phase 3 drug ?

[DJFL77I]

 

Phase 3:

Innovate Biopharmaceuticals, INN-202 (Larazotide Acetate)

In February 2016, Innovate licensed the assets of Alba Therapeutics relating to larazotide acetate, a tight junction regulator. Larazotide acetate (INN-202) is a novel oral peptide that has consistently demonstrated the reduction of symptoms of celiac disease in multiple clinical trials. INN-202 helps restore “leaky” or open junctions to a normal state. INN-202, when ingested prior to a meal, may help keep the tight junctions closed, thus reducing the intestinal-inflammatory process in response to gluten.

 

First Patient Dosed in First Ever Phase 3 Clinical Trial for Celiac Disease | Celiac Disease Foundation

First Patient Dosed in First Ever Phase 3 Clinical Trial for Celiac Disease

On August 13th, 2019, Innovate Biopharmaceuticals, Inc. (Innovate) announced the first patient has been dosed in its Phase 3 clinical trial for patients with celiac disease. The CeD LA 3001 trial is testing larazotide acetate—also known as INN-202—as an adjunct treatment for patients with celiac disease still experiencing symptoms on a gluten-free diet.

Larazotide acetate belongs to a new class of drugs called tight junction regulators. Tight junctions, which are located in the bowel, should remain closed. However, in patients with celiac disease, gluten causes tight junctions to remain open. This spurs inflammation that causes intestinal damage. When taken before a meal, larazotide acetate may help keep tight junctions closed, thus reducing the inflammatory process triggered by gluten.

About 600 patients are expected to enroll in this national, multicenter, placebo-controlled clinical trial. Participants will take the study drug three times a day before meals.

This trial marks the first time a patient has been dosed in a Phase 3 trial for celiac disease. Although celiac disease affects more than 3 million Americans, there are currently no FDA approved treatments. In a press release, Sandeep Laumas, M.D., CEO of Innovate, stated, “We are extremely pleased to start patient dosing in this pivotal Phase 3 trial for larazotide for celiac disease. This brings us closer to our mission of gaining approval for the first ever drug for celiac disease.”

About Innovate Biopharmaceuticals, Inc.

Innovate is a privately owned clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases. For celiac disease, larazotide acetate is the only drug that has met the primary endpoint with statistical significance in a Phase 2b efficacy clinical trial. Larazotide acetate has received Fast Track designation from the FDA for celiac disease.

 

 

Larazotide is undergoing Phase III trials now, with more than 100 clinical sites and ongoing enrollment. Temperato said the trial was designed as a 630 patient, three arm trial that includes a placebo. He expects to perform an interim analysis by mid-2021 and a final analysis at the end of that year. “We want to petition the FDA for conditional approval.” The waiver helps support that.

 

 

[Scott Adams]

Yes, this is great news and we've been following it closely and doing summaries whenever new developments with it are posted:

https://www.celiac.com/search/?q=Larazotide&quick=1&type=cms_records2