Amorphical has announced positive interim results from its ongoing open-label clinical trial evaluating its investigational therapy for the treatment of moderate-to-severe Crohn’s disease.
The data suggest that the investigational therapy, when added to best available therapy, supports meaningful clinical improvement and remission. The drug has been well tolerated, with no safety concerns observed to date.
Crohn’s disease is a chronic inflammatory bowel disease with significant unmet needs, particularly for patients who do not respond to or cannot tolerate existing therapies. The investigational therapy, a proprietary nano amorphous calcium carbonate (ACC) agent, is designed to target the acidic microenvironment in the gut, offering a unique, non-immunosuppressive approach to supporting tissue repair and clinical improvement.
“We are very encouraged by these interim results, which show a clear signal of clinical improvement and remission with this investigational therapy,” said Arik Segal, a lead investigator from the Department of Gastroenterology at Soroka University Medical Center.
“The data supports our hypothesis that normalizing the acidic microenvironment with amorphous calcium carbonate can be a valuable, non-immunosuppressive treatment strategy. We look forward to the continued progress of this trial and the unblinding of the double-blind phase.”
The ongoing study has enrolled 22 patients, 17 of whom have open-label data available. At baseline, 70% of patients were already on at least one immunosuppressive or advanced therapy. The interim data reflects varying follow-up durations: 12 out of 17 patients experienced a clinical improvement of >100 CDAI (Crohn’s Disease Activity Index) points from baseline; eight out of 17 patients achieved clinical remission (CDAI <150); four out of five patients (80%) with more than 10 months of follow-up in the open-label phase showed sustained remission.
“This positive interim data in Crohn’s disease represents a significant milestone for our company and for the patients seeking new treatment options,” said Eden Ben, CEO of Amorphical.
“The results strengthen our confidence in the broad potential of our nano-amorphous mineral technology to address conditions where underlying pH plays a key role. We are deeply committed to advancing this program and others, and bringing a new class of therapy to the market.”
The study remains blinded during the double-blind phase. Additional insights are expected as the data becomes unblinded in November and long-term follow-up progresses.
In addition to Crohn’s disease, the company is advancing clinical programmes in pancreatic cancer, hypoparathyroidism, and osteoporotic fractures.
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