Shots:
- ACC therapies introduce a novel treatment approach by modulating local pH, promoting bone remodeling, and reducing inflammation, with potential applications in osteoarthritis, calcium deficiencies, late-stage cancers, and bone disorders.
- Amorphical’s AMOR-18 showed encouraging results in an interim Phase II clinical trial involving COVID-19 patients.
- PharmaShots speaks with Eden Ben, CEO of Amorphical, to discuss the company’s nano-mineral platform and key insights from the interim analysis of the Phase II AMCS-COVID-001 study.
Saurabh: Can you elaborate on how the AMOR-18 mechanism differs from existing COVID-19 treatments in terms of efficacy and safety?
Eden: AMOR-18, based on stabilized Amorphous Calcium Carbonate (ACC), offers a fundamentally different approach to treating COVID-19. While most therapies like antivirals and steroids either target viral replication or broadly suppress the immune system, AMOR-18 directly modulates the acidic microenvironment that drives viral entry, fusion, replication, and inflammation.
Our nanometric ACC particles penetrate mucosal membranes and release alkaline carbonate ions to neutralize excess protons and restore physiological pH. This pH modulation not only disrupts virus–cell interactions, but improves tissue oxygenation, and reduces inflammatory damage. At the same time, the calcium component addresses the hypocalcemia often seen in severe COVID-19 patients, potentially strengthening their natural host defenses.
The clinical data from our Phase 1/2 trial highlight this unique efficacy and safety.
In short, AMOR-18 sets itself apart by targeting the underlying acidosis that drives disease progression, while showing strong safety and efficacy signals in preventing deterioration and accelerating recovery.
Saurabh: Can you give us an insight into the interim P-II (AMCS-COVID-001) trial analysis of AMOR-18?
Eden: The interim Phase II analysis of the AMCS-COVID-001 study provided encouraging signals of both efficacy and safety. This was a prospective, randomized, double-blind, placebo-controlled trial conducted across three Israeli university hospitals.
Sixty hospitalized patients with moderate-to-severe COVID-19 were enrolled and randomized 1:1 to receive either AMOR-18 (sublingual plus inhaled ACC) alongside Best Available Treatment (BAT), or placebo plus BAT.
The interim results showed:
- Prevention of deterioration: None of the patients treated with AMOR-18 were transferred to ICU or died, compared to 23% ICU transfers and 10% deaths in the placebo arm.
- Improvement rates: 93% of patients in the AMOR-18 group demonstrated clinical improvement versus 73% in the placebo arm.
- Recovery and discharge: All patients in the active arm were discharged within 10 days, while recovery was slower and less consistent in the placebo arm.
- Safety: AMOR-18 was very well tolerated. No serious drug-related adverse events were reported; only one case of mild constipation occurred, which is a common effect associated with calcium intake.
These findings suggest that AMOR-18 not only accelerates recovery but also plays a significant role in preventing critical deterioration, which is the most important clinical outcome in managing hospitalized COVID-19 patients. The consistency of results across different patient subgroups, including age, gender, comorbidity, and vaccination status, adds further confidence to the robustness of the effect.
Saurabh: What are the next steps for Amorphical in advancing AMOR-18 into P-III trials and securing global regulatory approvals?
Eden: While the global urgency for COVID-19 has passed, we’ve made a strategic decision to leverage our platform for a broader range of therapeutic applications. The compelling clinical results and unique mechanism of action demonstrated in our COVID-19 trial provide a strong foundation for our technology, paving the way for future development in other respiratory diseases.
Our focus is now on advancing therapies for chronic conditions like COPD and other inflammatory lung conditions, where our approach can deliver significant clinical benefits. This is a key part of our strategy, but it’s important to note that it’s just one piece of a much larger pipeline.
We are also prioritizing our ongoing programs in other therapeutic areas. These programs aim to address the underlying drivers of disease in oncology, metabolic, endocrine, and musculoskeletal conditions. By building on the success of our initial studies, we are pursuing a larger, more impactful market opportunity across these diverse indications.
Saurabh: Beyond COVID-19, Amorphical is advancing nano amorphous mineral-based therapies across multiple human and veterinary indications. Could you provide a brief overview of the active trials currently underway?
Eden: We are leveraging our amorphous nano-mineral platform to address several high-impact areas.
Our lead program is currently in a Phase 2 FDA-regulated trial for hypoparathyroidism. This study is evaluating our pharmacological agent’s superior absorption and bioavailability to provide better calcium management for patients with this rare endocrine disorder.
Additionally, we are conducting Phase 2 clinical studies in three other major indications:
- Crohn’s disease: Targeting inflammation healing through our pH-modulating mechanism.
- Stage 4 Pancreatic Cancer: Utilizing nano-amorphous mineral-based pharmacologic agents to address the acidic tumor microenvironment.
- Osteoporotic Fractures: Leveraging the agents’ potential to improve bone density and accelerate fracture healing.
Together, these programs demonstrate how Amorphical is harnessing a single nano-mineral mechanism for a broad range of therapeutic applications across bone, inflammatory, and oncological diseases. This strategic approach maximizes the platform’s potential and positions us for success across diverse markets.
Saurabh: How do ACC-based therapies help reduce tumor growth and improve outcomes for cancer patients?
Eden: Our nano-amorphous mineral agents directly target the highly acidic microenvironment of tumors. This acidity is a major driver of cancer proliferation and is a direct result of the Warburg effect, where cancer cells produce energy through rapid glycolysis, leading to an excess of lactic acid. Our therapeutic agent aims to act as a pH buffer, dissolving in the acidic tumor microenvironment to neutralize it and restore a more normal physiological pH.
By normalizing the pH, this therapy aims to disrupt several cancer-promoting processes. It is designed to slow tumor growth, reduce the tumor’s ability to invade surrounding tissues, and potentially enhance the efficacy of other cancer treatments. This mechanism has shown promise in preclinical studies, where our agent has slowed tumor growth and worked synergistically with standard chemotherapies. The encouraging results seen across oncological, inflammatory, and bone diseases have motivated us to advance this platform, with planned clinical trials to validate these benefits and assess the potential for improved patient outcomes.
About the Author:
Eden Ben
Eden Ben is the Chief Executive Officer at Amorphical. He possesses a strong foundation in biomedical engineering and management. A proficient business and marketing strategist, Eden completed his graduation from Afeka Tel Aviv Academic College of Engineering in Biomedical/Medical Engineering with a specialization in the mechanics of physiological systems.
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