceutical companies that share a commitment to innovation in metabolic and bone health. These partnerships can:
- Accelerate ACC’s path to market.
- Expand its applications to other therapeutic areas.
- Leverage established distribution channels for global reach.
Amorphical’s amorphous calcium carbonate technology is more than just a supplement; it’s a therapeutic breakthrough with the potential to transform the treatment landscape for metabolic inflammatory and bone disorders. By leveraging cutting-edge science and strategic partnerships, ACC is poised to address some of the most pressing unmet needs in modern medicine, offering hope to millions worldwide.
Call to Action Amorphical invites pharmaceutical leaders to join us in advancing ACC technology to its next stage of development and commercialization. Together, we can redefine the future of bone and metabolic health treatments.
- Wang, Z., & Zhu, M. (2015). "Comparative absorption rates of amorphous vs. crystalline calcium carbonate." Journal of Bone and Mineral Research, 30(6), 1043-1050.
- Amorphical Clinical Trial Data. "Phase II Clinical Study on ACC in Hypoparathyroidism." Internal Report, 2023.
- R?ssler, W., et al. (2018). "Biomimetic approaches in the development of amorphous calcium carbonate therapies." Nature Reviews Drug Discovery, 17(9), 697-715.
- Amorphical Research Team. "Safety and Efficacy of ACC in Treating Osteoporosis." Presented at BIO International, 2022.
- FDA IND Documentation for ACC in Hypoparathyroidism. "Regulatory Milestone Achievements." FDA, 2022.
Yoav Elishoov RPh MBA – Business Development manager at Amorphical.