Amorphical announces positive final long-term results from Phase 2 Crohn's disease trial
Novel treatment offers non-immunosuppressive approach for localized acid neutralization and calcium delivery
22 Dec 2025
Amorphical, a developer of nano-amorphous mineral-based pharmacologic agents, has announced positive final long-term follow-up data from its Phase 2 clinical trial evaluating its investigational nano-amorphous Calcium Carbonate (ACC) therapy, for the treatment of moderate-to-severe Crohn's disease.
The full data analysis, encompassing both the double-blind and open-label extension phases, and including a cohort of patients who completed follow-up extending up to 48 weeks post-baseline, confirms the positive interim results reported in September 2025. The data demonstrates meaningful clinical improvement and, importantly, the durability of the clinical response when nano-amorphous ACC is added to best available standard of care (BAT).
"The consistency of the final data and the powerful signal of sustained remission over nearly two years is a significant validation for this program and the potential of our nano-amorphous technology platform," said Eden Ben, Chief Executive Officer of Amorphical. "Completing the analysis with these confirmed results de-risks our program and provides a strong foundation for our planned regulatory discussions."
The trial was conducted at Soroka University Medical Center under the supervision of the ethical committee in Israel. The company is now focused on advancing this therapy into the next phase of clinical development to address the high unmet need in Crohn's disease.
Amorphical plans to engage with the investment community regarding strategic funding opportunities to support a full Phase 2 FDA program, including meetings at the J.P. Morgan Healthcare Conference in San Francisco this January.
"The sustained clinical remission observed with nano-amorphous ACC over long-term follow-up is a compelling finding for patients with moderate-to-severe Crohn's disease," said Dr. Arik Segal, lead investigator from the Department of Gastroenterology at Soroka University Medical Center. "The durability of response strengthens the potential of this novel approach to deliver meaningful, lasting benefit."
The clinical trial randomized 23 subjects (1:1 ACC or Placebo) who then entered an open-label extension phase. The data supports the therapy's novel dual mechanism – it is designed for controlled activity in the small intestine, where it locally neutralizes acidity at inflamed sites and provides bioavailable calcium that supports epithelial repair. This provides a differentiated, non-immunosuppressive therapeutic pathway for Crohn's disease.
Critically, nano-amorphous ACC was well tolerated throughout the study, with no new safety concerns observed during the long-term follow-up period, consistent with the interim report
The final data package confirms and expands upon the interim results, providing crucial long-term follow-up insights on durability. In the 12-week double-blind phase, the ACC group demonstrated a clinically meaningful improvement in patients with moderate-to-severe Crohn's disease, achieving more than double the reduction in disease activity compared to placebo.
Patients treated with ACC showed an average 102-point decrease in CDAI scores versus 47 points with placebo, alongside greater reductions in stool frequency and abdominal pain.
By week 24, patients who began the study on nano-amorphous ACC achieved a mean CDAI reduction of approximately 157 points from baseline, compared with a reduction of about 114 points among patients who started on placebo and switched later, demonstrating a markedly stronger and more sustained clinical improvement with earlier initiation of therapy.
Among the patients who completed at least the 48-week visit (with follow-up extending up to 97 weeks), the therapy demonstrated sustained benefit. Five out of eight patients achieved continuous clinical remission (CDAI <150) through Week 48 and beyond.
These results highlight ACC's potential to rapidly alleviate core symptoms of Crohn's disease when added to standard care, with a favorable safety profile and no treatment-related adverse events reported.