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Beyond Celiac Chosen by 9 Meters Biopharma as Exclusive Patient Organization to Recruit for First-Ever Phase 3 Clinical Trial

Premier Patient Recruiter for Celiac Disease Research, Beyond Celiac Taps Extensive Network to Advance Study

Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3

Philadelphia, PA, Oct. 14, 2020 (GLOBE NEWSWIRE) — Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has been chosen by 9 Meters Biopharma, Inc. (Nasdaq: NMTR) as the exclusive patient organization to recruit for the first-ever Phase 3-stage clinical trial therapeutic for treatment of celiac disease. Beyond Celiac will use its unrivaled connection to the celiac disease community and its powerful online patient database to recruit participants for the study of larazotide acetate, which aims to address leaky gut in celiac disease.

“We really listen to our community’s wants and needs. Because of our extensive connection to the people and commitment to connecting researchers with our community, Beyond Celiac has become the partner of choice for leading biotechnology and pharmaceutical companies such as 9 Meters,” said Beyond Celiac CEO Alice Bast. “This is the furthest a celiac disease clinical trial has gone, and it’s an exciting opportunity for our organization to play a vital role in fulfilling its promise.”

9 Meters Biopharma is evaluating larazotide acetate for celiac disease patients who continue to experience gastrointestinal symptoms while following a gluten-free diet. Designed to tighten junctions between intestinal cells, larazotide acetate would act like shoelaces to help restore leaky junctions to a normal state and would be used in addition to the gluten-free diet. It is being tested at more than 100 clinical sites, with a goal of 525 study participants. Results are expected by the end of 2021.

By partnering with Beyond Celiac for recruitment, 9 Meters Biopharma now has access to the power of Go Beyond Celiac, a secure online patient database with thousands of users who share their celiac disease stories and experiences with researchers and seek to become involved in studies.

“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.”

Celiac disease is a serious genetic autoimmune disorder that affects an estimated 1 in 133 Americans, more than half of whom are still undiagnosed. The disease causes damage to the small intestine, resulting in debilitating symptoms, and if left untreated, can lead to serious long-term health problems including infertility and some types of cancer.

 

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Study: Giving babies wheat very early may prevent celiac disease

Childhood risk for developing the allergic/autoimmune disorder known as celiac disease might be eliminated if infants were exposed to gluten as early as 4 months of age, new British research suggests.

The observation is based on work with 1,300 infants. Half were exposed to solid foods — including wheat protein — at an age that conflicts with current breastfeeding guidelines. Among those who were, none developed celiac disease.

“It was a surprise,” said study author Dr. Gideon Lack. “But if this study is correct, it would indicate that in order to prevent the development of celiac disease, we would need to introduce significant quantities of wheat into a baby’s diet as of 4 months of life.”

But the finding is not the final word on the subject, cautioned Lack, a professor of pediatric allergy and immunology at King’s College London.

“This is one study with a relatively small number of patients,” he said. “And, therefore, it cannot be regarded as conclusive, and clearly demands further study and investigation.”

Celiac disease is an inflammatory condition where consuming gluten damages the small intestine. It can cause poor absorption of nutrients.

“In some ways it’s an allergic disease inasmuch as it is triggered by eating gluten, which is a major wheat constituent, although it’s also present in barley and rye,” Lack said. “And in other ways it is an autoimmune disease, in that the body launches an immune response, and that response becomes redirected against the lining of the small intestine.”

About 1% of the population is affected, he added. In children, celiac disease it can go undiagnosed for many years, leading to poor growth and malnutrition. In adults, it can cause bone-thinning, fatigue and in rare cases, colon cancer.

Celiac patients can manage by avoiding gluten altogether. But there is no known way to prevent the onset of celiac disease. Current guidelines stipulate that celiac risk is not affected by the age at which one is first exposed to gluten.

But Lack and his colleagues put that wisdom to the test during a broad investigation that examined food allergy risk as a whole, rather than celiac disease, specifically.

The team focused on 1,300 English and Welsh infants who were enrolled in a food study between 2009 and 2012.

All had been exclusively breastfed until 13 weeks of age. After that, half continued to be exclusively breastfed through their sixth month. The other half was also exposed to potentially allergy-provoking foods.

Those foods included cow’s milk, eggs, peanuts, sesame, cod fish and wheat. The team aimed to include about 4 grams of wheat protein per week, which contains about 3 grams of gluten.

By age 3, there were seven cases of celiac disease among the breastfeeding group, but zero among the group that was exposed to wheat early.

The American Academy of Pediatrics, the U.S. Centers for Disease Control and Prevention and the U.K. government all urge parents to breastfeed exclusively for six months, giving babies no additional foods or fluids unless medically