Recruitment of symptomatic participants in the first celiac disease Phase 3 clinical trial continues
Kate Avery, MPH, Director of Research & Patient Engagement
9 Meters Biopharma, a Raleigh NC based biopharmaceutical company, launched a Phase 3 clinical trial in celiac disease last June. The company is focused on developing treatments for gastrointestinal diseases with unmet needs, including celiac disease and short bowel syndrome. The trial, called the CeDLara Study (CeD-LA-3001), is taking place at over 100 locations in the US and Canada.
The CeDLara Study is testing larazotide acetate in people with celiac disease who continue to have symptoms even while following the gluten-free diet. Larazotide acetate is designed to tighten the adhesions between cells lining the small intestine, called tight junctions. In people with celiac disease, gluten causes these tight junctions to break down, which allows gliadin (a component of gluten) to enter this space between and underneath the intestinal cells. Once in the “wrong” place, the gliadin prompts an inflammatory response from the immune system. This “leaky gut” is thought to be the gateway to many autoimmune diseases, including celiac disease. Larazotide acetate makes the tight junctions more secure, keeping gliadin from passing through.
>In the US, phase 3 clinical trials are the last step in the drug development process before potential treatments are approved by the FDA and available to patients. Phase 3 trials are designed to confirm the effectiveness of the treatment in a large group of participants after safety and effectiveness have been seen in earlier studies. Larazotide acetate is the first potential celiac disease treatment to reach Phase 3 clinical trials. It is intended to be used in conjunction with the gluten-free diet. Research shows many people with celiac disease continue to have symptoms, including abdominal symptoms such as, pain, cramping, bloating, and gas, even while following a strict gluten-free diet. “Having the first potential treatment reaching late stages of clinical development is an important milestone and great news for the celiac community. Beyond Celiac is committed to supporting and accelerating recruitment efforts with this trial, which hopefully will bring the first new treatment to celiac patients,” noted Salvo Alesci, MD, Beyond Celiac Chief Scientist and Strategy Officer.
Larazotide acetate was one of the first potential celiac disease treatments to enter into clinical trials. A number of companies have developed the drug over the years, including Alba Therapeutics and Innovate Biopharmaceuticals. A 2014 Phase 2b study conducted by Alba Therapeutics showed a 26% decrease in symptomatic days in participants on the lowest dose of larazotide acetate, but no difference between placebo and larazotide acetate at two higher doses. A 2020 merger created 9 Meters Biopharma. This Phase 3 trial started last year, and is focused on reducing symptoms in those who have persistent symptoms while following the gluten-free diet. Results are expected as early as 2021. “Our conservative estimate is that our celiac disease program is at least two years ahead of everyone else’s,” said John Temperato, president and CEO of 9 Meters Biopharma. “Beyond Celiac is going to help us across the finish line in developing the effective treatments that celiac patients deserve.”
Participants in the CeDLara Study will continue their normal gluten-free diet while taking larazotide acetate or placebo 3 times per day. Participants will track their symptoms in an electronic symptom diary, first daily, and then weekly. There is no gluten challenge required during the study. The study is randomized and double-blind, meaning participants are randomly assigned to either the placebo or study treatment group, and neither study staff nor the participant knows which they are receiving. The study is looking for participants who continue to have abdominal cramps, abdominal pain, bloating or gas while following the gluten-free diet.
The COVID-19 pandemic put many clinical trials on hold, as sites adjusted and determined how to keep clinical trial participants safe. Many clinical trials have safely resumed, with precautions in place for study participants. Study locations for the CeDLara study are following FDA and local public health guidelines taking precautions including mask-wearing, physical distancing, and remote visits (ie, telemedicine) wherever feasible.
Beyond Celiac is partnering with 9 Meters to recruit for this study as part of our commitment to accelerating research. You can learn more about the study at Celiac-Study.com or at ClinicalTrials.gov.