Innovate Biopharmaceuticals Doses First Patient in Phase 3 Clinical Trial CeD LA3001

Innovate Biopharmaceuticals (NASDAQ:INNT) has announced it has dosed the first patient in its Phase 3 clinical trial, CeD LA 3001.

As quoted in the press release:

This marks the first time any company has dosed a patient in a Phase 3 trial for celiac disease.

Larazotide acetate, or INN-202, is Innovate’s leading drug candidate for the treatment of celiac disease. The drug is a tight junction regulator designed to help restore “leaky” or open junctions to a normal state. Celiac disease affects approximately 1% of the U.S. population, more than 3 million Americans, and is a high unmet need with no FDA approved treatments.

This Phase 3 study is a national, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial that is expected to enroll approximately 600 patients. The study’s primary objective is to evaluate larazotide acetate as an adjunct therapy for patients with celiac disease who still experience symptoms despite being on a gluten-free diet. Larazotide is an oral therapy taken prior to meals, up to 3 times per day. Larazotide is not systemically absorbed and has a well-established safety profile.

Patrick Griffin, M.D., F.A.C.P., Innovate’s Chief Medical Officer said, “We are thrilled to announce the first patient dosed in our Phase 3 trial. We believe larazotide will have a meaningful impact on celiac patients and provide a therapy where none is approved. Progressing this trial is another step towards bringing a potentially groundbreaking therapy for celiac patients globally.”

Click here to read the full press release.