An analysis by an independent statistician of the ongoing Phase 3 trial for Larazotide, referred to as CedLara, has concluded that a substantial number of new patients would have to be added to the existing trial in order to get scientifically meaningful results. 9 Meters determined that the additional number of patients needed was too large to support the continuation of the trial. The Celiac Disease Foundation was proud to partner with 9 Meters to recruit patients for this trial.
We are, of course, disappointed. Larazotide was the only potential celiac disease drug in Phase 3 clinical trials, and we all understand how eager the celiac patient community is for a therapeutic adjunct to the gluten-free diet. “We were hopeful that this study of larazotide would lead to a treatment option for those with celiac disease but also fully recognize the challenges and complexities of the disease and the ability to effectively measure outcomes,” said Dr. Patrick Griffin, MD, FACP, Chief Medical Officer of 9 Meters. “We plan to continue to analyze the data over the coming weeks to determine if other individual or groups of celiac symptoms included in the CedPRO (e.g., headache and fatigue) might benefit from treatment with larazotide. We are grateful to all the patients with celiac disease, their families, and the investigators who participated in the trial and contributed greatly to our understanding of larazotide.”
For context, it might be helpful to understand that 90% of all proposed drugs fail in the clinical trial stage, and that almost 60% fail in Phase 3 trials. This is one reason why drug development is so expensive and why we have spent so much time and energy working to lower the cost of drug development for researchers through our iQualifyCeliac patient recruitment platform.
Drug development is inherently risky. We accept that fact and hope that you do as well. Thanks to your generous and sustained support, we will continue to do everything we can to accelerate the development of drugs that will relieve the suffering of our patient community and that we hope will, eventually, cure celiac disease.
You can read the 9 Meters announcement about Larazotide here.
Would you like to participate in celiac disease research? Join the thousands of others in the iCureCeliac® patient registry who are providing critical insights into life with celiac disease. Your participation will help create better diagnostic tools and treatments, governmental policy changes, and access to new and innovative clinical trials nationwide, which may, one day, cure celiac disease. Click here to see if you qualify for a study or clinical trial today.